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
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014