Computed TomogRaphic Evaluation of Atherosclerotic DEtermiNants of Myocardial IsChEmia

Completed

• Conditions: Myocardial Ischemia

• Registration Number: NCT02173275
• Lead Sponsor: Weill Medical College of Cornell University

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-06-23
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-24
• Primary Completion: 2017-05-09
• Study Completion: 2018-01-18
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-11
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 618

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (18)

Heart Center Research, LLC; 🇺🇸 Huntsville, 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

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Cardiac Center of Texas; 🇺🇸 McKinney, Texas, United States

Multicare HS Institute for Research & Innovation; 🇺🇸 Tacoma, Washington, United States

Centro Cardiologico Monzino, IRCCS and University of Milan; 🇮🇹 Milan, Italy

Fondazione Toscana Gabriele Monasterio; 🇮🇹 Pisa, Italy

Severance Cardiovascular Hospital; 🇰🇷 Seoul, Korea, Republic of

St. Luke's Hospital; 🇯🇵 Tokyo, Japan

VU University Medical Center; 🇳🇱 Amsterdam, Netherlands

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States

Renown Heart and Vascular; 🇺🇸 Reno, Nevada, United States

Mobile Cardiology Associates; 🇺🇸 Mobile, Alabama, United States

Paul Stradins University Hospital; 🇱🇻 Riga, Latvia

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