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

Study Overview
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Brief Summary
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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.

Official Title
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Phase 3, Open-label, Multicenter Studies to Determine Efficacy and Safety of VISIPAQUETM (Iodixanol) Injection for Use in Intravenous Contrast-Enhanced CT Angiography of Coronary Arteries

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: iodixanol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is ≥18 years old. Subject must have been referred for an elective coronary angiography for one of several specified conditions. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Visipaque Injection<br>All participants will receive intravenous (IV) administration of 80 mL Visipaque (iodixanol) 320 mg-I/mL at a rate of 4-5 mL per second via power injector followed by a saline injection of 40-50 mL 0.9% sodium chloride solution at a rate of 4-5 mL per second. | Drug: iodixanol<br> <br> * Other names: Visipaque;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate diagnostic performance and safety of Visipaque-enhanced CTA images for determination of presence or absence of coronary artery obstruction |  | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary, Angiography, X-ray, CAD