Chronic Total Occlusive Lesions CMR Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Change in ischemia
研究概览
简要总结
This registry will include consecutive patients presenting with at least one chronic total occlusion on coronary angiogram who will be treated by percutaneous coronary intervention in our center. All patients will undergo a non-invasive assessment for myocardial ischemia/viability using cardiac magnetic resonance (CMR) prior to revascularization therapy. Follow up CMR will be repeated in all participants after three months and one year. Additionally, clinical outcomes and quality of life will be evaluated at baseline and at follow-up. Primary objective of this study is to investigate the the reduction in ischemia (as evaluated by follow-up CMR) and the severity of angina according to clinical evaluation (including Seattle Angina Questionnaires [SAQ], Canadian Class Score[CCS] and 6-mins walking test).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Presence of at least one untreated CTO at basal angiography (defined as a total occlusion in any major coronary vessel or relevant side branches [reference vessel diameter ≥2.5mm or as judged by two independent interventional cardiologists], with TIMI 0 in the distal segment and at least 3 months old
- •Patient has a clinical indication to perform CTO PCI
- •Willing to participate and able to understand, read and sign the informed consent document.
排除标准
- •CMR contraindications
- •Contraindications to adenosine or dobutamine
- •Severe chronic kidney disease (estimated Glomerular Filtration Rate [eGFR] <60 mL/min/1.73m2 or serum creatinine level >2.5 mg/dL)
结局指标
主要结局
Change in ischemia
时间窗: 3 months; 12 months
Parameters of cardiac magnetic resonance
次要结局
- Rate of target lesion failure (TLF).(12 months)
- Changes in angina paramteres(3 months; 12 months)
- Change of left ventricular structure and function(3 months; 12 months)
研究者
Lin Zhao
Associate director of cardiology department
Beijing Anzhen Hospital