Myocardial Infarction With Non-Obstructive Coronary ArteriesPhase 4PROMISENCT05122780

Prognostic Value of Precision Medicine in Patients With MINOCA (PROMISE Trial).

A Phase 4 study testing Coronary angiography, OCT imaging and Percutaneous coronary intervention (PCI): in people with Myocardial Infarction With Non-Obstructive Coronary Arteries, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 3 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Myocardial Infarction With Non-Obstructive Coronary Arteries
What is being tested?: Coronary angiography, OCT imaging and Percutaneous coronary intervention (PCI):
Type of treatment: Pill or oral medicine, Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 3 sitesItaly
Study dates: 1 Jul 2021to Jul 2025
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ability to give informed consent to the study
Age > 18y
MINOCA diagnosis, defined as:
Acute myocardial infarction (based on Fourth Universal Definition of Myocardial Infarction Criteria):
Evidence of non-obstructive coronary artery disease on angiography (i.e., no coronary artery stenosis >50%) in any major epicardial vessel.
No specific alternate diagnosis for the clinical presentation (i.e. non-ischemic causes of myocardial injury such as sepsis, pulmonary embolism, and myocarditis).

Who cannot join

Inability or limited capacity to give informed consent to the study
Age < 18 y
Pregnant and breast-feeding women or patients considering becoming pregnant during the study period will be excluded. For women of childbearing potential, the use of a highly effective contraceptive measure is required in order to be included in the study. "Highly effective contraceptive" is defined in accordance with the recommendations of the Clinical Trial Facilitation Group as a contraceptive measure with a failure rate of less than 1% per year (https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2020_09_HMA_CTFG_Contraception_guidance_Version_1.1_updated.pdf).
Alternate diagnosis for the clinical presentation (i.e. non-ischemic causes of myocardial injury such as sepsis, pulmonary embolism, valve disease, hypertrophic cardiomyopathy and myocarditis). Also patients presenting with Takotsubo syndrome will be excluded.
Contraindication to contrast-enhanced CMR, eg, severe renal dysfunction (glomerular filtration rate <30 mL/min), non-CMR-compatible pacemaker or defibrillator.
Contraindication to drugs administrated: e.g a history of hypersensitivity to drugs administrated or its excipients, significant renal and/or hepatic disease.
Patients with comorbidities having an expected survival <1-year will be excluded.

Trial locations and contacts

3 sites in 1 country.

Italy3 sites

Centro Cardiologico Monzino
Milan
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, 00168
IRCCS Policlinico San Donato
San Donato Milanese, 20097

Other trials in Italy

About this study

Official title: PROgnostic Value of Precision Medicine in Patients With Myocardial Infarction and Non-obStructive Coronary artEries: the PROMISE Trial.

The aim of our study is to evaluate if the use of a precision-medicine approach with a specific therapy tailored on the underlying pathogenic mechanism will improve the quality-of-life in MINOCA patients. The investigators further aim at investigating wherever a precision-medicine approach will improve the prognosis, healthcare related costs, and if that a different profile of plasma biomarkers and microRNAs may serve as diagnostic tools for detecting specific causes of MINOCA and to assess response to therapy. Finally, beyond its pivotal role in differential diagnosis, the investigators hypothesize that cardiac magnetic resonance (CMR) may provide a morphological and functional cardiac characterization as well as help in the prognostic stratification.

Read the detailed description

PROMISE study is a randomized multicenter prospective superiority phase IV trial comparing "precision medicine approach" versus "standard of care" in improving the prognosis and/or the quality-of-life of patients presenting with MINOCA. Patients will be randomized 1:1 to "precision medicine approach" consisting of a comprehensive diagnostic work up aim at elucidating the pathophysiological mechanism of MINOCA and consequently a tailored pharmacological approach versus "standard of care" consisting of standard diagnostic algorithm and therapy for myocardial infarction.

The aim of the study is to evaluate if the use of a precision-medicine approach with a specific therapy tailored on the underlying pathogenic mechanism will improve the quality-of-life in MINOCA patients (primary objective). The investigators further aim at investigating wherever a precision-medicine approach will improve the prognosis, healthcare related costs, and if that a different profile of plasma biomarkers and microRNAs may serve as diagnostic tools for detecting specific causes of MINOCA and to assess response to therapy (secondary objectives). Finally, beyond its pivotal role in differential diagnosis, the investigators hypothesize that cardiac magnetic resonance (CMR) may provide a morphological and functional cardiac characterization as well as help in the prognostic stratification (secondary objective).

The study is a multicentre trial involving 3 centers: IRCCS Fondazione Policlinico Universitario A. Gemelli (Study Promoter), Centro Cardiologico Monzino IRCCS, IRCCS Policlinico San Donato.

It will include 180 patients aged >18 years hospitalized for MINOCA randomized 1:1 to a "precision medicine approach" consisting of a comprehensive diagnostic work-up, analysis of circulating biomarkers and micro RNA expression profile and pharmacological treatment specific for the underlying cause versus a "standard approach" consisting of routine diagnostic work-up and standard medical treatment.

Conditions: Myocardial Infarction With Non-Obstructive Coronary Arteries
Being tested: Coronary angiography, OCT imaging, Percutaneous coronary intervention (PCI):, Acetylcholine provocative test, TT-Echocardiography
Keywords: MINOCA, coronary spasm, OCT
Medical subject headings: MINOCA, Angina Pectoris, Variant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Coronary angiographyProcedure or surgery
coronary angiography will be performed via the transradial or transfemoral approach with the use of a 6F sheath. Coronary angiography will be performed within 90 minutes from hospital admission in patients presenting with persistent ST-segment elevation, and within 48 hours in patients presenting with non-ST-segment elevation. Unfractionated heparin (initial weight-adjusted intravenous bolus of 60 IU/Kg, with repeat boluses to achieve an activated clotting time of 250 to 300 seconds) was administered in all patients. If evidence of plaque rupture
OCT imagingDiagnostic test
OCT imaging will be performed in the culprit artery in all patients randomized to the "precision medicine approach". A 0.014-inch guidewire will be placed distally in the target vessel and an intracoronary injection of 200 µg of nitroglycerine will be performed. Frequency domain OCT (FD-OCT) images are acquired by a commercially available system (C7 System, LightLab Imaging Inc/ St Jude Medical, Westford, MA) connected to an OCT catheter (C7 Dragonfly; LightLab Imaging Inc/ St Jude Medical, Westford, MA), which was advanced to the culprit lesion. The FD-OCT run will be performed using the integrated automated pullback device at 20 mm/s. During image acquisition, coronary blood flow will be replaced by continuous flushing of contrast media directly from the guiding catheter at a rate of 4 ml/s with a power injector in order to create a virtually blood-free environment.
Percutaneous coronary intervention (PCI):Procedure or surgery
PCI with stent implantation will be considered in selected cases with evidences of plaque rupture
Acetylcholine provocative testDiagnostic test
ACh will be administered in a stepwise manner into the left coronary artery (LCA) (20-200 μg) or into the right coronary artery (RCA) (20-50 μg) over a period of 3 min with a 2-3 min interval between injections. Coronary angiography will be performed 1 min after each injection of these agents and/or when chest pain and/or ischaemic ECG shifts were observed. The decision of testing with provocative test LCA or RCA as first will be left to the discretion of the physicians; both LCA and RCA will be tested if the first test was negative. Angiographic responses during the provocative test will be assessed in multiple orthogonal views in order to detect the most severe narrowing and/or analysed by using computerized quantitative coronary angiography (QCA-CMS, Version 6.0, Medis-Software, Leiden, The Netherlands).
TT-EchocardiographyDiagnostic test
TT-Echo will be used to calculate left and right ventricular and atrial dimensions, left and right ventricular systolic function, transmitral flow Doppler spectra, mitral and tricuspidal valve annulus tissue Doppler spectra, ejection time and stroke volume, inferior vena cava, aorta and pulmonary artery diameters and Doppler spectra, according to the recommendations of the American Society of Echocardiography.
TE/contrast echocardiographyDiagnostic test
In patients with angiographic evidence or suspicion of distal microembolization, TE-Echo consisting of an echocardiographic probe inserted in to the oesophagus will be used to detect a hidden cardioembolic source (i.e. left atrial thrombus); in patients with suspected left ventricular source of cardioembolism, contrast echocardiography consisting of a 0.3ml solution of SONOVUE will be used.
Cardiac magnetic resonanceDiagnostic test
CMR will be performed during hospital stay on a 1.5-T system equipped with a 32-channel cardiac coil. Patients underwent conventional CMR including cine, T2-weighted, first pass perfusion, and conventional breath-held late gadolinium enhancement (LGE).
Circulating biomarkersDiagnostic test
Blood sampling for circulating biomarkers and miRNA expression profile at the time or within 12 hours of coronary angiography. Blood sampling will be processed and analysed in the research laboratory of the Department of Cardiovascular Science. Biological aliquots will be preserved at XBiogem Biobank at Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome (see section 33).
Antiplatelet DrugDrug
acetylsalicylic acid (loading dose 250mg intravenously followed by 75mg orally) + P2Y12 receptor inhibitor (i.e. Clopidogrel, 300 or 600mg loading dose orally, followed by 75 mg orally daily).
StatinDrug
i.e. atorvastatin; dosages titrated on the patient's clinical characteristics
Beta blockerDrug
i.e. bisoprolol; dosages titrated on blood pressure, ECG, heart rate
ACEi/ARBDrug
i.e. ramipril; dosages titrated on blood pressure, ECG, heart rate
CCBDrug
i.e. diltiazem; dosages titrated on blood pressure, ECG, heart rate
NitratesDrug
i.e. nitroglycerine; dosages titrated on blood pressure, ECG, heart rate
AnticoagulantDrug
i.e. warfarin; the selection of the anticoagulant agent will be based on the clinical scenario, contraindications etc

Study groups in NCT05122780
Study group	Role	What they receive
"Precision medicine approach"	Active comparator	Comprehensive diagnostic work-up with: * Coronary angiography and ventriculography in all patients * OCT at the time of coronary angiography in the cath-lab. * Acetylcholine provocative test (to assess the presence of coronary vasospasm) at the time of coronary angiography in the cath-lab. * TE-Echo and/or CE-Echo (if distal/microvascular embolization is suspected) * Blood sampling for circulating biomarkers and miRNA expression profile * Trans-thoracic echocardiography in all patients during the index hospitalization * CMR in all cases during the index hospitalization. Targeted pharmacological treatment specific for the underlying cause: * DAPT ± stent implantation (if required), statins, beta-blockers, ACEi/ARB (in case of evidence of plaque rupture/erosion) * CCB and/or nitrates (in case of documentation of coronary vasospasm) * Anticoagulation (in case of coronary embolism). Receives: Procedure: Coronary angiography; Diagnostic Test: OCT imaging; Procedure: Percutaneous coronary intervention (PCI):; Diagnostic Test: Acetylcholine provocative test; Diagnostic Test: TT-Echocardiography; Diagnostic Test: TE/contrast echocardiography; Diagnostic Test: Cardiac magnetic resonance; Diagnostic Test: Circulating biomarkers; Drug: Antiplatelet Drug; Drug: Statin; Drug: Beta blocker; Drug: ACEi/ARB; Drug: CCB; Drug: Nitrates; Drug: Anticoagulant
"Standard approach"	Other	Routine diagnostic work-up with: * Coronary angiography and ventriculography * Transthoracic echocardiography in all patients during the index hospitalization * CMR with contrast media only if clinically indicated (i.e. to exclude myocarditis or takotsubo syndrome) Standard medical treatment with: * DAPT in all patients * Beta-blockers (if indicated by the clinical context, i.e. documentation of left ventricular ejection fraction <50%, tachycardia). * High intensity statins in all patients * ACEi/ARB (if clinically indicated). Receives: Procedure: Coronary angiography; Diagnostic Test: TT-Echocardiography; Diagnostic Test: Cardiac magnetic resonance; Drug: Antiplatelet Drug; Drug: Statin; Drug: Beta blocker; Drug: ACEi/ARB

What is being measured

The primary outcome is the main question the study is designed to answer.

Angina status
Angina status will be evaluated using the single-item "angina stability scale" and the two-item "angina frequence scale" of the Seattle Angina Questionnaire (SAQ).
Scores are calculated by summing items within a dimension and transforming it to a 0-100 scale, where 0 is the worst and 100 the best possible level of health.
- To reduce the risk of detection and performance bias, a team of 2 cardiologists blinded to group allocation and belonging to an external cardiology unit will submit and collate the questionnaires from study participants.
Measured: 1-year follow-up
eattle Angina Questionnaire (SAQ)
Quality of life will be evaluated using the nine-item scale of "physical limitations scale", the three-item "treatment satisfaction scale" and two-item "disease perception scale" of the Seattle Angina Questionnaire (SAQ).
Scores are calculated by summing items within a dimension and transforming it to a 0-100 scale, where 0 is the worst and 100 the best possible level of health.
- To reduce the risk of detection and performance bias, a team of 2 cardiologists blinded to group allocation and belonging to an external cardiology unit will submit and collate the questionnaires from study participants.
Measured: 1-year follow-up

Secondary outcomes (15)

Rates of major adverse cardiovascular events
Rates of major adverse cardiovascular events (MACE; composite of all-cause mortality; re-hospitalization for myocardial infarction, stroke or heart failure; repeated coronary angiography) will be evaluated at 1-year follow-up in MINOCA patients.
Measured: 1-year follow-up
Healthcare primary related-costs
Healthcare primary related costs will be evaluated as mean costs (including procedures, tests, medicines).
Measured: 1-year follow-up
Healthcare secondary related-costs
Healthcare secondary related-costs will be evaluated as mean quality adjusted life year (QALY) gained.
Measured: 1-year follow-up
Healthcare secondary related-costs
Healthcare secondary related-costs will be evaluated as the incremental cost-effectiveness ratio (ICER) expressed as the cost per QALY.
Measured: 1-year follow-up
Ability of different circulating biomarkers as diagnostic biomarker and stratification tool for specific causes of MINOCA.
Measurement of cardiac circulating biomarkers:
-miRNAs (miR-16, miR-26a, miR-145, miR-222, miR-155-5p, miR-483-5p, miR-45): to measure miRNA reverse transcriptase polymerase chain reaction (RT-PCR) will be employed and results will be expressed in relative expression (2-ΔΔCT Method).
Measured: during index hospitalization (at the time or within 12 hours of coronary angiography)
Ability of different circulating biomarkers as diagnostic biomarker and stratification tool for specific causes of MINOCA.
Measurement of cardiac circulating biomarkers:
-Endothelin 1: It will be assessed through ELISA immunoassay and results will be expressed in Picograms per millilitre (pg/mL).
Measured: during index hospitalization (at the time or within 12 hours of coronary angiography)
Ability of different circulating biomarkers as diagnostic biomarker and stratification tool for specific causes of MINOCA.
Measurement of cardiac circulating biomarkers:
-Neuropeptide Y: It will be assessed through ELISA immunoassay and results will be expressed in Picograms per millilitre (pg/mL).
Measured: during index hospitalization (at the time or within 12 hours of coronary angiography)
Ability of different circulating biomarkers as diagnostic biomarker and stratification tool for specific causes of MINOCA.
Measurement of cardiac circulating biomarkers:
-soluble CD40 ligand: It will be assessed through ELISA immunoassay and results will be expressed in Picograms per millilitre (pg/mL).
Measured: during index hospitalization (at the time or within 12 hours of coronary angiography)
Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.
Morphological cardiac characterization will be assessed by measurement of left and right ventricle volumes (in ml or ml/m2).
Measured: from day 3 to day 7 from the acute coronary event
Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.
Morphological cardiac characterization will be assessed by measurement of the presence of myocardial edema using T2-weighted sequences and a 17 segments assessment model of cardiac segmentation.
Measured: from day 3 to day 7 from the acute coronary event
Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.
Morphological cardiac characterization will be assessed by measurement of the presence of defect of perfusion using first pass perfusion sequences and a 17 segments assessment model of cardiac segmentation.
Measured: from day 3 to day 7 from the acute coronary event
Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.
Morphological cardiac characterization will be assessed by measurement of the presence of fibrosis using late gadolinium enhancement sequences and a 17 segments assessment model of cardiac segmentation (estimated as LGE % of the cardiac segment involved).
Measured: from day 3 to day 7 from the acute coronary event
Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.
Morphological cardiac characterization will be assessed by measurement of the presence of myocardial infarct size (estimated as grams or % of left ventricular myocardial mass).
Measured: from day 3 to day 7 from the acute coronary event
Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.
Functional cardiac characterization will be assessed by measurement of right and left ventricles eject fraction (estimated as %).
Measured: from day 3 to day 7 from the acute coronary event
Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.
Functional cardiac characterization will be assesaed by measurement of regional kinetic abnormalities using a 17 segments assessment model of cardiac segmentation.
Measured: from day 3 to day 7 from the acute coronary event

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 2021Jul 2025

First posted17 Nov 2021
Study start1 Jul 2021
Primary completionJul 2025 (estimated)
Study completionJul 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Myocardial Infarction With Non-Obstructive Coronary ArteriesStudies of the same condition, open and under way.
More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Patients will be randomized 1:1 (using an online software available 24h/24h) to "precision medicine approach" vs "standard approach".
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05122780
Sponsor's protocol ID: GR-2019-12370197
Acronym: PROMISE
Status last verified: Jul 2024
First submitted: 23 Jul 2021
Last updated: 26 Jul 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Tamis-Holland JE, Jneid H, Reynolds HR, Agewall S, Brilakis ES, Brown TM, Lerman A, Cushman M, Kumbhani DJ, Arslanian-Engoren C, Bolger AF, Beltrame JF; American Heart Association Interventional Cardiovascular Care Committee of the Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; and Council on Quality of Care and Outcomes Research. Contemporary Diagnosis and Management of Patients With Myocardial Infarction in the Absence of Obstructive Coronary Artery Disease: A Scientific Statement From the American Heart Association. Circulation. 2019 Apr 30;139(18):e891-e908. doi: 10.1161/CIR.0000000000000670.
PubMed 30913893
Niccoli G, Scalone G, Crea F. Acute myocardial infarction with no obstructive coronary atherosclerosis: mechanisms and management. Eur Heart J. 2015 Feb 21;36(8):475-81. doi: 10.1093/eurheartj/ehu469. Epub 2014 Dec 18.
PubMed 25526726
Del Buono MG, Montone RA, Iannaccone G, Meucci MC, Rinaldi R, D'Amario D, Niccoli G. Diagnostic work-up and therapeutic implications in MINOCA: need for a personalized approach. Future Cardiol. 2021 Jan;17(1):149-154. doi: 10.2217/fca-2020-0052. Epub 2020 Jul 6.
PubMed 32628045
Safdar B, Spatz ES, Dreyer RP, Beltrame JF, Lichtman JH, Spertus JA, Reynolds HR, Geda M, Bueno H, Dziura JD, Krumholz HM, D'Onofrio G. Presentation, Clinical Profile, and Prognosis of Young Patients With Myocardial Infarction With Nonobstructive Coronary Arteries (MINOCA): Results From the VIRGO Study. J Am Heart Assoc. 2018 Jun 28;7(13):e009174. doi: 10.1161/JAHA.118.009174.
PubMed 29954744
Grodzinsky A, Arnold SV, Gosch K, Spertus JA, Foody JM, Beltrame J, Maddox TM, Parashar S, Kosiborod M. Angina Frequency After Acute Myocardial Infarction In Patients Without Obstructive Coronary Artery Disease. Eur Heart J Qual Care Clin Outcomes. 2015;1(2):92-99. doi: 10.1093/ehjqcco/qcv014. Epub 2015 Jul 23.
PubMed 28239487
Planer D, Mehran R, Ohman EM, White HD, Newman JD, Xu K, Stone GW. Prognosis of patients with non-ST-segment-elevation myocardial infarction and nonobstructive coronary artery disease: propensity-matched analysis from the Acute Catheterization and Urgent Intervention Triage Strategy trial. Circ Cardiovasc Interv. 2014 Jun;7(3):285-93. doi: 10.1161/CIRCINTERVENTIONS.113.000606. Epub 2014 May 20.
PubMed 24847016
Jespersen L, Abildstrom SZ, Hvelplund A, Galatius S, Madsen JK, Pedersen F, Hojberg S, Prescott E. Symptoms of angina pectoris increase the probability of disability pension and premature exit from the workforce even in the absence of obstructive coronary artery disease. Eur Heart J. 2013 Nov;34(42):3294-303. doi: 10.1093/eurheartj/eht395. Epub 2013 Sep 26.
PubMed 24071763
Montone RA, Niccoli G, Fracassi F, Russo M, Gurgoglione F, Camma G, Lanza GA, Crea F. Patients with acute myocardial infarction and non-obstructive coronary arteries: safety and prognostic relevance of invasive coronary provocative tests. Eur Heart J. 2018 Jan 7;39(2):91-98. doi: 10.1093/eurheartj/ehx667.
PubMed 29228159
Montone RA, Niccoli G, Russo M, Giaccari M, Del Buono MG, Meucci MC, Gurgoglione F, Vergallo R, D'Amario D, Buffon A, Leone AM, Burzotta F, Aurigemma C, Trani C, Liuzzo G, Lanza GA, Crea F. Clinical, angiographic and echocardiographic correlates of epicardial and microvascular spasm in patients with myocardial ischaemia and non-obstructive coronary arteries. Clin Res Cardiol. 2020 Apr;109(4):435-443. doi: 10.1007/s00392-019-01523-w. Epub 2019 Jul 3.
PubMed 31270616
Crea F, Niccoli G. Myocardial Infarction With Nonobstructive Coronary Atherosclerosis: The Need for Precision Medicine. JACC Cardiovasc Imaging. 2019 Nov;12(11 Pt 1):2222-2224. doi: 10.1016/j.jcmg.2018.09.003. Epub 2018 Oct 17. No abstract available.
PubMed 30343094
Pasupathy S, Air T, Dreyer RP, Tavella R, Beltrame JF. Systematic review of patients presenting with suspected myocardial infarction and nonobstructive coronary arteries. Circulation. 2015 Mar 10;131(10):861-70. doi: 10.1161/CIRCULATIONAHA.114.011201. Epub 2015 Jan 13.
PubMed 25587100
Dastidar AG, Baritussio A, De Garate E, Drobni Z, Biglino G, Singhal P, Milano EG, Angelini GD, Dorman S, Strange J, Johnson T, Bucciarelli-Ducci C. Prognostic Role of CMR and Conventional Risk Factors in Myocardial Infarction With Nonobstructed Coronary Arteries. JACC Cardiovasc Imaging. 2019 Oct;12(10):1973-1982. doi: 10.1016/j.jcmg.2018.12.023. Epub 2019 Feb 13.
PubMed 30772224
Lindahl B, Baron T, Erlinge D, Hadziosmanovic N, Nordenskjold A, Gard A, Jernberg T. Medical Therapy for Secondary Prevention and Long-Term Outcome in Patients With Myocardial Infarction With Nonobstructive Coronary Artery Disease. Circulation. 2017 Apr 18;135(16):1481-1489. doi: 10.1161/CIRCULATIONAHA.116.026336. Epub 2017 Feb 8.
PubMed 28179398
Ford TJ, Stanley B, Good R, Rocchiccioli P, McEntegart M, Watkins S, Eteiba H, Shaukat A, Lindsay M, Robertson K, Hood S, McGeoch R, McDade R, Yii E, Sidik N, McCartney P, Corcoran D, Collison D, Rush C, McConnachie A, Touyz RM, Oldroyd KG, Berry C. Stratified Medical Therapy Using Invasive Coronary Function Testing in Angina: The CorMicA Trial. J Am Coll Cardiol. 2018 Dec 11;72(23 Pt A):2841-2855. doi: 10.1016/j.jacc.2018.09.006. Epub 2018 Sep 25.
PubMed 30266608
Ford TJ, Stanley B, Sidik N, Good R, Rocchiccioli P, McEntegart M, Watkins S, Eteiba H, Shaukat A, Lindsay M, Robertson K, Hood S, McGeoch R, McDade R, Yii E, McCartney P, Corcoran D, Collison D, Rush C, Sattar N, McConnachie A, Touyz RM, Oldroyd KG, Berry C. 1-Year Outcomes of Angina Management Guided by Invasive Coronary Function Testing (CorMicA). JACC Cardiovasc Interv. 2020 Jan 13;13(1):33-45. doi: 10.1016/j.jcin.2019.11.001. Epub 2019 Nov 11.
PubMed 31709984

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PROgnostic Value of Precision Medicine in Patients With Myocardial Infarction and Non-obStructive Coronary artEries: the PROMISE Trial.
ClinicalTrials.gov ID: NCT05122780
Acronym / sponsor ID: PROMISE / GR-2019-12370197
Conditions: Myocardial Infarction With Non-Obstructive Coronary Arteries
Keywords: MINOCA, coronary spasm, OCT
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 120 participants (actual)
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
Collaborators: Centro Cardiologico Monzino, IRCCS Policlinico S. Donato
Study start: 1 Jul 2021 (actual)
Primary completion: Jul 2025 (estimated)
Study completion: Jul 2025 (estimated)
First posted: 17 Nov 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study is a multicentre trial involving 3 centers: IRCCS Fondazione Policlinico Universitario A. Gemelli (Study Promoter), Centro Cardiologico Monzino IRCCS, IRCCS Policlinico San Donato.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Patients will be randomized 1:1 (using an online software available 24h/24h) to "precision medicine approach" vs "standard approach".

Arm	Type	Receives
"Precision medicine approach"	Active comparator	Procedure: Coronary angiography, Diagnostic Test: OCT imaging, Procedure: Percutaneous coronary intervention (PCI):, Diagnostic Test: Acetylcholine provocative test, Diagnostic Test: TT-Echocardiography, Diagnostic Test: TE/contrast echocardiography, Diagnostic Test: Cardiac magnetic resonance, Diagnostic Test: Circulating biomarkers, Drug: Antiplatelet Drug, Drug: Statin, Drug: Beta blocker, Drug: ACEi/ARB, Drug: CCB, Drug: Nitrates, Drug: AnticoagulantComprehensive diagnostic work-up with: * Coronary angiography and ventriculography in all patients * OCT at the time of coronary angiography in the cath-lab. * Acetylcholine provocative test (to assess the presence of coronary vasospasm) at the time of coronary angiography in the cath-lab. * TE-Echo and/or CE-Echo (if distal/microvascular embolization is suspected) * Blood sampling for circulating biomarkers and miRNA expression profile * Trans-thoracic echocardiography in all patients during the index hospitalization * CMR in all cases during the index hospitalization. Targeted pharmacological treatment specific for the underlying cause: * DAPT ± stent implantation (if required), statins, beta-blockers, ACEi/ARB (in case of evidence of plaque rupture/erosion) * CCB and/or nitrates (in case of documentation of coronary vasospasm) * Anticoagulation (in case of coronary embolism).
"Standard approach"	Other	Procedure: Coronary angiography, Diagnostic Test: TT-Echocardiography, Diagnostic Test: Cardiac magnetic resonance, Drug: Antiplatelet Drug, Drug: Statin, Drug: Beta blocker, Drug: ACEi/ARBRoutine diagnostic work-up with: * Coronary angiography and ventriculography * Transthoracic echocardiography in all patients during the index hospitalization * CMR with contrast media only if clinically indicated (i.e. to exclude myocarditis or takotsubo syndrome) Standard medical treatment with: * DAPT in all patients * Beta-blockers (if indicated by the clinical context, i.e. documentation of left ventricular ejection fraction <50%, tachycardia). * High intensity statins in all patients * ACEi/ARB (if clinically indicated).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Ability to give informed consent to the study
Age > 18y
MINOCA diagnosis, defined as:

Key exclusion criteria (7 listed)

Inability or limited capacity to give informed consent to the study
Age < 18 y
Pregnant and breast-feeding women or patients considering becoming pregnant during the study period will be excluded. For women of childbearing potential, the use of a highly effective contraceptive measure is required in order to be included in the study. "Highly effective contraceptive" is defined in accordance with the recommendations of the Clinical Trial Facilitation Group as a contraceptive measure with a failure rate of less than 1% per year (https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2020_09_HMA_CTFG_Contraception_guidance_Version_1.1_updated.pdf).
Alternate diagnosis for the clinical presentation (i.e. non-ischemic causes of myocardial injury such as sepsis, pulmonary embolism, valve disease, hypertrophic cardiomyopathy and myocarditis). Also patients presenting with Takotsubo syndrome will be excluded.
Contraindication to contrast-enhanced CMR, eg, severe renal dysfunction (glomerular filtration rate <30 mL/min), non-CMR-compatible pacemaker or defibrillator.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Coronary angiographycoronary angiography will be performed via the transradial or transfemoral approach with the use of a 6F sheath. Coronary angiography will be performed within 90 minutes from hospital admission in patients presenting with persistent ST-segment elevation, and within 48 hours in patients presenting with non-ST-segment elevation. Unfractionated heparin (initial weight-adjusted intravenous bolus of 60 IU/Kg, with repeat boluses to achieve an activated clotting time of 250 to 300 seconds) was administered in all patients. If evidence of plaque rupture	Procedure or surgery	"Precision medicine approach", "Standard approach"
OCT imagingOCT imaging will be performed in the culprit artery in all patients randomized to the "precision medicine approach". A 0.014-inch guidewire will be placed distally in the target vessel and an intracoronary injection of 200 µg of nitroglycerine will be performed. Frequency domain OCT (FD-OCT) images are acquired by a commercially available system (C7 System, LightLab Imaging Inc/ St Jude Medical, Westford, MA) connected to an OCT catheter (C7 Dragonfly; LightLab Imaging Inc/ St Jude Medical, Westford, MA), which was advanced to the culprit lesion. The FD-OCT run will be performed using the integrated automated pullback device at 20 mm/s. During image acquisition, coronary blood flow will be replaced by continuous flushing of contrast media directly from the guiding catheter at a rate of 4 ml/s with a power injector in order to create a virtually blood-free environment.	Diagnostic test	"Precision medicine approach"
Percutaneous coronary intervention (PCI):PCI with stent implantation will be considered in selected cases with evidences of plaque rupture	Procedure or surgery	"Precision medicine approach"
Acetylcholine provocative testACh will be administered in a stepwise manner into the left coronary artery (LCA) (20-200 μg) or into the right coronary artery (RCA) (20-50 μg) over a period of 3 min with a 2-3 min interval between injections. Coronary angiography will be performed 1 min after each injection of these agents and/or when chest pain and/or ischaemic ECG shifts were observed. The decision of testing with provocative test LCA or RCA as first will be left to the discretion of the physicians; both LCA and RCA will be tested if the first test was negative. Angiographic responses during the provocative test will be assessed in multiple orthogonal views in order to detect the most severe narrowing and/or analysed by using computerized quantitative coronary angiography (QCA-CMS, Version 6.0, Medis-Software, Leiden, The Netherlands).	Diagnostic test	"Precision medicine approach"
TT-EchocardiographyTT-Echo will be used to calculate left and right ventricular and atrial dimensions, left and right ventricular systolic function, transmitral flow Doppler spectra, mitral and tricuspidal valve annulus tissue Doppler spectra, ejection time and stroke volume, inferior vena cava, aorta and pulmonary artery diameters and Doppler spectra, according to the recommendations of the American Society of Echocardiography.	Diagnostic test	"Precision medicine approach", "Standard approach"
TE/contrast echocardiographyIn patients with angiographic evidence or suspicion of distal microembolization, TE-Echo consisting of an echocardiographic probe inserted in to the oesophagus will be used to detect a hidden cardioembolic source (i.e. left atrial thrombus); in patients with suspected left ventricular source of cardioembolism, contrast echocardiography consisting of a 0.3ml solution of SONOVUE will be used.	Diagnostic test	"Precision medicine approach"
Cardiac magnetic resonanceCMR will be performed during hospital stay on a 1.5-T system equipped with a 32-channel cardiac coil. Patients underwent conventional CMR including cine, T2-weighted, first pass perfusion, and conventional breath-held late gadolinium enhancement (LGE).	Diagnostic test	"Precision medicine approach", "Standard approach"
Circulating biomarkersBlood sampling for circulating biomarkers and miRNA expression profile at the time or within 12 hours of coronary angiography. Blood sampling will be processed and analysed in the research laboratory of the Department of Cardiovascular Science. Biological aliquots will be preserved at XBiogem Biobank at Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome (see section 33).	Diagnostic test	"Precision medicine approach"
Antiplatelet Drugacetylsalicylic acid (loading dose 250mg intravenously followed by 75mg orally) + P2Y12 receptor inhibitor (i.e. Clopidogrel, 300 or 600mg loading dose orally, followed by 75 mg orally daily).	Drug	"Precision medicine approach", "Standard approach"
Statini.e. atorvastatin; dosages titrated on the patient's clinical characteristics	Drug	"Precision medicine approach", "Standard approach"
Beta blockeri.e. bisoprolol; dosages titrated on blood pressure, ECG, heart rate	Drug	"Precision medicine approach", "Standard approach"
ACEi/ARBi.e. ramipril; dosages titrated on blood pressure, ECG, heart rate	Drug	"Precision medicine approach", "Standard approach"
CCBi.e. diltiazem; dosages titrated on blood pressure, ECG, heart rate	Drug	"Precision medicine approach"
Nitratesi.e. nitroglycerine; dosages titrated on blood pressure, ECG, heart rate	Drug	"Precision medicine approach"
Anticoagulanti.e. warfarin; the selection of the anticoagulant agent will be based on the clinical scenario, contraindications etc	Drug	"Precision medicine approach"

Primary outcome

Angina status
Time frame: 1-year follow-up
Angina status will be evaluated using the single-item "angina stability scale" and the two-item "angina frequence scale" of the Seattle Angina Questionnaire (SAQ). Scores are calculated by summing items within a dimension and transforming it to a 0-100 scale, where 0 is the worst and 100 the best possible level of health. * To reduce the risk of detection and performance bias, a team of 2 cardiologists blinded to group allocation and belonging to an external cardiology unit will submit and collate the questionnaires from study participants.
eattle Angina Questionnaire (SAQ)
Time frame: 1-year follow-up
Quality of life will be evaluated using the nine-item scale of "physical limitations scale", the three-item "treatment satisfaction scale" and two-item "disease perception scale" of the Seattle Angina Questionnaire (SAQ). Scores are calculated by summing items within a dimension and transforming it to a 0-100 scale, where 0 is the worst and 100 the best possible level of health. * To reduce the risk of detection and performance bias, a team of 2 cardiologists blinded to group allocation and belonging to an external cardiology unit will submit and collate the questionnaires from study participants.

15 secondary outcomes

Rates of major adverse cardiovascular events
Time frame: 1-year follow-up
Healthcare primary related-costs
Time frame: 1-year follow-up
Healthcare secondary related-costs
Time frame: 1-year follow-up
Healthcare secondary related-costs
Time frame: 1-year follow-up
Ability of different circulating biomarkers as diagnostic biomarker and stratification tool for specific causes of MINOCA.
Time frame: during index hospitalization (at the time or within 12 hours of coronary angiography)
Ability of different circulating biomarkers as diagnostic biomarker and stratification tool for specific causes of MINOCA.
Time frame: during index hospitalization (at the time or within 12 hours of coronary angiography)
Ability of different circulating biomarkers as diagnostic biomarker and stratification tool for specific causes of MINOCA.
Time frame: during index hospitalization (at the time or within 12 hours of coronary angiography)
Ability of different circulating biomarkers as diagnostic biomarker and stratification tool for specific causes of MINOCA.
Time frame: during index hospitalization (at the time or within 12 hours of coronary angiography)
Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.
Time frame: from day 3 to day 7 from the acute coronary event
Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.
Time frame: from day 3 to day 7 from the acute coronary event
Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.
Time frame: from day 3 to day 7 from the acute coronary event
Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.
Time frame: from day 3 to day 7 from the acute coronary event
Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.
Time frame: from day 3 to day 7 from the acute coronary event
Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.
Time frame: from day 3 to day 7 from the acute coronary event
Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.
Time frame: from day 3 to day 7 from the acute coronary event

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
Background: PubMed 30913893Tamis-Holland JE, Jneid H, Reynolds HR, Agewall S, Brilakis ES, Brown TM, Lerman A, Cushman M, Kumbhani DJ, Arslanian-Engoren C, Bolger AF, Beltrame JF; American Heart Association Interventional Cardiovascular Care Committee of the Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; and Council on Quality of Care and Outcomes Research. Contemporary Diagnosis and Management of Patients With Myocardial Infarction in the Absence of Obstructive Coronary Artery Disease: A Scientific Statement From the American Heart Association. Circulation. 2019 Apr 30;139(18):e891-e908. doi: 10.1161/CIR.0000000000000670.
Background: PubMed 25526726Niccoli G, Scalone G, Crea F. Acute myocardial infarction with no obstructive coronary atherosclerosis: mechanisms and management. Eur Heart J. 2015 Feb 21;36(8):475-81. doi: 10.1093/eurheartj/ehu469. Epub 2014 Dec 18.
Background: PubMed 32628045Del Buono MG, Montone RA, Iannaccone G, Meucci MC, Rinaldi R, D'Amario D, Niccoli G. Diagnostic work-up and therapeutic implications in MINOCA: need for a personalized approach. Future Cardiol. 2021 Jan;17(1):149-154. doi: 10.2217/fca-2020-0052. Epub 2020 Jul 6.
Background: PubMed 29954744Safdar B, Spatz ES, Dreyer RP, Beltrame JF, Lichtman JH, Spertus JA, Reynolds HR, Geda M, Bueno H, Dziura JD, Krumholz HM, D'Onofrio G. Presentation, Clinical Profile, and Prognosis of Young Patients With Myocardial Infarction With Nonobstructive Coronary Arteries (MINOCA): Results From the VIRGO Study. J Am Heart Assoc. 2018 Jun 28;7(13):e009174. doi: 10.1161/JAHA.118.009174.
Background: PubMed 28239487Grodzinsky A, Arnold SV, Gosch K, Spertus JA, Foody JM, Beltrame J, Maddox TM, Parashar S, Kosiborod M. Angina Frequency After Acute Myocardial Infarction In Patients Without Obstructive Coronary Artery Disease. Eur Heart J Qual Care Clin Outcomes. 2015;1(2):92-99. doi: 10.1093/ehjqcco/qcv014. Epub 2015 Jul 23.
Background: PubMed 24847016Planer D, Mehran R, Ohman EM, White HD, Newman JD, Xu K, Stone GW. Prognosis of patients with non-ST-segment-elevation myocardial infarction and nonobstructive coronary artery disease: propensity-matched analysis from the Acute Catheterization and Urgent Intervention Triage Strategy trial. Circ Cardiovasc Interv. 2014 Jun;7(3):285-93. doi: 10.1161/CIRCINTERVENTIONS.113.000606. Epub 2014 May 20.
Background: PubMed 24071763Jespersen L, Abildstrom SZ, Hvelplund A, Galatius S, Madsen JK, Pedersen F, Hojberg S, Prescott E. Symptoms of angina pectoris increase the probability of disability pension and premature exit from the workforce even in the absence of obstructive coronary artery disease. Eur Heart J. 2013 Nov;34(42):3294-303. doi: 10.1093/eurheartj/eht395. Epub 2013 Sep 26.
Background: PubMed 29228159Montone RA, Niccoli G, Fracassi F, Russo M, Gurgoglione F, Camma G, Lanza GA, Crea F. Patients with acute myocardial infarction and non-obstructive coronary arteries: safety and prognostic relevance of invasive coronary provocative tests. Eur Heart J. 2018 Jan 7;39(2):91-98. doi: 10.1093/eurheartj/ehx667.
Background: PubMed 31270616Montone RA, Niccoli G, Russo M, Giaccari M, Del Buono MG, Meucci MC, Gurgoglione F, Vergallo R, D'Amario D, Buffon A, Leone AM, Burzotta F, Aurigemma C, Trani C, Liuzzo G, Lanza GA, Crea F. Clinical, angiographic and echocardiographic correlates of epicardial and microvascular spasm in patients with myocardial ischaemia and non-obstructive coronary arteries. Clin Res Cardiol. 2020 Apr;109(4):435-443. doi: 10.1007/s00392-019-01523-w. Epub 2019 Jul 3.
Background: PubMed 30343094Crea F, Niccoli G. Myocardial Infarction With Nonobstructive Coronary Atherosclerosis: The Need for Precision Medicine. JACC Cardiovasc Imaging. 2019 Nov;12(11 Pt 1):2222-2224. doi: 10.1016/j.jcmg.2018.09.003. Epub 2018 Oct 17. No abstract available.
Background: PubMed 25587100Pasupathy S, Air T, Dreyer RP, Tavella R, Beltrame JF. Systematic review of patients presenting with suspected myocardial infarction and nonobstructive coronary arteries. Circulation. 2015 Mar 10;131(10):861-70. doi: 10.1161/CIRCULATIONAHA.114.011201. Epub 2015 Jan 13.
Background: PubMed 30772224Dastidar AG, Baritussio A, De Garate E, Drobni Z, Biglino G, Singhal P, Milano EG, Angelini GD, Dorman S, Strange J, Johnson T, Bucciarelli-Ducci C. Prognostic Role of CMR and Conventional Risk Factors in Myocardial Infarction With Nonobstructed Coronary Arteries. JACC Cardiovasc Imaging. 2019 Oct;12(10):1973-1982. doi: 10.1016/j.jcmg.2018.12.023. Epub 2019 Feb 13.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nicola Cosentino, MD principal investigator

Centro Cardiologico Monzino

Riccardo Gorla, MD principal investigator

IRCCS Policlinico S. Donato

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Angina status (time frame: 1-year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05122780, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.