Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

The University of Texas Health Science Center, Houston

Collaborator: Abbott Medical Devices

Stanford Investigator(s):

Intervention(s):

  • Drug: Adenosine
  • Drug: Contrast Media
  • Drug: Resting conditions

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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting