The Use of Modern Telemedicine Technologies in an Innovative Program of Optimal Cardiac Rehabilitation in Patients After Completed Myocardial Revascularization
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 10
- 主要终点
- All cause mortality
研究概览
简要总结
Although clinical data demonstrate advantages of combining complete revascularization with optimal cardiac rehabilitation (CR) less than one-third of patients in European countries participate in cardiac rehabilitation programs. Therefore, in cooperation with Polish leaders in cardiovascular medicine, rehabilitation and medical software design we aim to introduce and evaluate the system of optimal cardiac telerehabilitation in addition to optimal treatment of coronary artery disease.
详细描述
Although clinical data demonstrate advantages of combining complete revascularization with optimal cardiac rehabilitation (OCR) less than one-third of patients in European countries participate in cardiac rehabilitation programs.
In addition, the major limitations of current CR programs are their short duration without long-term follow-up, lack of appropriate clinical and functional monitoring, and structural problems including geographic misdistribution of available programs. Therefore, in cooperation with Polish leaders in cardiovascular medicine, rehabilitation and medical software design we aim to introduce and evaluate the system of optimal cardiac telerehabilitation in addition to optimal treatment of coronary artery disease. Primarily, the telerehabilitation system will be designed and developed. Secondly, coordinating center will be build and technical tests will be performed in order to evaluate its integrity with telerehabilitation system. Thirdly, the whole system will be validated in clinical settings on patients' population with coronary artery disease and completed revascularization. Finally, procedural steps will be executed in order to prepare the whole system of optimal cardiac telerehabilitation for implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18 and below 70
- •completed revascularization in patients with stable or unstable angina or after myocardial infarction without ST-segment elevation (NSTEMI)
- •in patients with suspected myocardial scars, MRI will be recommended to confirm myocardial viability.
- •eligibility to participate in a program of early cardiac rehabilitation
- •signed informed consent form
- •the ability to use telerehabilitation system
排除标准
- •acute myocardial infarction with ST segment elevation/new onset of left bundle branch block (LBBB),
- •suboptimal (not completed) revascularisation
- •ejection fraction <40%.
- •acute heart failure (Killip IV) at the time of admission to the hospital
- •dual antiplatelet therapy can not be maintained for 1 year after PCI
- •haemorrhagic stroke in the past
- •ischemic stroke or transient ischemia in previous 6 weeks
- •platelet count <100,000 / mm3
- •chronic renal failure with creatinine clearance <30ml / min / 1.73m2
- •planned surgery
- •pregnancy or planned pregnancies
- •expected life expectancy less than 3 years after enrollment
研究组 & 干预措施
control group
Cardiac supervision
study group
Cardiac supervision and rehabilitation
干预措施: Rehabilitation (Other)
结局指标
主要结局
All cause mortality
时间窗: 9 months
The primary objective of the study is to compare the all cause mortality between the control and the study group during the 9-month follow-up.
次要结局
- cardiac death(9 months and 1 year)
- Rate of major adverse coronary and cerebrovascular events (MACCE)(9 months and 1 year)
- rate of target vessel failure (TVF)(9 months and 1 year)
- Regression, stabilisation or progression of atherosclerotic plaques(baseline + up to 1 year follow-up)
- Molecular changes in blood(up to 1 year follow-up)
- Length of hospital stay(up to 9 months and 1 year)
研究者
Pawel Buszman
Chief Executive Officer
American Heart of Poland