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Study in Subjects Suspected of Having CAD Undergoing VISIPAQUE-enhanced CCTA as Part of Their Routine Medical Care

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00783302
First received: October 30, 2008
Last updated: September 15, 2011
Last verified: September 2011
History of Changes
  Purpose

To assess prognostic value of CCTA examination in subjects who undergo CCTA as part of their medical care when compared to a standard of truth, i.e. subject outcomes during each follow-up period.


Condition
Coronary Artery Disease (CAD)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Multi-Center Registry Study for Clinical Outcome in Subjects Undergoing Coronary Computed Tomography Angiography (CCTA) Examination (VISIPAQUE Registry Study)

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:
  • Assess sensitivity, specificity, positive predictive value and NPV of CCTA examination who clinically undergo CCTA as part of the medical care when compared to a standard of truth or binary subject outcomes during each follow-up period. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine predictive ability of various findings of VISIPAQUE-enhanced CCTA on subject outcome events. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment: 877
Study Start Date: September 2008
Study Completion Date: April 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient suspected of having coronary artery disease or CAD.

Criteria

Inclusion Criteria:

  • The subject is over 18 years old, exhibits chest pain syndrome and is scheduled to undergo a VISIPAQUE-enhanced CCTA examination for one of the following reasons:- Intermediate pre-test probability of CAD.
  • An uninterruptible/equivocal stress test (exercise, perfusion, or stress echo).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00783302

Locations
United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
Investigators
Principal Investigator: Rubin Sheng, M.D. GE Healthcare
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00783302     History of Changes
Other Study ID Numbers: GE-012-096
Study First Received: October 30, 2008
Last Updated: September 15, 2011
Health Authority: United States: Institutional Review Board
Canada: Health Canada

Keywords provided by GE Healthcare:
CAD
Visipaque
CCTA

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 June 18, 2013