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

General Electric (GE)

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: 64 Channel VCT

Study type: Interventional

Funder types: Industry

Identifiers

NCT00348569

GE-189-002

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 with typical or atypical chest pain suspected of coronary artery disease (CAD).

Enrollment: 245 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

245 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 2 to 21 days later by catheter coronary angiography (CATH).

Treatment:

Device: 64 Channel VCT