The Influence of Coronary Chronic Total Occlusion on Myocardial Perfusion on Dual-energy Computed Tomography (COPACABANA Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Feasibility of stress computed tomography perfusion imaging for myocardial ischemia assessment in patients with a coronary chronic total occlusion
研究概览
简要总结
The COPACABANA study is designed as a single-centre, open, prospective trial aimed to assess the influence of coronary chronic total occlusion (CTO) on downstream myocardial ischemia via the novel computed tomography perfusion (CTP) imaging technique. To this end, consecutive patients with CTO of a major coronary artery scheduled to undergo percutaneous recanalization of occluded coronary artery based on clinical grounds, will undergo stress CTP using state-of-the-art dual-energy CT scanner at 2 time points (before and 3 months after successful restoration of flow in the CTO vessel).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •delivery of an informed consent and compliance with study protocol
- •persistent angina pectoris (CCS class ≥2) refractory to optimal medical therapy
- •CTO of a major coronary artery (left anterior descending artery, right coronary artery, left circumflex artery) of at least 2.5 mm vessel diameter confirmed by invasive angiography
- •preserved left ventricular ejection fraction (>50%) on echocardiography or cardiac magnetic resonance with preserved contractility in the CTO territory (normokinesia and/or hypokinesia)
排除标准
- •unstable angina and/or myocardial infarction
- •prior myocardial infarction within 4 weeks before study enrolment
- •occurrence of myocardial infarction and/or unplanned revascularization between the index procedure and post-procedural CTP study
- •impaired renal function (eGFR ≤45 ml/min/m2)
- •contraindications to antiplatelet therapy and/or heparin
- •other contraindications to CTP (pregnancy, allergy to contrast media or pharmacologic stress agents, tachyarrhythmia, claustrophobia)
结局指标
主要结局
Feasibility of stress computed tomography perfusion imaging for myocardial ischemia assessment in patients with a coronary chronic total occlusion
时间窗: 1 day
Feasibility of a fast, reliable and safe evaluation of myocardial ischemia in patients with CTO using state-of-the-art computed tomography scanner (SOMATOM® Force) with a dual-energy stress myocardial perfusion imaging protocol in order to obtain in-depth knowledge of the underlying conditions and characteristics of this phenomenon.
Evaluation of myocardial ischemia using stress computed tomography perfusion imaging in patients with a coronary chronic total occlusion
时间窗: 1 day
Qualitative and quantitative assessment of myocardial ischemia using stress computed tomography perfusion imaging in patients with a coronary chronic total occlusion.
次要结局
- Change in myocardial perfusion between baseline (pre-procedural) and follow-up (post-procedural) stress computed tomography perfusion study after successful recanalization of the chronically occluded coronary artery(1 day and 3 months)
- Radiation dose associated with computed tomography perfusion study in patients with a coronary chronic total occlusion(1 day and 3 months)
- Contrast volume associated with computed tomography perfusion study in patients with a coronary chronic total occlusion(1 day and 3 months)