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临床试验/NCT07465692
NCT07465692进行中(未招募)不适用

Long-term Results of Rehabilitation of Patients With Myocardial Infarction After Endovascular Intervention on Coronary Arteries at the Outpatient Stage. Register

National Medical Research Center for Therapy and Preventive Medicine0 个研究点目标入组 1,046 人开始时间: 2013年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,046
主要终点
Combined

研究概览

简要总结

Endovascular intervention is one of the most effective treatment for acute coronary syndrome. Therefore, studying the impact of various medical rehabilitation programs on the course of coronary heart disease, patient quality of life, restenosis, and prognosis is of scientific and practical interest. Medical rehabilitation is a crucial stage in patient care after myocardial revascularization. Regular moderate-intensity physical activity helps improve endothelial function and has anti-inflammatory and antithrombogenic effects. Improving a patient's prognosis after myocardial infarction depends on the duration and intensity of cardiac rehabilitation programs, as well as the patient's motivation. Therefore, this issue requires further study, particularly in patients who have undergone endovascular interventions on coronary arteries.

详细描述

The study was an interventional (clinical) trial, randomized in parallel groups. A total of 1,046 patients were included.

A total of 1,046 patients of both sexes were randomized into two groups. Group 1 (control) patients received standard therapy required for patients undergoing coronary artery stenting during the acute phase of myocardial infarction. They continued their usual physical activity and attended a school for patients with myocardial infarction. Group 2 patients received standard therapy required for patients undergoing coronary artery stenting during the acute phase of myocardial infarction, attended a school for patients with myocardial infarction, and participated in a physical training program. The training program lasted over four months. Postoperatively, patients underwent blood tests, echocardiography, ECG, and bicycle ergometry. The next visit was performed after an average of eight years (with a maximum follow-up period of 11 years). Cardiovascular events were assessed at this stage. Patients who were unable to attend the clinic were interviewed by telephone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute myocardial infarction, coronary artery stenting

排除标准

  • Age (younger 18 years, older 75 years)

研究组 & 干预措施

Physical training

Experimental

Integrated Rehabilitation consisting of exercise training and school for patients

干预措施: Physical training program (Other)

Control

No Intervention

Standard follow-up and attending school for patients at the participating heart center

结局指标

主要结局

Combined

时间窗: 20 years

Cardiovascular mortality, non-fatal acute myocardial infarction, non-fatal stroke, need for revascularization

次要结局

  • cardiovascular mortality(20 years)
  • myocardial infarction(20 years)
  • All-cause mortality(20 years)
  • stroke(20 years)
  • need for revascularization(20 years)
  • Composite endpoint of major adverse cardiovascular events (MACE)(20 years)
  • hospitalization due to cardiovascular complications(20 years)

研究者

申办方类型
Other Gov
责任方
Sponsor

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