search
Back to results

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

Primary Purpose

Coronary Artery Disease With Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Rehabilitation
Sponsored by
Pawel Buszman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Disease With Myocardial Infarction focused on measuring Cardiac tele-rehabilitation, Myocardial revascularization

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • IV Oddział Kardiologii Inwazyjnej, Elektrostymulacji i Angiologii
  • Malopolskie Centrum Sercowo-Naczyniowe
  • II Oddział Kardiologiczny
  • III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
  • X Department of Interventional CardiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

control group

study group

Arm Description

Cardiac supervision

Cardiac supervision and rehabilitation

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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,
rate of target vessel failure (TVF)
TVF defined as composite of death, myocardial infarction or target vessel revascularization
cardiac death
all cause and cardiac death will be recorded
Length of hospital stay
total hospital length will be recorded
Regression, stabilisation or progression of atherosclerotic plaques
Measured in coronary arteries with the use of IVUS/NIRS (Intravascular Ultrasound / Near-infrared spectroscopy)
Molecular changes in blood
Multiple molecular parameters will be measured at baseline and at 9-12 months follow-up

Full Information

First Posted
December 12, 2017
Last Updated
May 28, 2018
Sponsor
Pawel Buszman
search

1. Study Identification

Unique Protocol Identification Number
NCT03375944
Brief Title
Utilisation of Telemedicine in Optimal Cardiac Rehabilitation Program in Patients After Myocardial Revascularization
Acronym
RESTORE
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 28, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pawel Buszman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease With Myocardial Infarction
Keywords
Cardiac tele-rehabilitation, Myocardial revascularization

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
Cardiac supervision
Arm Title
study group
Arm Type
Other
Arm Description
Cardiac supervision and rehabilitation
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
All cause mortality
Description
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.
Time Frame
12 months
Title
All cause mortality
Description
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.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Rate of major adverse coronary and cerebrovascular events (MACCE)
Description
MACCE defined as either: any cause death, repeat revascularization, myocardial infarction and stroke at 1 year follow-up,
Time Frame
9 months and 1 year
Title
rate of target vessel failure (TVF)
Description
TVF defined as composite of death, myocardial infarction or target vessel revascularization
Time Frame
9 months and 1 year
Title
cardiac death
Description
all cause and cardiac death will be recorded
Time Frame
9 months and 1 year
Title
Length of hospital stay
Description
total hospital length will be recorded
Time Frame
up to 9 months and 1 year
Title
Regression, stabilisation or progression of atherosclerotic plaques
Description
Measured in coronary arteries with the use of IVUS/NIRS (Intravascular Ultrasound / Near-infrared spectroscopy)
Time Frame
baseline + up to 1 year follow-up
Title
Molecular changes in blood
Description
Multiple molecular parameters will be measured at baseline and at 9-12 months follow-up
Time Frame
up to 1 year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Krzysztof Milewski, MD PhD
Phone
0048609109131
Email
kpmilewski@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dominika Baron, MSc
Phone
0048502470630
Email
dominika.baron@ahop.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krzysztof Milewski, MD PhD
Organizational Affiliation
American Heart of Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
IV Oddział Kardiologii Inwazyjnej, Elektrostymulacji i Angiologii
City
Kedzierzyn Kozle
State/Province
Lower Silesian
ZIP/Postal Code
47-200
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Malopolskie Centrum Sercowo-Naczyniowe
City
Chrzanow
State/Province
Malopolskie
ZIP/Postal Code
32-500
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
II Oddział Kardiologiczny
City
Bielsko-Biala
State/Province
Upper Silesia
ZIP/Postal Code
43-316
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
City
Dąbrowa Górnicza
State/Province
Upper Silesia
ZIP/Postal Code
41-300
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
X Department of Interventional Cardiology
City
Tychy
State/Province
Upper Silesia
ZIP/Postal Code
43-100
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Janas, MD, PhD
Phone
0048602332935
Email
adamjjanas@gmail.com
First Name & Middle Initial & Last Name & Degree
Maria Jarnot
Phone
0048509658798
Email
maria.jarnot@ahop.pl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs