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

General Electric (GE)

Status: Terminated

Conditions: Coronary Artery Disease

Treatments: Device: 64 Channel VCT

Study type: Interventional

Funder types: Industry

Identifiers

NCT00350506

VCT-001

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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77 participants in 1 patient group

64 Channel VCT

Experimental group

Description:

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).

Treatment:

Device: 64 Channel VCT