Clinical trial NCT03375944: Utilisation of Telemedicine in Optimal Cardiac Rehabilitation Program in Patients After Myocardial Revascularization
Official title: The Use of Modern Telemedicine Technologies in an Innovative Program of Optimal Cardiac Rehabilitation in Patients After Completed Myocardial Revascularization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease With Myocardial Infarction
Keywords: Cardiac tele-rehabilitation, Myocardial revascularization
Lead sponsor: American Heart of Poland
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: All cause mortality
timeFrame: 12 months
measure: All cause mortality
timeFrame: 9 months
Secondary outcomes:
measure: Rate of major adverse coronary and cerebrovascular events (MACCE)
timeFrame: 9 months and 1 year
measure: rate of target vessel failure (TVF)
timeFrame: 9 months and 1 year
measure: cardiac death
timeFrame: 9 months and 1 year
measure: Length of hospital stay
timeFrame: up to 9 months and 1 year
measure: Regression, stabilisation or progression of atherosclerotic plaques
timeFrame: baseline + up to 1 year follow-up
measure: Molecular changes in blood
timeFrame: up to 1 year follow-up
Other outcomes:
Locations:
city: Kedzierzyn Kozle
country: Poland
facility: IV Oddział Kardiologii Inwazyjnej, Elektrostymulacji i Angiologii
state: Lower Silesian
city: Chrzanow
country: Poland
facility: Malopolskie Centrum Sercowo-Naczyniowe
state: Malopolskie
city: Bielsko-Biala
country: Poland
facility: II Oddział Kardiologiczny
state: Upper Silesia
city: Dąbrowa Górnicza
country: Poland
facility: III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
state: Upper Silesia
city: Tychy
country: Poland
facility: X Department of Interventional Cardiology
state: Upper Silesia
Study officials:
affiliation: American Heart of Poland
name: Krzysztof Milewski, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: