Computed TomogRaphic Evaluation of Atherosclerotic DEtermiNants of Myocardial IsChEmia (CREDENCE)

November 11, 2019 updated by: Weill Medical College of Cornell University

Computed TomogRaphic Evaluation of Atherosclerotic DEtermiNants of Myocardial IsChEmia (The CREDENCE Trial)

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 .

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

618

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Providence Health Care- St. Paul's Hospital; University of British Columbia
  • China
      • Beijing, China
        • State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
  • Italy
      • Milan, Italy
        • Centro Cardiologico Monzino, IRCCS and University of Milan
      • Pisa, Italy
        • Fondazione Toscana Gabriele Monasterio
  • Japan
      • Tokyo, Japan
        • St. Luke's Hospital
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Severance Cardiovascular Hospital
  • Latvia
      • Riga, Latvia
        • Paul Stradins University Hospital
  • Netherlands
      • Amsterdam, Netherlands
        • VU University Medical Center
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research, LLC
      • Mobile, Alabama, United States, 36608
        • Mobile Cardiology Associates
    • California
      • San Jose, California, United States, 95119
        • Kaiser Permanente Hospital
    • Georgia
      • Athens, Georgia, United States, 30606
        • Oconee Heart and Vascular Center at St Mary's Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Lipid and Diabetes Research Center
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Heart and Vascular
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • McKinney, Texas, United States, 75069
        • Cardiac Center of Texas
    • Washington
      • Tacoma, Washington, United States, 98372
        • Multicare HS Institute for Research & Innovation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
derivation cohort
n = 309
validation cohort
n = 309

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of vessel territory-specific ischemia of an integrated stenosis-APC-FFRCT measure by CT
Time Frame: 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).
48-60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual comparisons of APCs or FFRCT to MPI vessel-specific perfusion deficits or reduced MBF.
Time Frame: 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.
48-60 months
Post-PCI FFR prediction by FFRCT "virtual stenting"
Time Frame: 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.
48-60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

May 9, 2017

Study Completion (Actual)

January 18, 2018

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimate)

June 24, 2014

Study Record Updates

Last Update Posted (Actual)

November 13, 2019

Last Update Submitted That Met QC Criteria

November 11, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1309014313
  • R01HL118019 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Ischemia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe