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Sponsored by: |
GE Healthcare |
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Information provided by: | GE Healthcare |
ClinicalTrials.gov Identifier: | NCT00335335 |
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 |
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Coronary Artery Disease |
Drug: iodixanol |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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.
Study ID Numbers: | DXV301 |
Study First Received: | June 7, 2006 |
Last Updated: | June 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00335335 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Coronary Angiography X-ray CAD |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |