The Evaluation of the Roles of New Cardiac Imaging in Patients With Chest Pain (NCT03800862) | Clinical Trial Compass
TerminatedNot Applicable
The Evaluation of the Roles of New Cardiac Imaging in Patients With Chest Pain
Stopped: PI departure from institution + Enrollment Challenges
United States14 participantsStarted 2019-03-27
Plain-language summary
This is a prospective, observational study designed to evaluate the role of dynamic computed tomographic perfusion (CTP) and Computed Tomography-Derived Fractional Flow Reserve (CT-FFR) in patients presenting with chest discomfort.Patients with lesions greater than 50% and who meet all other inclusion/exclusion criteria will qualify to be a subject in the CTP study /CT-FFR 49. Those who agree to participate will be scheduled to have the CT-FFR and CTP performed within sixty days of the initial Coronary CTA procedure. A CTA will be performed at rest for FFR. The patient will then take approximately a 30 min break. Regadenoson will then be administered and the dynamic CT procedure will be done for perfusion. If patients are deemed to be appropriate for invasive angiography by the referring physician, coronary lesions between 40% and 80% will get a fractional flow measurement performed if indicated on a clinical basis. Stenosis in vessels less than 1.5 mm will be excluded from the study. The CT-FFR and CTP will be performed in these patients within 60 days of index coronary angiography.
Who can participate
Age range45 Years – 85 Years
SexALL
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Inclusion criteria
✓. Age 45 - 85 years.
✓. Clinically indicated coronary CTA with one or more lesions greater than 50% in the epicardial vessels.
✓. Referring physician agreement to approach the patient for consent.
✓. Informed consent from the patient or authorized representative.
✓. Scheduled CTA for CT-FFR and CTP within 60 days of the clinically indicated CCTA and prior to any indicated coronary angiography.
Exclusion criteria
✕. CCTA complication. After an observation period of at least 20 minutes after the index CCTA, any evidence of MACE, allergy, or any other untoward clinical event that reduces CTP safety or suitability (as defined by attending physician) will exclude a patient from eligibility.
✕. Medical record of acute ischemia as evidenced on ECG or positive cardiac biomarkers in the interim between index CCTA and CTA for CT-FFR and CTP. Electrocardiographic evidence of acute ischemia includes acute STEMI (ST elevation equal to or greater than 1mm in two or more leads), ST segment depression and/or T wave inversion (not known to be old and thought to be evidence of ongoing ischemia). Positive cardiac biomarkers include elevated troponin, myoglobin).
What they're measuring
1
Performance of dynamic CTP and CT-FFR for each vessel assessed in patients presenting with chest pain.
Timeframe: Day of imaging (processing of CT-FFR images and reading of CTP images expected to be performed within 48 hours of imaging)