Clinical trial NCT02173275: Computed TomogRaphic Evaluation of Atherosclerotic DEtermiNants of Myocardial IsChEmia
Official title: Computed TomogRaphic Evaluation of Atherosclerotic DEtermiNants of Myocardial IsChEmia (The CREDENCE Trial)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Ischemia
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-06-24
Enrollment: 618
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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 .

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.

Eligibility criteria: Inclusion Criteria:

1. Age \>18 years
2. Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography

Exclusion Criteria:

1. Known CAD (myocardial infarction \[MI\], percutaneous coronary interventions \[PCIs\], coronary artery bypass graft \[CABG\],)
2. Hemodynamic instability
3. Inability to provide written informed consent
4. Concomitant participation in another clinical trial in which subject is subject to investigational drug or device
5. Pregnant state
6. Absolute contraindication to iodinated contrast due to prior near-fatal anaphylactoid reaction (laryngospasm, bronchospasm, cardiorespiratory collapse, or equivalent)
7. Serum creatinine ≥1.7 mg/dl or Glomerular Filtration Rate \<30 ml/min
8. Baseline irregular heart rhythm (e.g., atrial fibrillation, etc.)
9. Heart rate ≥100 beats per minute
10. Systolic blood pressure ≤90 mm Hg
11. Contraindications to β blockers or nitroglycerin or adenosine
12. BMI \>40 kg/m2

Primary outcomes:
measure: Diagnostic accuracy of vessel territory-specific ischemia of an integrated stenosis-APC-FFRCT measure by CT
timeFrame: 48-60 months
Secondary outcomes:
measure: Individual comparisons of APCs or FFRCT to MPI vessel-specific perfusion deficits or reduced MBF.
timeFrame: 48-60 months
measure: Post-PCI FFR prediction by FFRCT "virtual stenting"
timeFrame: 48-60 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Mobile
country: United States
facility: Mobile Cardiology Associates
state: Alabama
city: San Jose
country: United States
facility: Kaiser Permanente Hospital
state: California
city: Athens
country: United States
facility: Oconee Heart and Vascular Center at St Mary's Hospital
state: Georgia
city: Kansas City
country: United States
facility: St. Luke's Lipid and Diabetes Research Center
state: Missouri
city: Reno
country: United States
facility: Renown Heart and Vascular
state: Nevada
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: McKinney
country: United States
facility: Cardiac Center of Texas
state: Texas
city: Tacoma
country: United States
facility: Multicare HS Institute for Research & Innovation
state: Washington
city: Vancouver
country: Canada
facility: Providence Health Care- St. Paul's Hospital; University of British Columbia
state: British Columbia
city: Beijing
country: China
facility: State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
city: Milan
country: Italy
facility: Centro Cardiologico Monzino, IRCCS and University of Milan
city: Pisa
country: Italy
facility: Fondazione Toscana Gabriele Monasterio
city: Tokyo
country: Japan
facility: St. Luke's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular Hospital
city: Riga
country: Latvia
facility: Paul Stradins University Hospital
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
Study officials:
affiliation: Weill Medical College of Cornell University
name: Leslee J Shaw, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.