A New Cardiac Rehabilitation Treatment in the Application of Ischemic Heart Disease: a Prospective, Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from baseline myocardial infarct area at 6 months
研究概览
简要总结
Cardiac rehabilitation is an important link in cardiovascular disease. This study mainly explores the effectiveness of new cardiac rehabilitation therapy (early respiratory rehabilitation, phase I rehabilitation, exercise therapy, external counterpulsation, extracorporeal shock wave, etc.) on patients with ischemic heart disease such as coronary heart disease and heart failure, and the compliance of home rehabilitation compared with traditional cardiac rehabilitation therapy (traditional exercise rehabilitation, rehabilitation education, etc.).
详细描述
This study is a prospective, randomized, controlled study, follow the principle of PICOST design, specific as follows: Participants (the list) : preliminary clinical diagnosis of coronary atherosclerotic heart disease, heart failure. Intervention (Intervention) : conventional drug therapy + new cardiac rehabilitation therapy, a new cardiac rehabilitation treatment reference guide requirements, according to the actual circumstance of patients treated with 1-3 months Intervention. Comparator(control): conventional drug therapy + traditional cardiac rehabilitation therapy. The traditional cardiac rehabilitation therapy referred to domestic and international guidelines and consensus, and used 1 week-3 months of treatment intervention according to the actual situation of patients. Outcome (the end) : the primary end point: D_SPECT examination, were followed up for 6 months to evaluate myocardial perfusion imaging is reduce ischemic area. The secondary end point: 1) the blood biochemical examination and myocardial necrosis markers, etc.; 2) the cardiopulmonary exercise testing: maximum kilograms oxygen uptake and anaerobic threshold when the maximum kilograms oxygen uptake; 3) the major adverse cardiovascular events: cardioascular death, non-fatal myocardial infarction, unplanned coronary artery reconstruction, stroke, heart failure and angina associated hospitalized again; 4) patients family rehabilitation treatment adherence
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 85 years old
- •Female subjects no pregnancy
- •The main admission diagnosis of ischemic heart disease (coronary heart disease, myocardial infarction, ischemic heart failure, etc.)
- •The need for cardiac rehabilitation treatment
排除标准
- •acute respiratory distress syndrome (ARDS);
- •acute episode of COPD;
- •uncontrolled pulmonary infection;
- •acute heart failure; acute pulmonary embolism;
- •acute myocarditis/pericarditis;
- •severe arrhythmia (degree II or III atrioventricular block, atrial flutter, or atrial fibrillation);
- •sternotomy, rib fracture, thoracic deformity, or other neurological diseases that may affect respiratory muscles
结局指标
主要结局
Change from baseline myocardial infarct area at 6 months
时间窗: 1 day of inclusions and 6 months after the first treatment.
The location and extent of myocardial infarction were determined by D-SPECT.
次要结局
- 6 months hemodynamic changes in relative to the baseline(1 day of inclusions and 6 months after the first treatment.)
- Change from baseline peak oxygen consumption at 6 months(1 day of inclusions and 6 months after the first treatment.)
研究者
Ya-Wei Xu
Chief Physician
Shanghai 10th People's Hospital