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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02173275 |
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Date of registration:
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23/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Computed TomogRaphic Evaluation of Atherosclerotic DEtermiNants of Myocardial IsChEmia
CREDENCE |
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Scientific title:
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Computed TomogRaphic Evaluation of Atherosclerotic DEtermiNants of Myocardial IsChEmia (The CREDENCE Trial) |
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Date of first enrolment:
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May 2014 |
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Target sample size:
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618 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02173275 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Canada
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China
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Italy
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Japan
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Korea, Republic of
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Latvia
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Netherlands
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United States
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Contacts
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Name:
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Leslee J Shaw, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Weill Medical College of Cornell University |
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Key inclusion & exclusion criteria
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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 ß blockers or nitroglycerin or adenosine
12. BMI >40 kg/m2
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Myocardial Ischemia
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Primary Outcome(s)
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Diagnostic accuracy of vessel territory-specific ischemia of an integrated stenosis-APC-FFRCT measure by CT
[Time Frame: 48-60 months]
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Secondary Outcome(s)
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Post-PCI FFR prediction by FFRCT "virtual stenting"
[Time Frame: 48-60 months]
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Individual comparisons of APCs or FFRCT to MPI vessel-specific perfusion deficits or reduced MBF.
[Time Frame: 48-60 months]
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Secondary ID(s)
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1309014313
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R01HL118019
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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