Safety and Effectiveness of Visipaque 320mg-I/ml for Use in Contrast-Enhanced CT Angiography of Arteries of the Heart

Stopped early · Phase 3

Conditions studied: Coronary Artery Disease

In brief

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 body. VISIPAQUE™ will be given through a vein in the arm before having the CTA scan of the heart arteries. The pictures it produces of the heart and its blood vessels will be reviewed and compared to those obtained during the catheter-based coronary angiography to see if the CTA shows the same blockages.

Key facts

Study ID

NCT00335335

Run by

GE Healthcare

People needed

89

Starts

2006-05-01

Expected to finish

2006-12-02

Last updated by the study team

2019-04-25

Who can join

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

You may qualify if…

• Subject is ≥18 years old.
• Subject must have been referred for an elective coronary angiography for one of several specified conditions.

You may not qualify if…

• 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.

Where it is running

• Study site — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

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