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

This study has been completed.
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00348608
First received: June 30, 2006
Last updated: June 28, 2007
Last verified: June 2007
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:

Drug Information available for: Iodixanol
U.S. FDA Resources

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: June 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: NCT00348608

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

No publications provided

ClinicalTrials.gov Identifier: NCT00348608     History of Changes
Other Study ID Numbers: DXV302
Study First Received: June 30, 2006
Last Updated: June 28, 2007
Health Authority: United States: Food and Drug Administration
China: Food and Drug Administration
India: Ministry of Health

Keywords provided by GE Healthcare:
Coronary
Angiography
X-ray
CAD

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013