Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization: Relation to CardioVascular Outcomes, Cost Effectiveness and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- MDDX LLC
- 入组人数
- 1,631
- 试验地点
- 13
- 主要终点
- MACE Endpoints
研究概览
简要总结
To determine the effectiveness, safety, and cost efficiency associated with a CCTA-guided selective catheterization strategy for stable patients but without known CAD and an American Heart Association/ American College of Cardiology Class II indication for non-emergent invasive coronary angiography.
详细描述
A prospective, randomized controlled multicenter trial to determine the clinical and cost effectiveness of a "selective catheterization" strategy versus a "direct catheterization" strategy for stable patients with suspected but without known CAD and clinical indication for non-emergent invasive coronary angiography. Subjects in the "selective catheterization" arm will be followed for a primary endpoint of non-inferiority for rates of major adverse cardiac events (MACE) as compare to subjects in the "direct catheterization" strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Patients providing written informed consent
- •Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography with an ACC/AHA Class II indication
排除标准
- •Known CAD (myocardial infarction, PCI, CABG)
- •ACC/AHA Class I or III indication for ICA
- •Non-cardiac illness with life expectancy <2 years
- •Inability to provide written informed consent
- •Concomitant participation in another clinical trial in which subject is subject to investigational drug or device
- •Pregnant women
- •Allergy to iodinated contrast agent
- •Serum creatinine ≥1.5 mg/dl or Glomerular Filtration Rate <30 ml/min
- •Uncontrolled Baseline irregular heart rhythm (e.g., atrial fibrillation, etc.)
- •Heart rate ≥100 beats per minute
- •Systolic blood pressure ≤90 mm Hg 13) Contraindications to β blockers or nitroglycerin 14) Known complex congenital heart disease 15) Body mass index >35
研究组 & 干预措施
Cardiac CT
Patients who undergo Cardiac CT (instead of Invasive Coronary Angiography)
干预措施: Cardiac CT (Procedure)
Invasive Coronary Angiography
Patients did not undergo Cardiac CT, went straight to Invasive Coronary Angiography
干预措施: Invasive Coronary Angiography (Procedure)
结局指标
主要结局
MACE Endpoints
时间窗: 1 year
* Death * Non-fatal myocardial infarction * Unstable angina (including new onset angina or those requiring hospitalization, revascularization or that are troponin-positive) * Stroke * Urgent or emergent coronary revascularization * Cardiovascular hospitalization (including for angina, heart failure or other)
次要结局
- Additional MACE Endpoints(1 year)