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

NCT ID: NCT00348608

Last Updated: 2019-04-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2006-12-02

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 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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Visipaque Injection

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.

Group Type: EXPERIMENTAL

iodixanol

Intervention Type: DRUG

Interventions

iodixanol

Intervention Type: DRUG

Other Intervention Names

Visipaque

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Veronica Reichl

Role: STUDY_DIRECTOR

GE Healthcare

Locations

Princeton, New Jersey, United States

Countries

United States

Other Identifiers

DXV302

Identifier Type: -

Identifier Source: org_study_id