Status:
COMPLETED
CONTRAST (Can cONTrast Injection Better Approximate FFR compAred to Pure reSTing Physiology?)
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
Abbott Medical Devices
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief 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 st...
Detailed Description
We are conducting a diagnostic accuracy study. The reference standard is adenosine-derived FFR. The diagnostic tests undergoing evaluation are resting conditions and hyperemia induced by intracoronary...
Eligibility Criteria
Inclusion
- Age 18 years or older.
- Undergoing FFR assessment for standard clinical indications.
- Ability to understand and willingness to sign a written informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
763 Patients enrolled
Trial Details
Trial ID
NCT02184117
Start Date
July 1 2014
End Date
May 1 2015
Last Update
May 16 2016
Active Locations (11)
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1
Stanford University, Palo Alto VA
Palo Alto, California, United States, 94304
2
Integris Health
Oklahoma City, Oklahoma, United States, 73112
3
Cardiovascular Center (OLV-Ziekenhuis)
Aalst, Belgium
4
Hôpital Louis Pradel
Lyon, France