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CONTRAST (Can cONTrast Injection Better Approximate FFR compAred to Pure reSTing Physiology?)
Not Recruiting
Trial ID: NCT02184117
Purpose
The purpose of this study is to determine the diagnostic performances of iodine contrast
medium and resting conditions to predict fractional flow reserve (FFR). Reference FFR will be
measured using standard adenosine. We hypothesize that contrast FFR will offer superior
diagnostic agreement compared to resting conditions.
Official Title
CONTRAST (Can cONTrast Injection Better Approximate FFR compAred to Pure reSTing Physiology?)
Stanford Investigator(s)
William Fearon, MD
Professor of Medicine (Cardiovascular Medicine)
Eligibility
Inclusion Criteria:
- Age 18 years or older.
- Undergoing FFR assessment for standard clinical indications.
- Ability to understand and willingness to sign a written informed consent.
Exclusion Criteria:
- Prior coronary artery bypass grafting (CABG).
- Extremely tortuous or calcified coronary arteries precluding intracoronary physiologic
measurements. Operators may exclude subtotal or similar high-grade lesions, which in
their judgment may be threatened by pressure wire placement.
- Known severe left ventricular hypertrophy (septal wall thickness at echocardiography
of >13 mm).
- Inability to receive adenosine (for example, severe reactive airway disease, marked
hypotension, or advanced atrioventricular block without pacemaker).
- Recent (within 3 weeks prior to cardiac catheterization) ST-segment elevation
myocardial infarction (STEMI) in any arterial distribution (not specifically target
lesion).
- Culprit lesions (based on clinical judgment of the operator) for either STEMI or
non-STEMI cannot be included.
- Severe cardiomyopathy (ejection fraction <30%).
- Renal insufficiency such that an additional 12 to 20 mL of contrast would, in the
opinion of the operator, pose unwarranted risk to the patient.
Intervention(s):
drug: Adenosine
drug: Contrast Media
drug: Resting conditions
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305