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

Pawel Buszman

Status

Unknown

Conditions

Coronary Artery Disease With Myocardial Infarction

Treatments

Other: Rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT03375944

RESTORE2015

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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