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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.



Information from the National Library of Medicine

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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
Show Show 18 study locations
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02173275    
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