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

This study has been completed.
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00350506
First received: July 6, 2006
Last updated: August 15, 2007
Last verified: August 2007
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

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

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 23, 2013