Utilisation of Telemedicine in Optimal Cardiac Rehabilitation Program in Patients After Myocardial Revascularization

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Use of Modern Telemedicine Technologies in an Innovative Program of Optimal Cardiac Rehabilitation in Patients After Completed Myocardial Revascularization

Conditions
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Coronary Artery Disease With Myocardial Infarction

Intervention / Treatment
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* Other: Rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>Cardiac supervision | |
| Other: study group<br>Cardiac supervision and rehabilitation | Other: Rehabilitation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | 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. | 12 months | 
| All cause mortality | 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. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of major adverse coronary and cerebrovascular events (MACCE) | MACCE defined as either: any cause death, repeat revascularization, myocardial infarction and stroke at 1 year follow-up, | 9 months and 1 year | 
| rate of target vessel failure (TVF) | TVF defined as composite of death, myocardial infarction or target vessel revascularization | 9 months and 1 year | 
| cardiac death | all cause and cardiac death will be recorded | 9 months and 1 year | 
| Length of hospital stay | total hospital length will be recorded | up to 9 months and 1 year | 
| Regression, stabilisation or progression of atherosclerotic plaques | Measured in coronary arteries with the use of IVUS/NIRS (Intravascular Ultrasound / Near-infrared spectroscopy) | baseline + up to 1 year follow-up | 
| Molecular changes in blood | Multiple molecular parameters will be measured at baseline and at 9-12 months follow-up | up to 1 year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac tele-rehabilitation, Myocardial revascularization