The Impact of Phase I Cardiac Rehabilitation on the Prognosis of Acute Myocardial Infarction (AMI) Patients After Percutaneous Coronary Intervention (PCI): A Single-Center, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- Seattle Angina Questionnaire (SAQ)
研究概览
简要总结
Previous research has confirmed that patients undergoing percutaneous coronary intervention (PCI) can benefit from cardiac rehabilitation programs. However, there is a paucity of studies on Phase I cardiac rehabilitation commenced within three days following PCI in patients with acute myocardial infarction (AMI). Consequently, the objective of the study is to demonstrate whether Phase I cardiac rehabilitation can improve the prognosis at 12 months when compared with the control group. The primary endpoint is the Seattle Angina Questionnaire (SAQ) score at 12 months for the patients. The principal hypothesis of the study is that Phase I cardiac rehabilitation will improve the long-term prognosis for AMI patients at 12 months after PCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Patients with AMI (including STEMI and NSTEMI) who were treated in the CCU (Coronary Care Unit) for more than 12 hours after emergency PCI;
- •Patients who are expected to meet the discharge criteria without the need for repeat PCI during the current hospital stay after PCI;
- •No chest pain episodes within 8 hours, with no recurrence of myocardial infarction; remained hemodynamically stable;
- •No further increase in serum levels of cardiac biomarkers such as Creatine Kinase -MB (CK-MB) and cardiac troponins (cTn).
排除标准
- •Patients with Killip class III or higher, or symptoms and signs of acute pulmonary edema and respiratory distress;
- •Malignant arrhythmias that cause hemodynamic instability and potentially life-threatening conditions;
- •Mechanical lesions such as ventricular wall rupture, valve or tendon rupture;
- •Patients who have not yet been weaned off ECMO, IABP, temporary pacemakers, CRRT;
- •Patients with liver or kidney dysfunction (transaminase exceeded three times the upper limit of normal; EGFR<30 ml/(min·1.73m^2)) or advanced malignant tumors;
- •Patients who cannot undergo exercise rehabilitation due to orthopedic or psychiatric diseases;
- •Patients with language impairment;
- •Patients currently undergoing systematic training or participating in other clinical trials without reaching the primary endpoint collection time;
- •Researchers believe that patients are not suitable for participation in this study or have not obtained an informed consent form.
结局指标
主要结局
Seattle Angina Questionnaire (SAQ)
时间窗: 6-month and 12-month
Seattle Angina Questionnaire Score (from 0 to 500) higher scores mean a better outcome. The assessment consists of five specific dimensions, with each dimension scored on a scale ranging from 0 to 100. 1. Degree of physical activity limitation. 2. Stable angina status. 3. Frequency of angina attacks. 4. Satisfaction with treatment. 5. Level of disease awareness.
次要结局
- 6 minutes walking distance(6-month and 12-month)
- Left ventricular ejection fraction(6-month)
- MACCE(12-month)
研究者
Han Yaling, MD
Chief Physician
Shenyang Northern Hospital