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

Completed

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT02184117

Run by

The University of Texas Health Science Center, Houston

People needed

763

Starts

2014-07-01

Expected to finish

2015-05-01

Last updated by the study team

2016-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older.
• Undergoing FFR assessment for standard clinical indications.
• Ability to understand and willingness to sign a written informed consent.

You may not qualify if…

• 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.

Where it is running

• Stanford University, Palo Alto VA — Palo Alto, California, United States
• Integris Health — Oklahoma City, Oklahoma, United States
• Cardiovascular Center (OLV-Ziekenhuis) — Aalst, Belgium
• Hôpital Louis Pradel — Lyon, France
• University of Naples Federico II — Naples, Italy
• Catharina Hospital — Eindhoven, North Brabant, Netherlands
• Hospital Fernando Fonseca — Lisbon, Portugal
• Seoul National University College of Medicine — Seoul, South Korea
• Asan Medical Center — Seoul, South Korea
• Södersjukhuset — Stockholm, Sweden
• Golden Jubilee National Hospital — Clydebank, United Kingdom

Full record on ClinicalTrials.gov

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