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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | Cardiac supervision | |
| study group | Other | Cardiac supervision and rehabilitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation | Other | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Krzysztof Milewski, MD PhD | Contact | 0048609109131 | kpmilewski@gmail.com | |
| Dominika Baron, MSc | Contact | 0048502470630 | dominika.baron@ahop.pl |
| Name | Affiliation | Role |
|---|---|---|
| Krzysztof Milewski, MD PhD | American Heart of Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malopolskie Centrum Sercowo-Naczyniowe | Active, not recruiting | Chrzanów | Lesser Poland Voivodeship | 32-500 | Poland | |
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| ID | Term |
|---|---|
| C564258 | Coronary Artery Disease, Autosomal Dominant, 1 |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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|
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 |
| IV Oddział Kardiologii Inwazyjnej, Elektrostymulacji i Angiologii |
| Active, not recruiting |
| Kedzierzyn Kozle |
| Lower Silesian Voivodeship |
| 47-200 |
| Poland |
| II Oddział Kardiologiczny | Active, not recruiting | Bielsko-Biala | Upper Silesia | 43-316 | Poland |
| III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii | Active, not recruiting | Dąbrowa Górnicza | Upper Silesia | 41-300 | Poland |
| X Department of Interventional Cardiology | Recruiting | Tychy | Upper Silesia | 43-100 | Poland |
|
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |