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

NCT00335335 | Terminated Phase 3

• 1 other identifier: DXV301
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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

Keywords

Coronary; Angiography; X-ray; CAD

Outcome Measures

Primary Outcomes (1)

• To evaluate diagnostic performance and safety of Visipaque-enhanced CTA images for determination of presence or absence of coronary artery obstruction

  48 hours

Study Arms (1)

Visipaque Injection

EXPERIMENTAL

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

Interventions

iodixanol DRUG

Also known as: Visipaque

Visipaque Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Unknown Facility

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

iodixanol

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Veronica Reichl

  GE Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2006
• First Posted: June 9, 2006
• Study Start: May 1, 2006
• Primary Completion: December 2, 2006
• Study Completion: December 2, 2006
• Last Updated: April 25, 2019

Record last verified: 2019-04

Locations

US (1)