Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 5:39 AM
Study NCT ID:
NCT04475094
Status:
UNKNOWN
Last Update Posted:
2020-07-17
First Post:
2020-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Coronary Artery Stenting on Quantitative Myocardial Blood Flow and Health Status
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000615479', 'term': 'Rubidium-82'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2020-07-15', 'studyFirstSubmitQcDate': '2020-07-15', 'lastUpdatePostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in SAQ-7 Angina Frequency', 'timeFrame': '3-8 weeks', 'description': '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.'}, {'measure': 'Change in MBFR', 'timeFrame': '3-8 weeks', 'description': '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).'}, {'measure': 'Extent of Epicaridal Stenoses', 'timeFrame': '3-8 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myocardial Blood Flow'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '23166211', 'type': 'BACKGROUND', 'citation': '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. 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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.'}, {'pmid': '25234079', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25400060', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23954338', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27881570', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26459635', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24787469', 'type': 'BACKGROUND', 'citation': '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. 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Epub 2007 Dec 19.'}, {'pmid': '7674504', 'type': 'BACKGROUND', 'citation': 'Gould KL, Ornish D, Scherwitz L, Brown S, Edens RP, Hess MJ, Mullani N, Bolomey L, Dobbs F, Armstrong WT, et al. Changes in myocardial perfusion abnormalities by positron emission tomography after long-term, intense risk factor modification. JAMA. 1995 Sep 20;274(11):894-901. doi: 10.1001/jama.1995.03530110056036.'}, {'pmid': '8149518', 'type': 'BACKGROUND', 'citation': 'Gould KL, Martucci JP, Goldberg DI, Hess MJ, Edens RP, Latifi R, Dudrick SJ. Short-term cholesterol lowering decreases size and severity of perfusion abnormalities by positron emission tomography after dipyridamole in patients with coronary artery disease. A potential noninvasive marker of healing coronary endothelium. Circulation. 1994 Apr;89(4):1530-8. doi: 10.1161/01.cir.89.4.1530.'}, {'pmid': '16133398', 'type': 'BACKGROUND', 'citation': 'Wielepp P, Baller D, Gleichmann U, Pulawski E, Horstkotte D, Burchert W. 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Development and validation of a short version of the Seattle angina questionnaire. Circ Cardiovasc Qual Outcomes. 2014 Sep;7(5):640-7. doi: 10.1161/CIRCOUTCOMES.114.000967. Epub 2014 Sep 2.'}, {'pmid': '23648778', 'type': 'BACKGROUND', 'citation': 'Rumsfeld JS, Alexander KP, Goff DC Jr, Graham MM, Ho PM, Masoudi FA, Moser DK, Roger VL, Slaughter MS, Smolderen KG, Spertus JA, Sullivan MD, Treat-Jacobson D, Zerwic JJ; American Heart Association Council on Quality of Care and Outcomes Research, Council on Cardiovascular and Stroke Nursing, Council on Epidemiology and Prevention, Council on Peripheral Vascular Disease, and Stroke Council. Cardiovascular health: the importance of measuring patient-reported health status: a scientific statement from the American Heart Association. Circulation. 2013 Jun 4;127(22):2233-49. doi: 10.1161/CIR.0b013e3182949a2e. Epub 2013 May 6. No abstract available.'}, {'pmid': '12093768', 'type': 'BACKGROUND', 'citation': 'Spertus JA, Jones P, McDonell M, Fan V, Fihn SD. Health status predicts long-term outcome in outpatients with coronary disease. Circulation. 2002 Jul 2;106(1):43-9. doi: 10.1161/01.cir.0000020688.24874.90.'}, {'pmid': '25991011', 'type': 'BACKGROUND', 'citation': 'McNamara RL, Spatz ES, Kelley TA, Stowell CJ, Beltrame J, Heidenreich P, Tresserras R, Jernberg T, Chua T, Morgan L, Panigrahi B, Rosas Ruiz A, Rumsfeld JS, Sadwin L, Schoeberl M, Shahian D, Weston C, Yeh R, Lewin J. Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM). J Am Heart Assoc. 2015 May 19;4(5):e001767. doi: 10.1161/JAHA.115.001767.'}, {'pmid': '4972212', 'type': 'BACKGROUND', 'citation': 'Rose GA, Blackburn H. Cardiovascular survey methods. Monogr Ser World Health Organ. 1968;56:1-188. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Hospital-Level-PRO-Based-PM-for-Patients-Undergoing-non-Emergent-PCI_Public-Comment-Summary-Report.pdf', 'label': 'Reference #30'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nWhile 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).\n\nTo 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The index clinically-indicated rest/regadenoson stress myocardial perfusion PET study shows at least one reversible perfusion defect; and\n2. The MBFR measurement meets quality control criteria for accuracy; and\n3. 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\n4. 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.\n\nExclusion Criteria:\n\n1. EF \\<40%\n2. Significant aortic stenosis/regurgitation\n3. Significant Mitral stenosis/regurgitation)\n4. Prior CABG\n5. 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)'}, 'identificationModule': {'nctId': 'NCT04475094', 'briefTitle': 'Impact of Coronary Artery Stenting on Quantitative Myocardial Blood Flow and Health Status', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cardiovascular Imaging Technologies'}, 'officialTitle': 'Impact of Coronary Artery Stenting on Quantitative Myocardial Blood Flow and Health Status', 'orgStudyIdInfo': {'id': '19-080'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COHORT', 'description': '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.', 'interventionNames': ['Drug: Rubidium-82', 'Behavioral: Seattle Angina Questionnaire-7', 'Behavioral: Rose Dyspnea Scale']}], 'interventions': [{'name': 'Rubidium-82', 'type': 'DRUG', 'otherNames': ['Myocardial Perfusion PET'], 'description': 'Consented subjects will undergo a rest/regadenoson stress myocardial perfusion PET study.', 'armGroupLabels': ['COHORT']}, {'name': 'Seattle Angina Questionnaire-7', 'type': 'BEHAVIORAL', 'description': 'Consented subjects will complete a SAQ-7.', 'armGroupLabels': ['COHORT']}, {'name': 'Rose Dyspnea Scale', 'type': 'BEHAVIORAL', 'description': 'Consented subjects will complete a RDS.', 'armGroupLabels': ['COHORT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Timothy M Bateman, MD', 'role': 'CONTACT', 'email': 'tbateman@cvit.com', 'phone': '816-531-2842', 'phoneExt': '102'}, {'name': 'Staci A Courter, MA', 'role': 'CONTACT', 'email': 'scourter@cvit.com', 'phone': '816-751-8542', 'phoneExt': '107'}, {'name': 'Krishna Patel, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'James Case, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Saint Luke's Hospital Imaging Center", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'centralContacts': [{'name': 'Krishna Patel, MD', 'role': 'CONTACT', 'email': 'kpatel@saint-lukes.org', 'phone': '216-776-2196'}, {'name': 'Staci Courter, MA', 'role': 'CONTACT', 'email': 'scourter@cvit.com', 'phone': '816-531-2842', 'phoneExt': '107'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiovascular Imaging Technologies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'Timothy M. Bateman, MD', 'investigatorAffiliation': 'Cardiovascular Imaging Technologies'}}}}