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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease With Myocardial Infarction
• Intervention / Treatment: Other: Rehabilitation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Lower Silesian
    • Kedzierzyn Kozle, Lower Silesian, Poland, 47-200
      • Active, not recruiting
      • IV Oddział Kardiologii Inwazyjnej, Elektrostymulacji i Angiologii
  • Malopolskie
    • Chrzanow, Malopolskie, Poland, 32-500
      • Active, not recruiting
      • Malopolskie Centrum Sercowo-Naczyniowe
  • Upper Silesia
    • Bielsko-Biala, Upper Silesia, Poland, 43-316
      • Active, not recruiting
      • II Oddział Kardiologiczny
    • Dąbrowa Górnicza, Upper Silesia, Poland, 41-300
      • Active, not recruiting
      • III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
    • Tychy, Upper Silesia, Poland, 43-100
      • Recruiting
      • X Department of Interventional Cardiology
      • Contact: Adam Janas, MD, PhD; Phone Number: 0048602332935; Email: adamjjanas@gmail.com
      • Contact: Maria Jarnot; Phone Number: 0048509658798; Email: maria.jarnot@ahop.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; Cardiac supervision
Other: study group; Cardiac supervision and rehabilitation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Pawel Buszman
• Investigators: Principal Investigator: Krzysztof Milewski, MD PhD, American Heart of Poland

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 28, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Cardiac tele-rehabilitation, Myocardial revascularization
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease
• Other Study ID Numbers: RESTORE2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No