CONTRAST (Can cONTrast Injection Better Approximate FFR compAred to Pure reSTing Physiology?)

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Abbott Medical Devices; St. Jude Medical
• Treatments: Adenosine

Criteria

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.