Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures | OTHER |
| University Hospital of Targu Mures, Romania | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Study procedures:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RHB-SG 01 | Patients with early mobilization (< 2 days after the onset of symptoms) |
| |
| RHB-SG 02 | Patients with delayed mobilization after AMI (>2 days after the onset of symptoms) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac imaging | Diagnostic Test |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Ventricular remodeling in the post-infarction period | LGE-CMR evaluation for myocardial fibrosis/scar, infarct size, transmurality, remodeling assessment. | Month 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular events | Rate of MACE at follow-up | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
100 patients with AMI, presenting with either ST-segment elevation acute myocardial infarction (STEMI) or non-ST-segment elevation AMI (NSTEMI).
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardio Med Medical Center | Târgu Mureş | 540124 | Romania |
Not provided
Not provided
Not provided
Not provided
Collection of venous blood samples at baseline and at 7 days after AMI for assessment of complete blood count, biochemistry, serum levels of hs-CRP, MMPs, IL6, NT-pro-BNP.
| Laboratory analysis | Diagnostic Test |
|
|
| Day 7 |
| ID | Term |
|---|---|
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D020257 | Ventricular Remodeling |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D020763 | Pathological Conditions, Anatomical |
Not provided
Not provided