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

Not Applicable

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Device: 64 Channel VCT

• Registration Number: NCT00350506
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-07-06
• Study First Submitted QC: 2006-07-06
• Study First Posted: 2006-07-10
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-26
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
64 Channel VCT	64 Channel VCT	All subjects underwent Coronary Computed Tomographic Angiography (CCTA) after receiving an intravenous (IV) administration of Visipaque (320 mgI/mL), to be followed by catheter coronary angiography (CATH).

Trial Locations

Locations (1)

GE Healthcare; 🇺🇸 Princeton, New Jersey, United States