Value of Cardiac Rehabilitation on the Treatment of Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- first occurrence of major adverse cardiovascular events (MACE)
研究概览
简要总结
Cardiac rehabilitation is a valuable treatment for patients with a broad spectrum of cardiac disease. Current guidelines support its use in patients after acute coronary syndrome, coronary artery bypass grafting, coronary stent placement, valve surgery, and stable chronic systolic heart failure. Its use in these conditions is supported by a robust body of research demonstrating improved clinical outcomes. Despite this evidence, cardiac rehabilitation referral and attendance remains low and interventions to increase its use need to be developed.
详细描述
The trial was conducted in Shenzhen in China. This study will recruit 100 patients with cardiovascular disease with a median and minimum follow-up of 24 and 6 months. Patients will be individually randomized to receive either a cardiac rehabilitation program (n = 50) or enhanced standard care involving educational advice (n = 50). The co-primary outcomes are: 1) first occurrence of major adverse cardiovascular events (MACE) (composite of all-cause mortality, myocardial infarction, stroke, or emergency cardiovascular hospitalization); and 2) self-rated health on the Quality of Life-5 Dimensions-5 Level visual analogue scale.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cardiovascular disease
排除标准
- •Incalculable TFC
- •Coronary artery spasm or ectasia
- •LV ejection fraction < 52% in males or < 54% in females
- •Abnormal heart structure (congenital heart disease, cardiomyopathies, or valvular dysfunction)
- •Pericardial disease (pericardial effusion or constrictive pericarditis)
- •Previous history of myocardial infarction
- •Uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 105 mmHg)
- •Hyperthyroidism
- •Hypothyroidism
- •Malignancy
- •Autoimmune disease
- •Infection
- •Pulmonary, hepatic, and renal disorders
- •Haematological disorders (anaemia, bone marrow involved by neoplastic disease, or red blood cell transfusions)
结局指标
主要结局
first occurrence of major adverse cardiovascular events (MACE)
时间窗: 3 years
first occurrence of major adverse cardiovascular events (MACE) (composite of all-cause mortality, myocardial infarction, stroke, or emergency cardiovascular hospitalization)
maximum oxygen uptake
时间窗: 3 years
maximum oxygen uptake
次要结局
未报告次要终点