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

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Drug: iodixanol	Phase III

MedlinePlus related topics:

Coronary Artery Disease X-Rays

ChemIDplus related topics:

Iodixanol X-Rays

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by GE Healthcare:

Primary Outcome Measures:

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

Estimated Enrollment:	540
Study Start Date:	May 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335335

Locations


United States, New Jersey

	Princeton, New Jersey, United States, 08540

Sponsors and Collaborators

GE Healthcare

Investigators


Study Director:	Veronica Reichl	GE Healthcare

More Information

Study ID Numbers:	DXV301
First Received:	June 7, 2006
Last Updated:	June 28, 2007
ClinicalTrials.gov Identifier:	NCT00335335
Health Authority:	United States: Food and Drug Administration

Keywords provided by GE Healthcare:

Coronary

Angiography

X-ray

CAD

Study placed in the following topic categories:

Arterial Occlusive Diseases

Coronary Disease

Heart Diseases

Myocardial Ischemia

Vascular Diseases

Arteriosclerosis

Ischemia

Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 14, 2008

Sponsored by:	GE Healthcare
Information provided by:	GE Healthcare
ClinicalTrials.gov Identifier:	NCT00335335