Utilisation of Telemedicine in Optimal Cardiac Rehabilitation Program in Patients After Myocardial Revascularization
NCT ID: NCT03375944
Last Updated: 2018-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1000 participants
INTERVENTIONAL
2018-03-28
2020-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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control group
Cardiac supervision
No interventions assigned to this group
study group
Cardiac supervision and rehabilitation
Rehabilitation
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.
Interventions
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Rehabilitation
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Pawel Buszman
OTHER
Responsible Party
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Pawel Buszman
Chief Executive Officer
Principal Investigators
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Krzysztof Milewski, MD PhD
Role: PRINCIPAL_INVESTIGATOR
American Heart of Poland
Locations
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Malopolskie Centrum Sercowo-Naczyniowe
Chrzanów, Lesser Poland Voivodeship, Poland
IV Oddział Kardiologii Inwazyjnej, Elektrostymulacji i Angiologii
Kedzierzyn Kozle, Lower Silesian Voivodeship, Poland
II Oddział Kardiologiczny
Bielsko-Biala, Upper Silesia, Poland
III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
Dąbrowa Górnicza, Upper Silesia, Poland
X Department of Interventional Cardiology
Tychy, Upper Silesia, Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RESTORE2015
Identifier Type: -
Identifier Source: org_study_id
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