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ANOCA - Angina With Non-obstructive Coronary ArteriesANOCA-UYNCT07593157

Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women

A study testing Invasive Coronary Functional and Morphological Assessment and Pharmacological treatment will be individualized according to the invasive coronary phenotype identified. Treatment may include antianginal therapy, vasodilator therapy, endothelial function-targeted in people with ANOCA - Angina With Non-obstructive Coronary Arteries and Coronary Microvascular Dysfunction (CMD), run by Hospital de Clínicas Dr. Manuel Quintela at 1 site in Uruguay.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This prospective single-center interventional study will include women with angina and non-obstructive coronary arteries. Participants will undergo a standardized invasive coronary assessment combining coronary physiology, acetylcholine provocation testing, and optical coherence tomography. Read more about this study

Who is it for?
Ages 35 to 75 years, women only
What is being tested?
Invasive Coronary Functional and Morphological Assessment and Pharmacological treatment will be individualized according to the invasive coronary phenotype identified. Treatment may include antianginal therapy, vasodilator therapy, endothelial function-targeted
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUruguay
Study dates
15 May 2026to 30 Apr 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 35 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female participants aged 35 to 75 years.
  • Symptoms compatible with stable angina or suspected myocardial ischemia.
  • Non-obstructive coronary arteries, defined as absence of angiographic stenosis greater than or equal to 50%.
  • Ability to undergo invasive coronary assessment and clinical follow-up.
  • Written informed consent.

Who cannot join

  • Significant structural heart disease.
  • Severe left ventricular systolic dysfunction, defined as left ventricular ejection fraction <40%.
  • Clinically relevant contraindication to adenosine or acetylcholine, including severe asthma, untreated high-grade atrioventricular block, or known hypersensitivity.
  • Active oncological disease or life expectancy less than 12 months.
  • Inability to complete the diagnostic or therapeutic study protocol.
  • Participation in another clinical study that could interfere with the present protocol.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rafael Mila, MD contact

+59824871515 ext. 9

r1000a@gmail.com

Victor Dayan, MD, PhD contact

+5989924871515 ext. 9

victordayan24@gmail.com

Uruguay1 site, 1 recruiting

  • Hospital de Clínicas Dr. Manuel Quintela

    Montevideo, Montevideo Department, 11600

    Rafael Mila, MD, +59824875201, cencar@hc.edu.uy

    Victor Dayan, MD, PhD, +59824875201, cencar@hc.edu.uy

    Recruiting

Other trials in Uruguay

About this study

Official title: Invasive Functional and Morphological Coronary Assessment Followed by Phenotype-Guided Multidisciplinary Treatment in Women With Angina and Non-Obstructive Coronary Arteries: A Prospective Single-Center Interventional Study

This prospective single-center interventional study will include women with angina and non-obstructive coronary arteries. Participants will undergo a standardized invasive coronary assessment combining coronary physiology, acetylcholine provocation testing, and optical coherence tomography. The diagnostic protocol will identify functional and morphological mechanisms of angina, including microvascular dysfunction, epicardial vasospasm, microvascular spasm, endothelial dysfunction, functional epicardial disease, combined mechanisms, or normal coronary physiology.

Based on the identified phenotype, participants will receive individualized multidisciplinary treatment, including targeted pharmacological therapy, adapted cardiovascular rehabilitation, and psycho-emotional support when indicated. Clinical follow-up will be performed at 1, 6, and 12 months to assess angina symptoms, quality of life, functional capacity, adherence to treatment, and cardiovascular events.

Read the detailed description

Angina with non-obstructive coronary arteries (ANOCA) is a prevalent and frequently underdiagnosed clinical condition, particularly in women. Although obstructive epicardial coronary artery disease is absent, symptoms may be related to coronary microvascular dysfunction, epicardial or microvascular vasospasm, endothelial dysfunction, non-obstructive atherosclerotic plaque, myocardial bridging, or combined mechanisms. In routine clinical practice, many patients remain without a precise pathophysiological diagnosis after conventional angiography.

This study will evaluate a structured diagnostic and therapeutic pathway for women with ANOCA at a single academic cardiovascular center in Uruguay. Eligible participants will undergo an invasive coronary assessment performed during cardiac catheterization. The protocol will include angiographic confirmation of non-obstructive coronary arteries, invasive coronary physiology assessment, acetylcholine provocation testing for coronary vasomotor disorders, and optical coherence tomography for intracoronary morphological assessment.

The invasive findings will be integrated to classify participants according to their predominant functional and/or morphological phenotype. Potential phenotypes include coronary microvascular dysfunction, epicardial vasospasm, microvascular spasm, endothelial dysfunction, functional epicardial disease, non-obstructive plaque-related abnormalities, combined mechanisms, or normal invasive coronary physiology.

After phenotyping, participants will receive an individualized treatment plan according to the identified mechanism. This may include targeted pharmacological therapy, cardiovascular risk factor optimization, adapted cardiovascular rehabilitation, and structured psycho-emotional support when clinically indicated. The therapeutic strategy will be determined by the treating clinical team according to the study protocol and current evidence-based recommendations.

Participants will be followed for 12 months after the invasive assessment. Follow-up visits will assess angina symptoms, health-related quality of life, functional capacity, treatment adherence, adverse events, and cardiovascular outcomes. The study aims to generate local evidence on the feasibility and clinical utility of a phenotype-guided approach for women with ANOCA and to support the development of a multidisciplinary reference pathway for this condition in Uruguay.

Being tested
Invasive Coronary Functional and Morphological Assessment, Pharmacological treatment will be individualized according to the invasive coronary phenotype identified. Treatment may include antianginal therapy, vasodilator therapy, endothelial function-targeted
Keywords
Angina with non-obstructive coronary arteries, ANOCA, INOCA, Vasospastic angina, Coronary Microvascular Dysfunction
Medical subject headings
Angina Pectoris, Variant

What participants receive

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

  • Invasive Coronary Functional and Morphological AssessmentProcedure or surgery

    Participants will undergo invasive coronary assessment including coronary physiology measurements, acetylcholine provocation testing, and optical coherence tomography to identify functional and morphological mechanisms of angina with non-obstructive coronary arteries.

  • Pharmacological treatment will be individualized according to the invasive coronary phenotype identified. Treatment may include antianginal therapy, vasodilator therapy, endothelial function-targetedDrug

    Pharmacological treatment will be individualized according to the invasive coronary phenotype identified. Treatment may include antianginal therapy, vasodilator therapy, endothelial function-targeted therapy, cardiovascular risk factor optimization, or revascularization evaluation when clinically indicated.

Study groups in NCT07593157
Study groupRoleWhat they receive
Phenotype-Guided Diagnostic and Therapeutic StrategyExperimentalParticipants will undergo a standardized invasive coronary assessment to identify functional and morphological mechanisms of angina with non-obstructive coronary arteries. Based on the identified phenotype, participants will receive individualized treatment including targeted pharmacological therapy, adapted cardiovascular rehabilitation, and psycho-emotional support when clinically indicated.
Receives: Procedure: Invasive Coronary Functional and Morphological Assessment; Drug: Pharmacological treatment will be individualized according to the invasive coronary phenotype identified. Treatment may include antianginal therapy, vasodilator therapy, endothelial function-targeted

What is being measured

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

  1. Change in Angina-Related Health Status Assessed by the Seattle Angina Questionnaire-7

    Change in Seattle Angina Questionnaire-7 score from baseline to 12-month follow-up after invasive coronary phenotyping and phenotype-guided multidisciplinary treatment. The Seattle Angina Questionnaire-7 is a 7-item patient-reported outcome measure assessing angina-related health status. Scores range from 0 to 100, with higher scores indicating better angina-related health status and fewer symptoms.

    Measured: Baseline to 12 months

Secondary outcomes (9)

  1. Change in Health-Related Quality of Life Assessed by the EuroQol 5-Dimension 5-Level Visual Analog Scale

    Change in EuroQol 5-Dimension 5-Level Visual Analog Scale score from baseline to 12-month follow-up. The EuroQol 5-Dimension 5-Level Visual Analog Scale is a patient-reported measure of overall health status. Scores range from 0 to 100, with higher scores indicating better self-reported health.

    Measured: Baseline to 12 months

  2. Change in Functional Capacity

    Change in functional capacity assessed by six-minute walk test distance or exercise testing parameters, according to the local study protocol.

    Measured: Baseline to 12 months

  3. Prevalence of Invasive Coronary Functional Phenotypes

    Proportion of participants classified as having coronary microvascular dysfunction, epicardial vasospasm, microvascular spasm, endothelial dysfunction, functional epicardial disease, combined mechanisms, or normal invasive coronary physiology.

    Measured: At index invasive coronary procedure

  4. Prevalence of Coronary Morphological Abnormalities Assessed by Optical Coherence Tomography

    Proportion of participants with non-obstructive atherosclerotic plaque, plaque rupture, plaque erosion, thin-cap fibroatheroma, macrophage accumulation, positive remodeling, myocardial bridging, spontaneous coronary artery dissection, or other optical coherence tomography findings.

    Measured: At index invasive coronary procedure

  5. Change in Perceived Stress Assessed by the Perceived Stress Scale-4

    Change in Perceived Stress Scale-4 score from baseline to 6-month and 12-month follow-up. The Perceived Stress Scale-4 is a 4-item patient-reported measure of perceived stress during the previous month. Total scores range from 0 to 16, with higher scores indicating greater perceived stress and a worse outcome.

    Measured: Baseline to 6 and 12 months

  6. Medication Adherence Assessed by the Modified Morisky-Green-Levine Questionnaire

    Medication adherence will be assessed using the modified Morisky-Green-Levine questionnaire at 1, 6, and 12 months. The modified Morisky-Green-Levine questionnaire is a patient-reported measure of medication adherence. Scores range from 0 to 4, with higher scores indicating better medication adherence.

    Measured: 1, 6, and 12 months

  7. Major Adverse Cardiovascular Events

    Composite of death, myocardial infarction, hospitalization for cardiovascular causes, or coronary revascularization during follow-up.

    Measured: Baseline to 12 months

  8. Adherence to Cardiovascular Rehabilitation Assessed by Session Completion Rate

    Adherence to cardiovascular rehabilitation will be assessed at 1, 6, and 12 months as the percentage of prescribed rehabilitation sessions completed. Higher percentages indicate better adherence. Adherence will be defined as completion of at least 75% of prescribed sessions.

    Measured: During the 12-week cardiovascular rehabilitation program.

  9. Adherence to Psycho-Emotional Support Assessed by Session Completion Rate

    Adherence to psycho-emotional support will be assessed at 1, 6, and 12 months as the percentage of prescribed sessions completed among participants for whom this intervention is clinically indicated. Higher percentages indicate better adherence. Adherence will be defined as completion of at least 75% of prescribed sessions.

    Measured: 1, 6, and 12 months

Timeline

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

  1. First posted18 May 2026
  2. Study start15 May 2026
  3. Primary completion30 Apr 2029 (estimated)
  4. Study completion30 Apr 2029 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All participants will undergo the same structured diagnostic and therapeutic pathway. The intervention consists of invasive coronary phenotyping followed by individualized treatment according to the functional and/or morphological mechanism identified. There is no randomization and no comparator arm.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07593157
Sponsor's protocol ID
FMV_1_2025_1_186667
Other IDs
FMV_1_2025_1_186667
Acronym
ANOCA-UY
Status last verified
Jul 2026
First submitted
10 May 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The individual participant data sharing plan is currently undecided and will depend on institutional policies, ethics committee requirements, participant consent, and applicable data protection regulations.

Publications

  • Mila R, Albistur J, Valdez M, Loza G, Torrado J, Bachini J, Murguia S, Acquistapace F, Nobile N, Briano V, Niggemeyer A, Trujillo P, Niell N, Duran A, Alfonso F, Dayan V. "A stratified pathway to stent-free reperfusion: Selecting suitable patients in ST-elevation myocardial infarction". Cardiovasc Revasc Med. 2025 Jun;75:90-97. doi: 10.1016/j.carrev.2024.09.001. Epub 2024 Sep 14.

    PubMed 39306485

  • Albistur S, Torrado J, Niell N, Mila R. Microvascular dysfunction following deferred stenting strategy in ST-segment elevation myocardial infarction: a case report. Eur Heart J Case Rep. 2023 Nov 14;7(11):ytad564. doi: 10.1093/ehjcr/ytad564. eCollection 2023 Nov.

    PubMed 38034941

  • Larsen AI, Saeland C, Vegsundvag J, Skadberg MS, Nilsen J, Butt N, Ushakova A, Valborgland T, Munk PS, Isaksen K. Aerobic high-intensity interval exercise training in patients with angina and no obstructive coronary artery disease: feasibility and physiological effects. Eur Heart J Open. 2023 Mar 22;3(2):oead030. doi: 10.1093/ehjopen/oead030. eCollection 2023 Mar.

    PubMed 37113515

  • Hokimoto S, Kaikita K, Yasuda S, Tsujita K, Ishihara M, Matoba T, Matsuzawa Y, Mitsutake Y, Mitani Y, Murohara T, Noda T, Node K, Noguchi T, Suzuki H, Takahashi J, Tanabe Y, Tanaka A, Tanaka N, Teragawa H, Yasu T, Yoshimura M, Asaumi Y, Godo S, Ikenaga H, Imanaka T, Ishibashi K, Ishii M, Ishihara T, Matsuura Y, Miura H, Nakano Y, Ogawa T, Shiroto T, Soejima H, Takagi R, Tanaka A, Tanaka A, Taruya A, Tsuda E, Wakabayashi K, Yokoi K, Minamino T, Nakagawa Y, Sueda S, Shimokawa H, Ogawa H; Japanese Circulation Society and Japanese Association of Cardiovascular Intervention and Therapeutics and Japanese College of Cardiology Joint Working Group. JCS/CVIT/JCC 2023 Guideline Focused Update on Diagnosis and Treatment of Vasospastic Angina (Coronary Spastic Angina) and Coronary Microvascular Dysfunction. Circ J. 2023 May 25;87(6):879-936. doi: 10.1253/circj.CJ-22-0779. Epub 2023 Apr 6. No abstract available.

    PubMed 36908169

  • Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.

    PubMed 39210710

  • Smilowitz NR, Prasad M, Widmer RJ, Toleva O, Quesada O, Sutton NR, Lerman A, Reynolds HR, Kesarwani M, Savage MP, Sweeny JM, Janaszek KB, Barseghian El-Farra A, Holoshitz N, Park K, Albadri A, Blair JA, Jeremias A, Kearney KE, Kobayashi Y, Miner SES, Samuels BA, Shah SM, Taqueti VR, Wei J, Fearon WF, Moses JW, Henry TD, Tremmel JA; Microvascular Network (MVN). Comprehensive Management of ANOCA, Part 2-Program Development, Treatment, and Research Initiatives: JACC State-of-the-Art Review. J Am Coll Cardiol. 2023 Sep 19;82(12):1264-1279. doi: 10.1016/j.jacc.2023.06.044.

    PubMed 37704316

  • Samuels BA, Shah SM, Widmer RJ, Kobayashi Y, Miner SES, Taqueti VR, Jeremias A, Albadri A, Blair JA, Kearney KE, Wei J, Park K, Barseghian El-Farra A, Holoshitz N, Janaszek KB, Kesarwani M, Lerman A, Prasad M, Quesada O, Reynolds HR, Savage MP, Smilowitz NR, Sutton NR, Sweeny JM, Toleva O, Henry TD, Moses JW, Fearon WF, Tremmel JA; Microvascular Network (MVN). Comprehensive Management of ANOCA, Part 1-Definition, Patient Population, and Diagnosis: JACC State-of-the-Art Review. J Am Coll Cardiol. 2023 Sep 19;82(12):1245-1263. doi: 10.1016/j.jacc.2023.06.043.

    PubMed 37704315

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Invasive Coronary Functional and Morphological Assessment and Pharmacological treatment will be individualized according to the invasive coronary phenotype identified. Treatment may include antianginal therapy, vasodilator therapy, endothelial function-targeted in people with ANOCA - Angina With Non-obstructive Coronary Arteries and Coronary Microvascular Dysfunction (CMD), run by Hospital de Clínicas Dr. Manuel Quintela at 1 site in Uruguay.

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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uruguay. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Rafael Mila, MD (+59824871515 ext. 9, r1000a@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Angina-Related Health Status Assessed by the Seattle Angina Questionnaire-7 (time frame: Baseline to 12 months). 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 NCT07593157, which also lists 8 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 4 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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