Computed TomogRaphic Evaluation of Atherosclerotic DEtermiNants of Myocardial IsChEmia

NCT ID: NCT02173275

Last Updated: 2019-11-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 618 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2018-01-18

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.

Conditions

Myocardial Ischemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

derivation cohort

n = 309

No interventions assigned to this group

validation cohort

n = 309

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslee J Shaw, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Heart Center Research, LLC

Huntsville, Alabama, United States

Mobile Cardiology Associates

Mobile, Alabama, United States

Kaiser Permanente Hospital

San Jose, California, United States

Oconee Heart and Vascular Center at St Mary's Hospital

Athens, Georgia, United States

St. Luke's Lipid and Diabetes Research Center

Kansas City, Missouri, United States

Renown Heart and Vascular

Reno, Nevada, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Houston Methodist Hospital

Houston, Texas, United States

Cardiac Center of Texas

McKinney, Texas, United States

Multicare HS Institute for Research & Innovation

Tacoma, Washington, 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

Countries

United States; Canada; China; Italy; Japan; Latvia; Netherlands; South Korea

References

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.

Reference Type: BACKGROUND

PMID: 27716131 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35441530 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35183478 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32822476 (View on PubMed)

Other Identifiers

R01HL118019

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1309014313

Identifier Type: -

Identifier Source: org_study_id