Status:
TERMINATED
Safety and Effectiveness of Visipaque 320mg-I/ml for Use in Contrast-Enhanced CT Angiography of Arteries of the Heart
Lead Sponsor:
GE Healthcare
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
CT (computed tomography) angiography (CTA) is an examination similar to a CAT scan that uses x-rays and a contrast medium (also called dye) to visualize blood flow in arteries and veins throughout the...
Eligibility Criteria
Inclusion
- Subject is ≥18 years old.
- Subject must have been referred for an elective coronary angiography for one of several specified conditions.
Exclusion
- The subject has impaired renal function with a serum creatinine level ≥1.7 mg/dL (150 µmol/L). If the institution's practising guideline(s) regarding the serum creatinine limits for receiving radiologic contrast medium are lower than 1.7 mg/dL (150 µmol/L), the investigator should follow the practising guideline(s) of their institution.
- Subject has a known allergy to iodinated contrast agent
- Subject has atrial fibrillation/flutter or any irregular heart rhythm considered to interfere with temporal acquisition of cardiac CT images.
- The subject's resting heart rate is 66-100 bpm and β-blocker therapy is contraindicated.
- Use of nitroglycerin is contraindicated.
- Subject has had a prior CABG procedure.
- Subject has a metal cardiac stent in place or artificial heart valve(s).
- Subject has had a prior pacemaker or internal defibrillator lead implantation. Subject must agree to discontinue metformin day of and for 48 hours after the CTA procedure.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2006
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00335335
Start Date
May 1 2006
End Date
December 2 2006
Last Update
April 25 2019
Active Locations (1)
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1
Princeton, New Jersey, United States, 08540