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

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ClinicalTrials.gov Identifier: NCT00350506
Recruitment Status : Completed
First Posted : July 10, 2006
Last Update Posted : August 16, 2007
Sponsor:
Information provided by:
GE Healthcare

Brief Summary:
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 or disease Intervention/treatment
Coronary Artery Disease Device: 64 Channel VCT

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2005




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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00350506     History of Changes
Other Study ID Numbers: VCT-001
First Posted: July 10, 2006    Key Record Dates
Last Update Posted: August 16, 2007
Last Verified: August 2007

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