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

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ClinicalTrials.gov Identifier: NCT02173275
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
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 .

Condition or disease
Myocardial Ischemia

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.


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Study Type : Observational
Actual Enrollment : 618 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Computed TomogRaphic Evaluation of Atherosclerotic DEtermiNants of Myocardial IsChEmia (The CREDENCE Trial)
Actual Study Start Date : May 2014
Actual Primary Completion Date : May 9, 2017
Actual Study Completion Date : January 18, 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02173275


Locations
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United States, Alabama
Heart Center Research, LLC
Huntsville, Alabama, United States, 35801
Mobile Cardiology Associates
Mobile, Alabama, United States, 36608
United States, California
Kaiser Permanente Hospital
San Jose, California, United States, 95119
United States, Georgia
Oconee Heart and Vascular Center at St Mary's Hospital
Athens, Georgia, United States, 30606
United States, Missouri
St. Luke's Lipid and Diabetes Research Center
Kansas City, Missouri, United States, 64111
United States, Nevada
Renown Heart and Vascular
Reno, Nevada, United States, 89502
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Houston Methodist Hospital
Houston, Texas, United States, 77030
Cardiac Center of Texas
McKinney, Texas, United States, 75069
United States, Washington
Multicare HS Institute for Research & Innovation
Tacoma, Washington, United States, 98372
Canada, British Columbia
Providence Health Care- St. Paul's Hospital; University of British Columbia
Vancouver, British Columbia, Canada
China
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
Italy
Centro Cardiologico Monzino, IRCCS and University of Milan
Milan, Italy
Fondazione Toscana Gabriele Monasterio
Pisa, Italy
Japan
St. Luke's Hospital
Tokyo, Japan
Korea, Republic of
Severance Cardiovascular Hospital
Seoul, Korea, Republic of
Latvia
Paul Stradins University Hospital
Riga, Latvia
Netherlands
VU University Medical Center
Amsterdam, Netherlands
Sponsors and Collaborators
Weill Medical College of Cornell University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Leslee J Shaw, PhD Weill Medical College of Cornell University

Publications:
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02173275     History of Changes
Other Study ID Numbers: 1309014313
R01HL118019 ( U.S. NIH Grant/Contract )
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Myocardial Ischemia
Coronary Artery Disease
Ischemia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases