A Study of Computed Tomography (CT) for Evaluation of Coronary Artery Blockages in Typical or Atypical Chest Pain
Not Applicable
Completed
- Conditions
- Coronary Artery Disease
- Interventions
- Device: 64 Channel VCT
- Registration Number
- NCT00348569
- 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 with typical or atypical chest pain suspected of coronary artery disease (CAD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 245
Inclusion Criteria
- The subject has typical or atypical chest pain suspected of CAD and is referred for an elective coronary angiography.
- The subject must be scheduled to undergo a CATH procedure between 48 hours and 3 weeks post CCTA procedure.
- The subject must not undergo any cardiac interventional treatment between the 2 procedures.
- The subject must have sinus rhythm with stable heart rate of ≤65 beats per minute (bpm) or if heart rate was >65 bpm, the subject must agree to the use of beta-blocker(s) prior to the CT scan procedure to achieve stable heart rate of ≤65 bpm.
Exclusion Criteria
- The subject had an established diagnosis of CAD by a) previous CATH, b) prior myocardial infarction confirmed by ECG, or c) prior revascularization (balloon angioplasty, stent placement, or CABG).
- The subject had a known allergy to iodinated contrast agent, including but not limited to hives, anaphylactoid or cardiovascular reactions, laryngeal edema and bronchospasm.
- The subject had impaired renal function with a serum creatinine level of 1.7 mg/dL (150 μmol/L) or above.
- The subject had atrial fibrillation/flutter or any irregular heart rhythm considered by the investigator to interfere with temporal acquisition of cardiac CT images.
- The subject had a resting heart rate of >100 bpm and/or a resting systolic blood pressure of <100mm Hg.
- The subject had an artificial heart valve(s).
- The subject has had prior pacemaker or internal defibrillator lead implantation.
- The subject's resting heart rate was >65 bpm and beta-blocker therapy was contraindicated.
- The subject had a contraindication to verapamil when beta-blocker therapy could not be administered. The subject had a contraindication to nitroglycerin.
- The subject had evidence of ongoing or active clinical instability.
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 2 to 21 days later by catheter coronary angiography (CATH).
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Robert Centofanti, MS
🇺🇸Princeton, New Jersey, United States