Acute Myocardial InfarctionNCT04161378
Impact of Cardiac Rehabilitation Programs on Left Ventricular Remodeling After Acute Myocardial Infarction - the REHAB Trial
An observational study of Acute Myocardial Infarction and Non-ST Elevation Myocardial Infarction, run by Cardio Med Medical Center at 1 site in Romania.
Trial summary
The aim of REHAB trial is to investigate the impact of early mobilization after AMI in reducing left ventricular remodeling, as assessed by cardiac magnetic resonance imaging. At the same time, the study aims to demonstrate the contribution of early mobilization to reduction of: systemic inflammation in the immediate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Non-ST Elevation Myocardial Infarction, Systemic Inflammation
- What is being tested?
- Cardiac imaging and Laboratory analysis
- How many people
- 100 participants
- Where
- 1 siteRomania
- Study dates
- 10 Jan 2020to 30 Nov 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 patients with AMI, presenting with either ST-segment elevation acute myocardial infarction (STEMI) or non-ST-segment elevation AMI (NSTEMI).
Who may be able to join
- Patients with AMI in the last 12 hours;
- Successful revascularization of the culprit artery within the first 12 hours after the onset of symptoms in STEMI or within first 48 hours in NSTEMI (according to the risk class);
- Signed written informed consent.
Who cannot join
- Patient refusal;
- Any condition that would contraindicate CMR examination;
- Women during pregnancy or lactation period;
- Women able to procreate without any contraceptive usage;
- Chronic kidney disease (glomerular filtration rate <60ml/min/1.73m2) or acute renal injury that requires hemodialysis;
- Any type of neoplasia documented in the last 3 years before randomization;
- Expectation of life < 1 year.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of REHAB trial is to investigate the impact of early mobilization after AMI in reducing left ventricular remodeling, as assessed by cardiac magnetic resonance imaging. At the same time, the study aims to demonstrate the contribution of early mobilization to reduction of: systemic inflammation in the immediate post infarction phase, complication rates and mortality, in patients who had suffered a recent AMI, for a 1 year follow-up period.
Read the detailed description
While the role of early mobilization in the immediate postinfarction period has been well demonstrated, little is known in present about the link between early mobilization and reduction of systemic inflammation. At the same time, the impact of early mobilization on regression of left ventricular remodeling has not been elucidated so far.
The study will be a single-center, observational, non-randomized study, which will be carried out in the Center of Advanced Research in Multimodal Cardiac Imaging Cardiomed, including 100 patients with AMI, presenting with either ST-segment elevation acute myocardial infarction (STEMI) or non-ST-segment elevation AMI (NSTEMI). According to the moment of mobilization after AMI patients will be distributed in two groups: group 1 - patients with early mobilization (<2 days after the onset of symptoms), and group 2 - subjects with delayed mobilization after AMI (>2 days after the onset of symptoms).
Each patient will be evaluated in terms of systemic inflammatory status in the immediate postinfarction phase, at baseline and at 7 days after AMI. In order to assess ventricular function and remodeling, extent of myocardial scar and transmurality index, late gadolinium enhancement CMR will be performed for each patient.
The study will be conducted over a period of 2 years, in which patients will be examined at baseline, and will be followed-up for 1 year for occurrence of MACE.
All patients will sign an informed written consent prior to study enrollment.
Study objectives:
Primary: to evaluate the impact of early mobilization after AMI on the ventricular remodeling in the post-infarction period, as assessed by CMR imaging. Secondary: to assess the rate of in-hospital mortality and the rate of repeated revascularization or MACE (including cardiovascular death or stroke) in patients with early mobilization as compared to those with delayed mobilization, and the effect of early mobilization on systemic inflammation in the immediate postinfarction phase.
Study Timeline:
- Baseline (day 0):
- Achieve written informed consent form all patients
- Check all inclusion/exclusion criteria
- Record demographic information, medical records, cardiovascular risk factors
- Perform and record physical examination and 12-lead ECG
- Laboratory analysis (CBC, routine biochemistry, inflammatory biomarkers, acute adhesion molecules)
- Transthoracic echocardiography / speckle tracking
- Visit 1 (day 7 / discharge from the hospital):
- hs-CRP assessment
- Visit 2 (month 1):
- LGE-CMR (myocardial fibrosis/scar, infarct size, transmurality, remodeling)
- Visit 3,4,5 (month 3,6,9):
- Record results of physical exam, medical records, ECG
- Transthoracic echocardiography / speckle tracking
- Final study visit (month 12):
- Record results of physical exam, medical records, ECG
- Transthoracic echocardiography / speckle tracking
- End-point assessment
Study procedures:
- Medical records, physical exam;
- Laboratory analysis (complete blood count, biochemistry, serum levels of hs-CRP, MMPs, IL6, NT-pro-BNP);
- Electrocardiography
- Transthoracic echocardiography for assessment of left ventricular systolic and diastolic performance, speckle tracking echocardiography, Dobutamine viability test
- Late gadolinium enhancement CMR for evaluation of ventricular function and remodeling, extent of myocardial scar and transmurality index.
- Conditions
- Acute Myocardial Infarction, Non-ST Elevation Myocardial Infarction, Systemic Inflammation, Ventricular Remodeling, Acute Coronary Syndrome
- Being tested
- Cardiac imaging, Laboratory analysis
- Medical subject headings
- Non-ST Elevated Myocardial Infarction, Ventricular Remodeling, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac imagingDiagnostic test
- Transthoracic echocardiography
- Late gadolinium enhancement CMR
Laboratory analysisDiagnostic test
- complete blood count
- biochemistry
- hs-CRP, MMPs, IL6, NT-pro-BNP
| Study group | Role | What they receive |
|---|---|---|
| RHB-SG 01 | Patients with early mobilization (< 2 days after the onset of symptoms) Receives: Diagnostic Test: Cardiac imaging; Diagnostic Test: Laboratory analysis | |
| RHB-SG 02 | Patients with delayed mobilization after AMI (>2 days after the onset of symptoms) Receives: Diagnostic Test: Cardiac imaging; Diagnostic Test: Laboratory analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular remodeling in the post-infarction period
LGE-CMR evaluation for myocardial fibrosis/scar, infarct size, transmurality, remodeling assessment.
Measured: Month 1
Secondary outcomes (2)
Major adverse cardiovascular events
Rate of MACE at follow-up
Measured: 12 months
Systemic inflammation in the immediate postinfarction phase
Inflammatory status evaluation via hs-CRP assessment at baseline and at 7 days from the acute event.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start10 Jan 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardio Med Medical Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures, University Hospital of Targu Mures, Romania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161378
- Sponsor's protocol ID
- CM0121-REHAB
- Status last verified
- Nov 2019
- First submitted
- 28 Oct 2019
- Last updated
- 2 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cardiac Rehabilitation Programs on Left Ventricular Remodeling After Acute Myocardial Infarction - the REHAB Trial
- ClinicalTrials.gov ID
- NCT04161378
- Acronym / sponsor ID
- CM0121-REHAB
- Conditions
- Acute Myocardial Infarction, Non-ST Elevation Myocardial Infarction, Systemic Inflammation, Ventricular Remodeling, Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cardio Med Medical CenterIndustry (pharma, biotech, devices)
- Collaborators
- George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures, University Hospital of Targu Mures, Romania
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 13 Nov 2019 (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.
The aim of REHAB trial is to investigate the impact of early mobilization after AMI in reducing left ventricular remodeling, as assessed by cardiac magnetic resonance imaging. At the same time, the study aims to demonstrate the contribution of early mobilization to reduction of: systemic inflammation in the immediate post infarction phase, complication rates and mortality, in patients who had suffered a recent AMI, for a 1 year follow-up period.
Detailed description
While the role of early mobilization in the immediate postinfarction period has been well demonstrated, little is known in present about the link between early mobilization and reduction of systemic inflammation. At the same time, the impact of early mobilization on regression of left ventricular remodeling has not been elucidated so far.
The study will be a single-center, observational, non-randomized study, which will be carried out in the Center of Advanced Research in Multimodal Cardiac Imaging Cardiomed, including 100 patients with AMI, presenting with either ST-segment elevation acute myocardial infarction (STEMI) or non-ST-segment elevation AMI (NSTEMI). According to the moment of mobilization after AMI patients will be distributed in two groups: group 1 - patients with early mobilization (<2 days after the onset of symptoms), and group 2 - subjects with delayed mobilization after AMI (>2 days after the onset of symptoms).
Each patient will be evaluated in terms of systemic inflammatory status in the immediate postinfarction phase, at baseline and at 7 days after AMI. In order to assess ventricular function and remodeling, extent of myocardial scar and transmurality index, late gadolinium enhancement CMR will be performed for each patient.
The study will be conducted over a period of 2 years, in which patients will be examined at baseline, and will be followed-up for 1 year for occurrence of MACE.
All patients will sign an informed written consent prior to study enrollment.
Study objectives:
Primary: to evaluate the impact of early mobilization after AMI on the ventricular remodeling in the post-infarction period, as assessed by CMR imaging. Secondary: to assess the rate of in-hospital mortality and the rate of repeated revascularization or MACE (including cardiovascular death or stroke) in patients with early mobilization as compared to those with delayed mobilization, and the effect of early mobilization on systemic inflammation in the immediate postinfarction phase.
Study Timeline:
- Baseline (day 0):
- Achieve written informed consent form all patients
- Check all inclusion/exclusion criteria
- Record demographic information, medical records, cardiovascular risk factors
- Perform and record physical examination and 12-lead ECG
- Laboratory analysis (CBC, routine biochemistry, inflammatory biomarkers, acute adhesion molecules)
- Transthoracic echocardiography / speckle tracking
- Visit 1 (day 7 / discharge from the hospital):
- hs-CRP assessment
- Visit 2 (month 1):
- LGE-CMR (myocardial fibrosis/scar, infarct size, transmurality, remodeling)
- Visit 3,4,5 (month 3,6,9):
- Record results of physical exam, medical records, ECG
- Transthoracic echocardiography / speckle tracking
- Final study visit (month 12):
- Record results of physical exam, medical records, ECG
- Transthoracic echocardiography / speckle tracking
- End-point assessment
Study procedures:
- Medical records, physical exam;
- Laboratory analysis (complete blood count, biochemistry, serum levels of hs-CRP, MMPs, IL6, NT-pro-BNP);
- Electrocardiography
- Transthoracic echocardiography for assessment of left ventricular systolic and diastolic performance, speckle tracking echocardiography, Dobutamine viability test
- Late gadolinium enhancement CMR for evaluation of ventricular function and remodeling, extent of myocardial scar and transmurality index.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RHB-SG 01 | – | Diagnostic Test: Cardiac imaging, Diagnostic Test: Laboratory analysisPatients with early mobilization (< 2 days after the onset of symptoms) |
| RHB-SG 02 | – | Diagnostic Test: Cardiac imaging, Diagnostic Test: Laboratory analysisPatients with delayed mobilization after AMI (>2 days after the onset of symptoms) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients with AMI, presenting with either ST-segment elevation acute myocardial infarction (STEMI) or non-ST-segment elevation AMI (NSTEMI).
Key inclusion criteria (3 listed)
- Patients with AMI in the last 12 hours;
- Successful revascularization of the culprit artery within the first 12 hours after the onset of symptoms in STEMI or within first 48 hours in NSTEMI (according to the risk class);
- Signed written informed consent.
Key exclusion criteria (7 listed)
- Patient refusal;
- Any condition that would contraindicate CMR examination;
- Women during pregnancy or lactation period;
- Women able to procreate without any contraceptive usage;
- Chronic kidney disease (glomerular filtration rate <60ml/min/1.73m2) or acute renal injury that requires hemodialysis;
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 |
|---|---|---|
| Cardiac imaging* Transthoracic echocardiography * Late gadolinium enhancement CMR | Diagnostic test | RHB-SG 01, RHB-SG 02 |
| Laboratory analysis* complete blood count * biochemistry * hs-CRP, MMPs, IL6, NT-pro-BNP | Diagnostic test | RHB-SG 01, RHB-SG 02 |
Primary outcome
Ventricular remodeling in the post-infarction period
Time frame: Month 1
LGE-CMR evaluation for myocardial fibrosis/scar, infarct size, transmurality, remodeling assessment.
2 secondary outcomes
Major adverse cardiovascular events
Time frame: 12 months
Systemic inflammation in the immediate postinfarction phase
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction and Non-ST Elevation Myocardial Infarction, run by Cardio Med Medical Center at 1 site in Romania.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventricular remodeling in the post-infarction period (time frame: Month 1). 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 2 Aug 2022.