NL-OMON49007招募中不适用
REvascularization versus optimal medical therapy on left Ventricular ISchemia reduction: Exploring the associations between ischemia, functional outcome and collaterals in the treatment of Chronic Total Occlusion patients - REVISE-CTO
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 82
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. A chronic total occlusion is present and target lesion. A CTO is required to
- •meet the following characteristics:
- •A 100% luminal narrowing of the coronary artery without antegrade flow, i.e.
- •Thrombolysis in Myocardial Infarction flow grade 0 or 1;
- •Older than 3 months, established with previous PCI or with angiographic
- •characteristics;
- •Amenable to percutaneous revascularization.
- •2. Patient has a clinical indication to perform CTO PCI.
- •3. A SPECT is performed at baseline to assess ischemia and a cardiac magnetic
- •resonance imaging (CMR) scan to assess viability, as part of routine patient
- •care. Patients are deemed eligible for the randomized trial when they meet the
- •ischemic threshold in the CTO territory.
- •The ischemic threshold is defined as:
- •>12.5% of ischemia;
- •With <50% transmural extent of infarction.
- •4. Subject agrees to undergo follow-up SPECT at 6 months after initial inclusion
- •5. Subject is able to verbally confirm understanding and he/she provides
- •written informed consent prior to any Clinical Investigation related procedure,
- •as approved by the appropriate Ethics Committee.
排除标准
- •Subject is younger than 18 years of age;
- •Persistent or permanent atrial fibrillation;
- •Presence of a non-MRI compatible cardiac device, i.e. pacemaker or
- •implantable cardioverter defibrillator;
- •Body weight > 250 kg;
- •Unable to exert, i.e. due to physical disability;
- •Any contraindication for SPECT or CMR, i.e. cerebrovascular clips,
- •claustrophobia;
- •Known renal insufficiency (estimated Glomerular Filtration Rate [eGFR] <60
- •mL/min/1.73m2 or serum creatinine level of >2.5 mg/dL or subject on dialysis);
- •Hypersensitivity or allergy to contrast with inability to properly
- •pre-hydrate;
- •Presence of a comorbid condition with a life expectancy of less than one year;
- •Participation in another trial;
- •Subject is belonging to a vulnerable population (per investigator*s judgment,
- •e.g., subordinate hospital staff) or is unable to read or write.
研究者
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