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

This study is currently recruiting participants.

Verified by GE Healthcare, October 2008

Sponsored by:	GE Healthcare
Information provided by:	GE Healthcare
ClinicalTrials.gov Identifier:	NCT00783302

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)

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Iodixanol

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1000
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 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

Contacts

Contact: Veronica Reichl

609-514-6849

veronica.reichl@ge.com

Locations

United States, New Jersey
GE Healthcare	Recruiting
Princeton, New Jersey, United States, 08540

Sponsors and Collaborators

GE Healthcare

Investigators

Principal Investigator:

Rubin Sheng, M.D.

GE Healthcare

More Information

Responsible Party:	GE Healthcare ( Rubin Sheng, M.D. )
Study ID Numbers:	GE-012-096
Study First Received:	October 30, 2008
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00783302
Health Authority:	United States: Institutional Review Board; Canada: Health Canada

Keywords provided by GE Healthcare:

CAD
Visipaque
CCTA

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 January 16, 2009