Coronary Artery Disease With Myocardial Infarction
Conditions
Keywords
Cardiac tele-rehabilitation, Myocardial revascularization
Brief summary
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.
Detailed description
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.
Interventions
OTHERRehabilitation
The purpose of this work package is to evaluate short- and long-term clinical effects of optimal, continuous and regularly controlled tele-rehabilitation, which is based on exercise training, intensive dietary and educational program focused on lifestyle and risk factors modification. The main expectations of OCR is to normalize annual mortality to the level of the low risk healthy population.
Sponsors
Pawel Buszman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality | 12 months | The primary objective of the study is to compare the all cause mortality between the control and the study group during the annual follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of target vessel failure (TVF) | 9 months and 1 year | TVF defined as composite of death, myocardial infarction or target vessel revascularization |
| cardiac death | 9 months and 1 year | all cause and cardiac death will be recorded |
| Rate of major adverse coronary and cerebrovascular events (MACCE) | 9 months and 1 year | MACCE defined as either: any cause death, repeat revascularization, myocardial infarction and stroke at 1 year follow-up, |
| Regression, stabilisation or progression of atherosclerotic plaques | baseline + up to 1 year follow-up | Measured in coronary arteries with the use of IVUS/NIRS (Intravascular Ultrasound / Near-infrared spectroscopy) |
| Molecular changes in blood | up to 1 year follow-up | Multiple molecular parameters will be measured at baseline and at 9-12 months follow-up |
| Length of hospital stay | up to 9 months and 1 year | total hospital length will be recorded |
Countries
Poland
Contacts
Primary ContactKrzysztof Milewski, MD PhD
Backup ContactDominika Baron, MSc
Outcome results
None listed