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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL118019 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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 .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| derivation cohort | n = 309 | ||
| validation cohort | n = 309 |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of vessel territory-specific ischemia of an integrated stenosis-APC-FFRCT measure by CT | 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). | 48-60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Individual comparisons of APCs or FFRCT to MPI vessel-specific perfusion deficits or reduced MBF. | 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. | 48-60 months |
| Post-PCI FFR prediction by FFRCT "virtual stenting" |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive consenting adult patients who meet all of the inclusion criteria and none of the exclusion criteria will be asked to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Leslee J Shaw, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Research, LLC | Huntsville | Alabama | 35801 | United States | ||
| Mobile Cardiology Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27716131 | Background | Rizvi A, Hartaigh BO, Knaapen P, Leipsic J, Shaw LJ, Andreini D, Pontone G, Raman S, Khan MA, Ridner M, Nabi F, Gimelli A, Jang J, Cole J, Nakazato R, Zarins C, Han D, Lee JH, Szymonifika J, Gomez MJ, Truong QA, Chang HJ, Lin FY, Min JK. Rationale and Design of the CREDENCE Trial: computed TomogRaphic evaluation of atherosclerotic DEtermiNants of myocardial IsChEmia. BMC Cardiovasc Disord. 2016 Oct 6;16(1):190. doi: 10.1186/s12872-016-0360-x. | |
| 35441530 |
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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. |
| 48-60 months |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Kaiser Permanente Hospital | San Jose | California | 95119 | United States |
| Oconee Heart and Vascular Center at St Mary's Hospital | Athens | Georgia | 30606 | United States |
| St. Luke's Lipid and Diabetes Research Center | Kansas City | Missouri | 64111 | United States |
| Renown Heart and Vascular | Reno | Nevada | 89502 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| Cardiac Center of Texas | McKinney | Texas | 75069 | United States |
| Multicare HS Institute for Research & Innovation | Tacoma | Washington | 98372 | United States |
| Providence Health Care- St. Paul's Hospital; University of British Columbia | Vancouver | British Columbia | Canada |
| 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 |
| Centro Cardiologico Monzino, IRCCS and University of Milan | Milan | Italy |
| Fondazione Toscana Gabriele Monasterio | Pisa | Italy |
| St. Luke's Hospital | Tokyo | Japan |
| Paul Stradins University Hospital | Riga | Latvia |
| VU University Medical Center | Amsterdam | Netherlands |
| Severance Cardiovascular Hospital | Seoul | South Korea |
| Lipkin I, Telluri A, Kim Y, Sidahmed A, Krepp JM, Choi BG, Jonas R, Marques H, Chang HJ, Choi JH, Doh JH, Her AY, Koo BK, Nam CW, Park HB, Shin SH, Cole J, Gimelli A, Khan MA, Lu B, Gao Y, Nabi F, Nakazato R, Schoepf UJ, Driessen RS, Bom MJ, Jang JJ, Ridner M, Rowan C, Avelar E, Genereux P, Knaapen P, de Waard GA, Pontone G, Andreini D, Al-Mallah MH, Crabtree TR, Earls JP, Choi AD, Min JK. Coronary CTA With AI-QCT Interpretation: Comparison With Myocardial Perfusion Imaging for Detection of Obstructive Stenosis Using Invasive Angiography as Reference Standard. AJR Am J Roentgenol. 2022 Sep;219(3):407-419. doi: 10.2214/AJR.21.27289. Epub 2022 Apr 20. |
| 35183478 | Derived | Griffin WF, Choi AD, Riess JS, Marques H, Chang HJ, Choi JH, Doh JH, Her AY, Koo BK, Nam CW, Park HB, Shin SH, Cole J, Gimelli A, Khan MA, Lu B, Gao Y, Nabi F, Nakazato R, Schoepf UJ, Driessen RS, Bom MJ, Thompson R, Jang JJ, Ridner M, Rowan C, Avelar E, Genereux P, Knaapen P, de Waard GA, Pontone G, Andreini D, Earls JP. AI Evaluation of Stenosis on Coronary CTA, Comparison With Quantitative Coronary Angiography and Fractional Flow Reserve: A CREDENCE Trial Substudy. JACC Cardiovasc Imaging. 2023 Feb;16(2):193-205. doi: 10.1016/j.jcmg.2021.10.020. Epub 2022 Feb 16. |
| 32822476 | Derived | Stuijfzand WJ, van Rosendael AR, Lin FY, Chang HJ, van den Hoogen IJ, Gianni U, Choi JH, Doh JH, Her AY, Koo BK, Nam CW, Park HB, Shin SH, Cole J, Gimelli A, Khan MA, Lu B, Gao Y, Nabi F, Nakazato R, Schoepf UJ, Driessen RS, Bom MJ, Thompson R, Jang JJ, Ridner M, Rowan C, Avelar E, Genereux P, Knaapen P, de Waard GA, Pontone G, Andreini D, Al-Mallah MH, Lu Y, Berman DS, Narula J, Min JK, Bax JJ, Shaw LJ; CREDENCE Investigators. Stress Myocardial Perfusion Imaging vs Coronary Computed Tomographic Angiography for Diagnosis of Invasive Vessel-Specific Coronary Physiology: Predictive Modeling Results From the Computed Tomographic Evaluation of Atherosclerotic Determinants of Myocardial Ischemia (CREDENCE) Trial. JAMA Cardiol. 2020 Dec 1;5(12):1338-1348. doi: 10.1001/jamacardio.2020.3409. |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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