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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1,000
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.
Malopolskie Centrum Sercowo-Naczyniowe
Chrzanów, Lesser Poland Voivodeship, Poland
ACTIVE_NOT_RECRUITINGIV Oddział Kardiologii Inwazyjnej, Elektrostymulacji i Angiologii
Kedzierzyn Kozle, Lower Silesian Voivodeship, Poland
ACTIVE_NOT_RECRUITINGII Oddział Kardiologiczny
Bielsko-Biala, Upper Silesia, Poland
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.
Time frame: 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.
Time frame: 9 months
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,
Time frame: 9 months and 1 year
rate of target vessel failure (TVF)
TVF defined as composite of death, myocardial infarction or target vessel revascularization
Time frame: 9 months and 1 year
cardiac death
all cause and cardiac death will be recorded
Time frame: 9 months and 1 year
Length of hospital stay
total hospital length will be recorded
Time frame: 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)
Time frame: baseline + up to 1 year follow-up
Molecular changes in blood
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III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
Dąbrowa Górnicza, Upper Silesia, Poland
ACTIVE_NOT_RECRUITINGX Department of Interventional Cardiology
Tychy, Upper Silesia, Poland
RECRUITINGMultiple molecular parameters will be measured at baseline and at 9-12 months follow-up
Time frame: up to 1 year follow-up