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Coronary Artery DiseaseNCT04475094

Impact of Coronary Artery Stenting on Quantitative Myocardial Blood Flow and Health Status

An observational study of Coronary Artery Disease, run by Cardiovascular Imaging Technologies at 1 site in United States.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

We propose to perform PET MPI studies in patients before and after stenting to evaluate changes (or lack thereof) in MBFR and how that is associated with changes (or lack thereof) in symptoms, functional status and quality of life. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Rubidium-82, Seattle Angina Questionnaire-7 and Rose Dyspnea Scale
How many people
75 participants
Where
1 siteUnited States
Study dates
23 Dec 2019to 31 Dec 2021
Phase
Observational
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients will have had a clinically-indicated PET revealing at least one reversible perfusion defect followed by a research-indicated cardiac PET study between 3 and 8 weeks post-successful coronary artery stenting.

Who may be able to join

  • The index clinically-indicated rest/regadenoson stress myocardial perfusion PET study shows at least one reversible perfusion defect; and
  • The MBFR measurement meets quality control criteria for accuracy; and
  • The patient has completed a baseline SAQ-7 and RDS survey with a SAQ-7 Angina Frequency Score <100 (indicating the occurrence of at least some angina symptoms over the past 4 weeks); and
  • The patient has undergone a successful coronary artery stenting within 60 days after the PET scan without a significant change in clinical condition between the time of baseline PET MPI test and PCI; and 5. The patient agrees to undergo a second PET scan 3-6 weeks after coronary artery stenting and to complete a second SAQ-7 and RDS survey.

Who cannot join

  • EF <40%
  • Significant aortic stenosis/regurgitation
  • Significant Mitral stenosis/regurgitation)
  • Prior CABG
  • Poor quality base line PET study due one or more technical challenges (e.g. patient motion, imprecise registration of CT and emission data, flows that violate quality criteria, lack of flow augmentation suggestive of an A2A antagonist)

Trial locations and contacts

1 site in 1 country.

Krishna Patel, MD contact

216-776-2196

kpatel@saint-lukes.org

Staci Courter, MA contact

816-531-2842 ext. 107

scourter@cvit.com

United States1 site, 1 recruiting

  • Saint Luke's Hospital Imaging Center

    Kansas City, Missouri, 64111

    Timothy M Bateman, MD, 816-531-2842 ext. 102, tbateman@cvit.com

    Staci A Courter, MA, 816-751-8542 ext. 107, scourter@cvit.com

    Recruiting

Other trials in United States

About this study

We propose to perform PET MPI studies in patients before and after stenting to evaluate changes (or lack thereof) in MBFR and how that is associated with changes (or lack thereof) in symptoms, functional status and quality of life. This will help to understand the role of MBFR in patient selection for coronary angiography and stenting.

Read the detailed description

Myocardial perfusion imaging (MPI) has a well-established role in diagnosis, risk stratification and prognostication in patients with suspected or known coronary artery disease (CAD)(1,2). As the current health-care landscape moves towards rewarding value, there is an increased urgency for determining the role of imaging tests in improving patient-centered outcomes (3-5). Traditionally, the cardiac imaging community has focused on studying "hard outcomes" such as cardiac morbidity and mortality, with relatively little attention on patient-centered health status outcomes (e.g. symptoms, function and quality of life).

While Single Photon Emission Computed Tomography (SPECT) has been a myocardial perfusion imaging (MPI) mainstay for decades, use of Positron Emission Tomography (PET) MPI has been increasing as it offers superior spatial resolution, lower radiation exposure, higher diagnostic accuracy, shorter acquisition times and quantification of myocardial blood flow reserve (MBFR) (6-9). MBFR integrates the hemodynamic effects of microvascular dysfunction, diffuse atherosclerotic disease and epicardial stenosis on myocardial tissue perfusion, and as such is more likely to correlate with patient's anginal symptoms, functional status and quality of life (10,11). MBFR measured by PET MPI has been shown to provide independent and incremental prognostic value for major adverse cardiac events beyond perfusion defect analysis, but has not been evaluated for its association with symptoms, function and quality of life (although in a post-hoc analysis of 171 patients with known CAD undergoing PET MPI enrolled in the ASPIRE study at our center, higher MBFR was significantly associated with lower anginal burden as measured by the Seattle Angina Questionnaire (SAQ; unpublished data, being presented at ASNC 2018)) (8,10,12-15). Among 329 patients, Taqueti et al demonstrated that patients with low global MBFR were less likely to require subsequent heart failure hospitalizations and cardiac deaths if treated with early revascularization with bypass surgery, but not percutaneous coronary intervention (PCI), as compared with medical management; however the low number of events and the small sample size were major limiting factors (10). More recently, among 12,594 patients undergoing PET MPI, we demonstrated that MBFR <1.8 may help identify patients with a survival benefit from early revascularization within 90 days of the index MPI test. (unpublished data, being presented at AHA 2018). In a sub-study of the PACIFIC study, Driessen et al showed strong correlation of change in MBFR post revascularization with change in FFR; providing further support for non-invasively measured MBFR as a potential measure to target intervention, similar to FFR, which needs invasive measurement on coronary angiography (16).

To further elucidate the mechanism of action by which MBFR could be used to target management for ischemic heart disease, we propose a study of serial PET MPI in 75 patients undergoing coronary stenting to evaluate the association of changes in MBFR with changes in patients' health status. About a quarter to half of stable CAD patients treated with PCI continue to have angina and poor quality of life after stenting (17-19) This may be because stenting is only directed at epicardial stenoses, while many patients have concomitant microvascular disease. While there has been some data where serial PET MPI studies have been used to look at changes in perfusion defect sizes and flows with anti-ischemic medications and statins (20-24) it is not known whether these changes are associated with improved outcomes. We propose to perform PET MPI studies in patients before and after stenting to evaluate changes (or lack thereof) in MBFR and how that is associated with changes (or lack thereof) in symptoms, functional status and quality of life. This will help to understand the role of MBFR in patient selection for coronary angiography and stenting.

Being tested
Rubidium-82, Seattle Angina Questionnaire-7, Rose Dyspnea Scale
Keywords
Myocardial Blood Flow
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • Rubidium-82Drug

    Also called Myocardial Perfusion PET

    Consented subjects will undergo a rest/regadenoson stress myocardial perfusion PET study.

  • Seattle Angina Questionnaire-7Behavioural

    Consented subjects will complete a SAQ-7.

  • Rose Dyspnea ScaleBehavioural

    Consented subjects will complete a RDS.

Study groups in NCT04475094
Study groupRoleWhat they receive
COHORTAll patients will have had a clinically-indicated PET revealing at least one reversible perfusion defect followed by a research-indicated cardiac PET study between 3 and 8 weeks post-successful coronary artery stenting.
Receives: Drug: Rubidium-82; Behavioral: Seattle Angina Questionnaire-7; Behavioral: Rose Dyspnea Scale

What is being measured

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

  1. Change in SAQ-7 Angina Frequency

    The primary study objective is to estimate the association of change from baseline in MBFR with SAQ-7 Angina Frequency scores, adjusting for baseline MBFR, baseline SAQ and other patient factors.

    Measured: 3-8 weeks

  2. Change in MBFR

    Secondary objective is to estimate the association of change in MBFR with adjusted SAQ-7 Physical Limitation, Quality of Life and Summary scores and Rose Dyspnea Scores (RDS).

    Measured: 3-8 weeks

  3. Extent of Epicaridal Stenoses

    Exploratory objectives include estimating the association of the extent of epicardial stenoses (vs. microvascular disease) at baseline with post-stent MBFR, SAQ-7 and RDS scores, adjusting for baseline.

    Measured: 3-8 weeks

Timeline

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

  1. First posted17 Jul 2020
  2. Study start23 Dec 2019
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04475094
Sponsor's protocol ID
19-080
Status last verified
Jul 2020
First submitted
15 Jul 2020
Last updated
17 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fihn SD, Gardin JM, Abrams J, Berra K, Blankenship JC, Dallas AP, Douglas PS, Foody JM, Gerber TC, Hinderliter AL, King SB 3rd, Kligfield PD, Krumholz HM, Kwong RY, Lim MJ, Linderbaum JA, Mack MJ, Munger MA, Prager RL, Sabik JF, Shaw LJ, Sikkema JD, Smith CR Jr, Smith SC Jr, Spertus JA, Williams SV, Anderson JL; American College of Cardiology Foundation/American Heart Association Task Force. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation. 2012 Dec 18;126(25):e354-471. doi: 10.1161/CIR.0b013e318277d6a0. Epub 2012 Nov 19. No abstract available.

    PubMed 23166211

  • Task Force Members; Montalescot G, Sechtem U, Achenbach S, Andreotti F, Arden C, Budaj A, Bugiardini R, Crea F, Cuisset T, Di Mario C, Ferreira JR, Gersh BJ, Gitt AK, Hulot JS, Marx N, Opie LH, Pfisterer M, Prescott E, Ruschitzka F, Sabate M, Senior R, Taggart DP, van der Wall EE, Vrints CJ; ESC Committee for Practice Guidelines; Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Knuuti J, Valgimigli M, Bueno H, Claeys MJ, Donner-Banzhoff N, Erol C, Frank H, Funck-Brentano C, Gaemperli O, Gonzalez-Juanatey JR, Hamilos M, Hasdai D, Husted S, James SK, Kervinen K, Kolh P, Kristensen SD, Lancellotti P, Maggioni AP, Piepoli MF, Pries AR, Romeo F, Ryden L, Simoons ML, Sirnes PA, Steg PG, Timmis A, Wijns W, Windecker S, Yildirir A, Zamorano JL. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013 Oct;34(38):2949-3003. doi: 10.1093/eurheartj/eht296. Epub 2013 Aug 30. No abstract available.

    PubMed 23996286

  • Shaw LJ, Blankstein R, Jacobs JE, Leipsic JA, Kwong RY, Taqueti VR, Beanlands RSB, Mieres JH, Flamm SD, Gerber TC, Spertus J, Di Carli MF; American Heart Association Cardiovascular Imaging and Intervention Subcommittee of the Council on Clinical Cardiology; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Disease in the Young; and Council on Quality of Care and Outcomes Research. Defining Quality in Cardiovascular Imaging: A Scientific Statement From the American Heart Association. Circ Cardiovasc Imaging. 2017 Dec;10(12):e000017. doi: 10.1161/HCI.0000000000000017.

    PubMed 29242239

  • Douglas PS, Cerqueira MD, Berman DS, Chinnaiyan K, Cohen MS, Lundbye JB, Patel RA, Sengupta PP, Soman P, Weissman NJ, Wong TC; ACC Cardiovascular Imaging Council. The Future of Cardiac Imaging: Report of a Think Tank Convened by the American College of Cardiology. JACC Cardiovasc Imaging. 2016 Oct;9(10):1211-1223. doi: 10.1016/j.jcmg.2016.02.027.

    PubMed 27712724

  • Fordyce CB, Douglas PS. Outcomes-Based CV Imaging Research Endpoints and Trial Design: From Pixels to Patient Satisfaction. JACC Cardiovasc Imaging. 2017 Mar;10(3):253-263. doi: 10.1016/j.jcmg.2017.01.010.

    PubMed 28279373

  • Bateman TM, Heller GV, McGhie AI, Friedman JD, Case JA, Bryngelson JR, Hertenstein GK, Moutray KL, Reid K, Cullom SJ. Diagnostic accuracy of rest/stress ECG-gated Rb-82 myocardial perfusion PET: comparison with ECG-gated Tc-99m sestamibi SPECT. J Nucl Cardiol. 2006 Jan-Feb;13(1):24-33. doi: 10.1016/j.nuclcard.2005.12.004.

    PubMed 16464714

  • Danad I, Raijmakers PG, Driessen RS, Leipsic J, Raju R, Naoum C, Knuuti J, Maki M, Underwood RS, Min JK, Elmore K, Stuijfzand WJ, van Royen N, Tulevski II, Somsen AG, Huisman MC, van Lingen AA, Heymans MW, van de Ven PM, van Kuijk C, Lammertsma AA, van Rossum AC, Knaapen P. Comparison of Coronary CT Angiography, SPECT, PET, and Hybrid Imaging for Diagnosis of Ischemic Heart Disease Determined by Fractional Flow Reserve. JAMA Cardiol. 2017 Oct 1;2(10):1100-1107. doi: 10.1001/jamacardio.2017.2471.

    PubMed 28813561

  • Murthy VL, Naya M, Foster CR, Hainer J, Gaber M, Di Carli G, Blankstein R, Dorbala S, Sitek A, Pencina MJ, Di Carli MF. Improved cardiac risk assessment with noninvasive measures of coronary flow reserve. Circulation. 2011 Nov 15;124(20):2215-24. doi: 10.1161/CIRCULATIONAHA.111.050427. Epub 2011 Oct 17.

    PubMed 22007073

  • Dorbala S, Di Carli MF. Cardiac PET perfusion: prognosis, risk stratification, and clinical management. Semin Nucl Med. 2014 Sep;44(5):344-57. doi: 10.1053/j.semnuclmed.2014.05.003.

    PubMed 25234079

  • Taqueti VR, Hachamovitch R, Murthy VL, Naya M, Foster CR, Hainer J, Dorbala S, Blankstein R, Di Carli MF. Global coronary flow reserve is associated with adverse cardiovascular events independently of luminal angiographic severity and modifies the effect of early revascularization. Circulation. 2015 Jan 6;131(1):19-27. doi: 10.1161/CIRCULATIONAHA.114.011939. Epub 2014 Nov 16.

    PubMed 25400060

  • Gould KL, Johnson NP, Bateman TM, Beanlands RS, Bengel FM, Bober R, Camici PG, Cerqueira MD, Chow BJW, Di Carli MF, Dorbala S, Gewirtz H, Gropler RJ, Kaufmann PA, Knaapen P, Knuuti J, Merhige ME, Rentrop KP, Ruddy TD, Schelbert HR, Schindler TH, Schwaiger M, Sdringola S, Vitarello J, Williams KA Sr, Gordon D, Dilsizian V, Narula J. Anatomic versus physiologic assessment of coronary artery disease. Role of coronary flow reserve, fractional flow reserve, and positron emission tomography imaging in revascularization decision-making. J Am Coll Cardiol. 2013 Oct 29;62(18):1639-1653. doi: 10.1016/j.jacc.2013.07.076. Epub 2013 Aug 28.

    PubMed 23954338

  • Taqueti VR, Shaw LJ, Cook NR, Murthy VL, Shah NR, Foster CR, Hainer J, Blankstein R, Dorbala S, Di Carli MF. Excess Cardiovascular Risk in Women Relative to Men Referred for Coronary Angiography Is Associated With Severely Impaired Coronary Flow Reserve, Not Obstructive Disease. Circulation. 2017 Feb 7;135(6):566-577. doi: 10.1161/CIRCULATIONAHA.116.023266. Epub 2016 Nov 14.

    PubMed 27881570

  • Shah NR, Charytan DM, Murthy VL, Skali Lami H, Veeranna V, Cheezum MK, Taqueti VR, Kato T, Foster CR, Hainer J, Gaber M, Klein J, Dorbala S, Blankstein R, Di Carli MF. Prognostic Value of Coronary Flow Reserve in Patients with Dialysis-Dependent ESRD. J Am Soc Nephrol. 2016 Jun;27(6):1823-9. doi: 10.1681/ASN.2015030301. Epub 2015 Oct 12.

    PubMed 26459635

  • Murthy VL, Naya M, Taqueti VR, Foster CR, Gaber M, Hainer J, Dorbala S, Blankstein R, Rimoldi O, Camici PG, Di Carli MF. Effects of sex on coronary microvascular dysfunction and cardiac outcomes. Circulation. 2014 Jun 17;129(24):2518-27. doi: 10.1161/CIRCULATIONAHA.113.008507. Epub 2014 Apr 30.

    PubMed 24787469

  • Murthy VL, Naya M, Foster CR, Gaber M, Hainer J, Klein J, Dorbala S, Blankstein R, Di Carli MF. Association between coronary vascular dysfunction and cardiac mortality in patients with and without diabetes mellitus. Circulation. 2012 Oct 9;126(15):1858-68. doi: 10.1161/CIRCULATIONAHA.112.120402. Epub 2012 Aug 23.

    PubMed 22919001

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Cardiovascular Imaging Technologies at 1 site in United States.

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 4 inclusion and 5 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 17 Jul 2020. 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 United States. 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?

Results are not available in the source record.

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

Contact Krishna Patel, MD (216-776-2196, kpatel@saint-lukes.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in SAQ-7 Angina Frequency (time frame: 3-8 weeks). The study lists 3 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 NCT04475094, which also lists 30 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 17 Jul 2020.

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