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

Coronary Artery Disease With Myocardial Infarction Clinical Trial

— RESTORE  

Official title:

The Use of Modern Telemedicine Technologies in an Innovative Program of Optimal Cardiac Rehabilitation in Patients After Completed Myocardial Revascularization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03375944
• Other study ID #: RESTORE2015
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2018
• Est. completion date: July 2020

Study information

• Verified date: May 2018
• Source: American Heart of Poland
• Contact: Krzysztof Milewski, MD PhD
• Phone: 0048609109131
• Email: kpmilewski[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease With Myocardial Infarction
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Poland	II Oddzial Kardiologiczny	Bielsko-Biala	Upper Silesia
Poland	Malopolskie Centrum Sercowo-Naczyniowe	Chrzanow	Malopolskie
Poland	III Oddzial Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii	Dabrowa Górnicza	Upper Silesia
Poland	IV Oddzial Kardiologii Inwazyjnej, Elektrostymulacji i Angiologii	Kedzierzyn Kozle	Lower Silesian
Poland	X Department of Interventional Cardiology	Tychy	Upper Silesia

Sponsors (1)

Lead Sponsor	Collaborator
Pawel Buszman

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	rate of target vessel failure (TVF)	TVF defined as composite of death, myocardial infarction or target vessel revascularization	9 months and 1 year
Secondary	cardiac death	all cause and cardiac death will be recorded	9 months and 1 year
Secondary	Length of hospital stay	total hospital length will be recorded	up to 9 months and 1 year
Secondary	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
Secondary	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