A Study of Computed Tomography (CT) for Evaluation of Coronary Artery Blockages in Typical or Atypical Chest Pain

Study Overview
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Brief Summary
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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).

Official Title
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A Prospective, Multicenter Study of GE LightSpeed Volume Computed Tomography (CT) for Evaluation of Coronary Artery Blockages in Typical or Atypical Chest Pain Patients Suspected of Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: 64 Channel VCT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 64 Channel VCT<br>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). | Device: 64 Channel VCT<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CT, Coronary, Cardiac, Angiography, X-ray, CAD, Chest pain