A Trial Evaluating the Clinical Applicability, Correlation, and Modeling of Cardiac CT Using 64 Detector Row VCT - Full Text View

Sponsored by:	GE Healthcare
Information provided by:	GE Healthcare
ClinicalTrials.gov Identifier:	NCT00350506

Purpose

To compare computed tomography (CT) images (pictures) of the coronary arteries using the General Electric (GE) LightSpeed VCT scanner with x-ray coronary angiography in patients referred for an x-ray coronary angiography.

Condition	Intervention
Coronary Artery Disease	Device: 64 Channel VCT

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	An Open-Label, Non-Randomized, Multi-Center Trial Evaluating the Clinical Applicability, Correlation, and Modeling of Cardiac CT Using 64 Detector Row VCT

Further study details as provided by GE Healthcare:

Estimated Enrollment:	144
Study Start Date:	October 2005

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients scheduled for elective diagnostic catheterization OR
Elective diagnostic catheterization has been performed within the past 2 weeks but no less than 24 hours prior to the coronary CTA procedure with no intervention performed or change of the patient clinical status.
Age ≥18 years but ≤75 years.

Exclusion Criteria:

Prior coronary stent implantation
Prior coronary artery bypass grafting or other heart surgery
Prior pacemaker or internal defibrillator lead implantation
Prior artificial heart valve
Biochemical renal insufficiency (CrSerum > 1.6) or on dialysis
Resting HR > 100 at the time of enrollment
Contraindication to β-blockade or calcium channel blocker
- NYHA-IV
- High-grade atrioventricular (AV) block
- Systolic blood pressure <90 mm Hg
- Severe asthma or active bronchospasm and/or chronic obstructive pulmonary disease
Atrial fibrillation
Inability to provide informed consent
Evidence of ongoing or active clinical instability
- Acute chest pain (sudden onset)
- Acute myocardial infarction
- Cardiac shock
- Acute pulmonary edema

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350506

Locations

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

Sponsors and Collaborators

GE Healthcare

Investigators

Study Director:

Robert Centofanti, MS

GE Healthcare

More Information

Study ID Numbers:	VCT-001
Study First Received:	July 6, 2006
Last Updated:	August 15, 2007
ClinicalTrials.gov Identifier:	NCT00350506
Health Authority:	United States: Food and Drug Administration

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 14, 2009