Utilisation of Telemedicine in Optimal Cardiac Rehabilitation Program in Patients After Myocardial Revascularization
- Conditions
- Coronary Artery Disease With Myocardial Infarction
- Interventions
- Other: Rehabilitation
- Registration Number
- NCT03375944
- Lead Sponsor
- Pawel Buszman
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description study group Rehabilitation Cardiac supervision and rehabilitation
- Primary Outcome Measures
Name Time Method All cause mortality 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.
- Secondary Outcome Measures
Name Time Method rate of target vessel failure (TVF) 9 months and 1 year TVF defined as composite of death, myocardial infarction or target vessel revascularization
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)
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,
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
Trial Locations
- Locations (5)
Malopolskie Centrum Sercowo-Naczyniowe
🇵🇱Chrzanow, Malopolskie, Poland
II Oddział Kardiologiczny
🇵🇱Bielsko-Biala, Upper Silesia, Poland
X Department of Interventional Cardiology
🇵🇱Tychy, Upper Silesia, Poland
IV Oddział Kardiologii Inwazyjnej, Elektrostymulacji i Angiologii
🇵🇱Kedzierzyn Kozle, Lower Silesian, Poland
III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
🇵🇱Dąbrowa Górnicza, Upper Silesia, Poland