CREDENCE: Computed TomogRaphic Evaluation of Atherosclerotic DEtermiNants of Myocardial IsChEmia
Study Details
Study Description
Brief Summary
The study seeks to determine the accuracy of using anatomic and physiologic information measurable by computed tomography features of stenosis, plaque, fractional flow reserve-CT and to compare this measure to stress testing for the detection of myocardial ischemia against the gold standard of cardiac catheterization with fractional flow reserve. The hypothesis of this proposal is that integrating anatomic plaque features with physiologic fractional flow reserve-CT will optimize identification of coronary lesions that are ischemia-causing by computed tomography .
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The CREDENCE trial will be a prospective multicenter cross-sectional study of 618 individuals (n=309 [derivation cohort]; n=309 [validation cohort]) who will undergo stress test, computed tomography, cardiac catheterization and fractional flow reserve. For the purposes of the study, either stress test or computed tomography will have been performed for clinical purposes, with the other test being performed as part of trial procedure. Study analyses will focus on the diagnostic performance of the information derived by stress test versus computed tomography against an invasive gold standard of cardiac catheterization and fractional flow reserve for an endpoint of vessel territory-specific ischemia. In keeping with prior studies, vessel territories will be comprised of the left anterior descending artery (and diagonal branches), the left circumflex artery (and obtuse marginal branches) and the right coronary artery (and posterolateral branch and posterior descending artery).
To date, the relative performance of traditional stress imaging testing compared to the entirety of information proffered by CT has not been assessed compared to an unbiased gold standard. The study proposed herein will directly address this unmet need.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| derivation cohort n = 309 |
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| validation cohort n = 309 |
Outcome Measures
Primary Outcome Measures
- Diagnostic accuracy of vessel territory-specific ischemia of an integrated stenosis-APC-FFRCT measure by CT [48-60 months]
The primary endpoint is the diagnostic accuracy of an integrated stenosis-APC-FFRCT metric by CT, as compared to perfusion or perfusion-MBF stress imaging testing for vessel territory-specific ischemia as determined by FFR (gold standard).
Secondary Outcome Measures
- Individual comparisons of APCs or FFRCT to MPI vessel-specific perfusion deficits or reduced MBF. [48-60 months]
To compare the accuracy of the individual components of APCs or FFRCT to MPI vessel-specific perfusion deficits or reduced MBF against ischemia by FFR.
- Post-PCI FFR prediction by FFRCT "virtual stenting" [48-60 months]
To determine the accuracy of FFRCT "virtual stenting" to post-PCI FFR value of >0.80 and determine the correlation between the FFRCT "virtual stenting" to post-PCI FFR.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age >18 years
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Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography
Exclusion Criteria:
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Known CAD (myocardial infarction [MI], percutaneous coronary interventions [PCIs], coronary artery bypass graft [CABG],)
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Hemodynamic instability
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Inability to provide written informed consent
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Concomitant participation in another clinical trial in which subject is subject to investigational drug or device
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Pregnant state
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Absolute contraindication to iodinated contrast due to prior near-fatal anaphylactoid reaction (laryngospasm, bronchospasm, cardiorespiratory collapse, or equivalent)
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Serum creatinine ≥1.7 mg/dl or Glomerular Filtration Rate <30 ml/min
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Baseline irregular heart rhythm (e.g., atrial fibrillation, etc.)
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Heart rate ≥100 beats per minute
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Systolic blood pressure ≤90 mm Hg
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Contraindications to β blockers or nitroglycerin or adenosine
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BMI >40 kg/m2
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Heart Center Research, LLC | Huntsville | Alabama | United States | 35801 |
| 2 | Mobile Cardiology Associates | Mobile | Alabama | United States | 36608 |
| 3 | Kaiser Permanente Hospital | San Jose | California | United States | 95119 |
| 4 | Oconee Heart and Vascular Center at St Mary's Hospital | Athens | Georgia | United States | 30606 |
| 5 | St. Luke's Lipid and Diabetes Research Center | Kansas City | Missouri | United States | 64111 |
| 6 | Renown Heart and Vascular | Reno | Nevada | United States | 89502 |
| 7 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 8 | Houston Methodist Hospital | Houston | Texas | United States | 77030 |
| 9 | Cardiac Center of Texas | McKinney | Texas | United States | 75069 |
| 10 | Multicare HS Institute for Research & Innovation | Tacoma | Washington | United States | 98372 |
| 11 | Providence Health Care- St. Paul's Hospital; University of British Columbia | Vancouver | British Columbia | Canada | |
| 12 | State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | China | ||
| 13 | Centro Cardiologico Monzino, IRCCS and University of Milan | Milan | Italy | ||
| 14 | Fondazione Toscana Gabriele Monasterio | Pisa | Italy | ||
| 15 | St. Luke's Hospital | Tokyo | Japan | ||
| 16 | Severance Cardiovascular Hospital | Seoul | Korea, Republic of | ||
| 17 | Paul Stradins University Hospital | Riga | Latvia | ||
| 18 | VU University Medical Center | Amsterdam | Netherlands |
Sponsors and Collaborators
- Weill Medical College of Cornell University
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Leslee J Shaw, PhD, Weill Medical College of Cornell University
Study Documents (Full-Text)
None provided.More Information
Publications
- 1309014313
- R01HL118019