Coronary Artery Disease With Myocardial InfarctionRESTORENCT03375944
Utilisation of Telemedicine in Optimal Cardiac Rehabilitation Program in Patients After Myocardial Revascularization
A study testing Rehabilitation in people with Coronary Artery Disease With Myocardial Infarction, run by Pawel Buszman at 5 sites in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronary Artery Disease With Myocardial Infarction
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 5 sitesPoland
- Study dates
- 28 Mar 2018to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Poland5 sites, 1 recruiting
- Active, not recruiting
II Oddział Kardiologiczny
Bielsko-Biala, Upper Silesia, 43-316
- Active, not recruiting
Malopolskie Centrum Sercowo-Naczyniowe
Chrzanów, Lesser Poland Voivodeship, 32-500
- Active, not recruiting
III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
Dąbrowa Górnicza, Upper Silesia, 41-300
- Active, not recruiting
IV Oddział Kardiologii Inwazyjnej, Elektrostymulacji i Angiologii
Kedzierzyn Kozle, Lower Silesian Voivodeship, 47-200
- Recruiting
X Department of Interventional Cardiology
Tychy, Upper Silesia, 43-100
Adam Janas, MD, PhD, 0048602332935, adamjjanas@gmail.com
Maria Jarnot, 0048509658798, maria.jarnot@ahop.pl
About this study
Official title: 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.
Read the 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.
- Being tested
- Rehabilitation
- Keywords
- Cardiac tele-rehabilitation, Myocardial revascularization
- Medical subject headings
- Coronary Artery Disease, Autosomal Dominant, 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
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 | Role | What they receive |
|---|---|---|
| control group | No intervention | Cardiac supervision |
| study group | Other | Cardiac supervision and rehabilitation Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 9 months
Secondary outcomes (6)
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,
Measured: 9 months and 1 year
rate of target vessel failure (TVF)
TVF defined as composite of death, myocardial infarction or target vessel revascularization
Measured: 9 months and 1 year
cardiac death
all cause and cardiac death will be recorded
Measured: 9 months and 1 year
Length of hospital stay
total hospital length will be recorded
Measured: 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)
Measured: 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
Measured: up to 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start28 Mar 2018
- Primary completionDec 2019 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease With Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pawel Buszman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pawel Buszman, American Heart of Poland
- Investigators
- Krzysztof Milewski, MD PhD, Principal investigator, American Heart of Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375944
- Sponsor's protocol ID
- RESTORE2015
- Acronym
- RESTORE
- Status last verified
- May 2018
- First submitted
- 12 Dec 2017
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Modern Telemedicine Technologies in an Innovative Program of Optimal Cardiac Rehabilitation in Patients After Completed Myocardial Revascularization
- ClinicalTrials.gov ID
- NCT03375944
- Acronym / sponsor ID
- RESTORE / RESTORE2015
- Keywords
- Cardiac tele-rehabilitation, Myocardial revascularization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Pawel BuszmanUniversity, hospital or other
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Cardiac supervision |
| study group | Other | Other: RehabilitationCardiac supervision and rehabilitation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehabilitationThe 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. | Other | study group |
Primary outcome
All cause mortality
Time frame: 12 months
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
Time frame: 9 months
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.
6 secondary outcomes
Rate of major adverse coronary and cerebrovascular events (MACCE)
Time frame: 9 months and 1 year
rate of target vessel failure (TVF)
Time frame: 9 months and 1 year
cardiac death
Time frame: 9 months and 1 year
Length of hospital stay
Time frame: up to 9 months and 1 year
Regression, stabilisation or progression of atherosclerotic plaques
Time frame: baseline + up to 1 year follow-up
Molecular changes in blood
Time frame: up to 1 year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krzysztof Milewski, MD PhD principal investigator
American Heart of Poland
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Coronary Artery Disease With Myocardial Infarction, run by Pawel Buszman at 5 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Krzysztof Milewski, MD PhD (0048609109131, kpmilewski@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.