Relation Between Aldosterone and Cardiac Remodeling After Myocardial Infarction (REMI)
March 22, 2021 updated by: Central Hospital, Nancy, France
Multiparametric Study of Cardiac Remodeling After Myocardial Infarction Revascularized in Acute Phase : Relation With the Serum Concentrations in Aldosterone
This study aims to determine whether aldosterone blood levels are predictive of cardiac remodeling at 6 months following myocardial infarction with ST elevation (STEMI), independently of conventional predictive factors (size of myocardial infarction, age, hypertension, etc.) in revascularized patients during the acute phase of MI.
Study Overview
Status
Completed
Conditions
Detailed Description
After myocardial infarction, the evolution toward cardiac failure is generally linked to a progressive worsening of cardiac dysfunction and remodeling.
Cardiac remodeling is largely the consequence of myocardial injury due to myocardial infarction, although other parameters including age, arterial hypertension, etc. may also represent important predictors.
Aldosterone blood levels measured within the first hours of admission for myocardial infarction is associated with increased rates of adverse outcomes.
Aldosterone acts on wound healing and fibrosis processes in the myocardium as well as on systemic volemia.
Study Type
Interventional
Enrollment (Actual)
145
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Meurthe Et Moselle
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Vandoeuvre les Nancy, Meurthe Et Moselle, France, 54500
- Nancy Brabois university hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Man or woman hospitalized for a first myocardial infarction with known shift of the segment ST revascularized in acute phase by primary angioplasty and dated less than 4 days
- Patient presenting a stable clinical state
- Patient presenting a regular sinusal cardiac rhythm
- Patient having an age ≥ 18 years
Exclusion Criteria:
- Counter-indication with examination MRI
- Severe claustrophobia
- Antecedent of over-sensitiveness to gadolinium salts
- Nonischaemic Cardiopathy
- Cardiac surgery planed in the 6 months
- Women into old to procreate without effective contraception
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Myocardial infarction
All patients. Patients hospitalized for a first myocardial infarction with known shift of the segment ST revascularized in acute phase by primary angioplasty and dated less than 4 days. Intervention:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cardiac remodeling within 6 months of myocardial infarction as defined as the change in left ventricle volumes (increase of more than 20 % of the diastolic volume of the left ventricle)
Time Frame: from initial assessment to 6 months
|
from initial assessment to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Vascular and cardiac parameters measured during the initial assesment and at 6 months (both functional and structural - by echocardiography or MRI)
Time Frame: from initial assessment to 6 months
|
from initial assessment to 6 months
|
|
Long-term cardiac remodeling measured by echocardiography at 3 to 9 years of initial enrollment
Time Frame: at 3 to 9 years of initial enrollment
|
at 3 to 9 years of initial enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nicolas GIRERD, Doctor, Centre d'Investigation Clinique Plurithématique 1433/INSERM/CHRU de Nancy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Huttin O, Mandry D, Eschalier R, Zhang L, Micard E, Odille F, Beaumont M, Fay R, Felblinger J, Camenzind E, Zannad F, Girerd N, Marie PY. Cardiac remodeling following reperfused acute myocardial infarction is linked to the concomitant evolution of vascular function as assessed by cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2017 Jan 4;19(1):2. doi: 10.1186/s12968-016-0314-6.
- Huttin O, Marie PY, Benichou M, Bozec E, Lemoine S, Mandry D, Juilliere Y, Sadoul N, Micard E, Duarte K, Beaumont M, Rossignol P, Girerd N, Selton-Suty C. Temporal deformation pattern in acute and late phases of ST-elevation myocardial infarction: incremental value of longitudinal post-systolic strain to assess myocardial viability. Clin Res Cardiol. 2016 Oct;105(10):815-26. doi: 10.1007/s00392-016-0989-6. Epub 2016 Apr 23.
- Huttin O, Petit MA, Bozec E, Eschalier R, Juilliere Y, Moulin F, Lemoine S, Selton-Suty C, Sadoul N, Mandry D, Beaumont M, Felblinger J, Girerd N, Marie PY. Assessment of Left Ventricular Ejection Fraction Calculation on Long-axis Views From Cardiac Magnetic Resonance Imaging in Patients With Acute Myocardial Infarction. Medicine (Baltimore). 2015 Oct;94(43):e1856. doi: 10.1097/MD.0000000000001856.
- Lemarie J, Huttin O, Girerd N, Mandry D, Juilliere Y, Moulin F, Lemoine S, Beaumont M, Marie PY, Selton-Suty C. Usefulness of Speckle-Tracking Imaging for Right Ventricular Assessment after Acute Myocardial Infarction: A Magnetic Resonance Imaging/Echocardiographic Comparison within the Relation between Aldosterone and Cardiac Remodeling after Myocardial Infarction Study. J Am Soc Echocardiogr. 2015 Jul;28(7):818-27.e4. doi: 10.1016/j.echo.2015.02.019. Epub 2015 Mar 31.
- Huttin O, Lemarie J, Di Meglio M, Girerd N, Mandry D, Moulin F, Lemoine S, Juilliere Y, Felblinger J, Marie PY, Selton-Suty C. Assessment of right ventricular functional recovery after acute myocardial infarction by 2D speckle-tracking echocardiography. Int J Cardiovasc Imaging. 2015 Mar;31(3):537-45. doi: 10.1007/s10554-014-0585-7. Epub 2015 Jan 6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 27, 2010
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
February 4, 2020
Study Registration Dates
First Submitted
April 22, 2010
First Submitted That Met QC Criteria
April 22, 2010
First Posted (Estimate)
April 23, 2010
Study Record Updates
Last Update Posted (Actual)
March 24, 2021
Last Update Submitted That Met QC Criteria
March 22, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-A00537-50
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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