NCT00350506TerminatedNot Applicable
An Open-label, Non-randomized, Multi-center Trial Evaluating the Clinical Applicability, Correlation, and Modeling of Cardiac CT Using 64 Detector Row VCT
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- GE Healthcare
- Enrollment
- 77
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
64 Channel VCT
Experimental
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).
Intervention: 64 Channel VCT (Device)
Investigators
Study Sites (1)
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