NCT00348569已完成不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 2
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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 2 to 21 days later by catheter coronary angiography (CATH).
干预措施: 64 Channel VCT (Device)
研究者
研究点 (2)
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