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

NCT03375944 | Unknown DMC

• 1 other identifier: RESTORE2015
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 5

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.

Conditions

Coronary Artery Disease With Myocardial Infarction

Keywords

Cardiac tele-rehabilitation, Myocardial revascularization

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Rate of major adverse coronary and cerebrovascular events (MACCE)

  9 months and 1 year

• rate of target vessel failure (TVF)

  9 months and 1 year

• cardiac death

  9 months and 1 year

• Length of hospital stay

  up to 9 months and 1 year

• Regression, stabilisation or progression of atherosclerotic plaques

  baseline + up to 1 year follow-up

Study Arms (2)

control group

NO INTERVENTION

Cardiac supervision

study group

OTHER

Cardiac supervision and rehabilitation

Other: Rehabilitation

Interventions

Rehabilitation OTHER

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.

study group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pawel Buszman: lead

Study Sites (5)

Malopolskie Centrum Sercowo-Naczyniowe

Chrzanów, Lesser Poland Voivodeship, 32-500, Poland

ACTIVE NOT RECRUITING

IV Oddział Kardiologii Inwazyjnej, Elektrostymulacji i Angiologii

Kedzierzyn Kozle, Lower Silesian Voivodeship, 47-200, Poland

ACTIVE NOT RECRUITING

II Oddział Kardiologiczny

Bielsko-Biala, Upper Silesia, 43-316, Poland

ACTIVE NOT RECRUITING

III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii

Dąbrowa Górnicza, Upper Silesia, 41-300, Poland

ACTIVE NOT RECRUITING

X Department of Interventional Cardiology

Tychy, Upper Silesia, 43-100, Poland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease, Autosomal Dominant, 1

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Krzysztof Milewski, MD PhD

  American Heart of Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krzysztof Milewski, MD PhD

CONTACT

0048609109131; kpmilewski@gmail.com

Dominika Baron, MSc

CONTACT

0048502470630; dominika.baron@ahop.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Executive Officer

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 18, 2017
• Study Start: March 28, 2018
• Primary Completion: December 1, 2019
• Study Completion: July 1, 2020
• Last Updated: May 30, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (5)