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Relation Between Aldosterone and Cardiac Remodeling After Myocardial Infarction (REMI)

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
MRI
echocardiography
urine sample
pulmonary echography
vascular check
renal echography
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Infarction focused on measuring aldosterone, myocardial infarction, cardiac remodeling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nancy Brabois university hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Myocardial infarction

Arm Description

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: blood sample MRI echocardiography urine sample pulmonary echography vascular check renal echography

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Vascular and cardiac parameters measured during the initial assesment and at 6 months (both functional and structural - by echocardiography or MRI)
Long-term cardiac remodeling measured by echocardiography at 3 to 9 years of initial enrollment

Full Information

First Posted
April 22, 2010
Last Updated
March 22, 2021
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT01109225
Brief Title
Relation Between Aldosterone and Cardiac Remodeling After Myocardial Infarction
Acronym
REMI
Official Title
Multiparametric Study of Cardiac Remodeling After Myocardial Infarction Revascularized in Acute Phase : Relation With the Serum Concentrations in Aldosterone
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 27, 2010 (Actual)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
February 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
aldosterone, myocardial infarction, cardiac remodeling

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Myocardial infarction
Arm Type
Experimental
Arm Description
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: blood sample MRI echocardiography urine sample pulmonary echography vascular check renal echography
Intervention Type
Biological
Intervention Name(s)
blood sample
Intervention Type
Procedure
Intervention Name(s)
MRI
Intervention Type
Procedure
Intervention Name(s)
echocardiography
Intervention Type
Biological
Intervention Name(s)
urine sample
Intervention Type
Procedure
Intervention Name(s)
pulmonary echography
Intervention Type
Procedure
Intervention Name(s)
vascular check
Intervention Type
Procedure
Intervention Name(s)
renal echography
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas GIRERD, Doctor
Organizational Affiliation
Centre d'Investigation Clinique Plurithématique 1433/INSERM/CHRU de Nancy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nancy Brabois university hospital
City
Vandoeuvre les Nancy
State/Province
Meurthe Et Moselle
ZIP/Postal Code
54500
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28063459
Citation
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.
Results Reference
derived
PubMed Identifier
27108156
Citation
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.
Results Reference
derived
PubMed Identifier
26512596
Citation
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.
Results Reference
derived
PubMed Identifier
25840640
Citation
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.
Results Reference
derived
PubMed Identifier
25559651
Citation
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.
Results Reference
derived

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Relation Between Aldosterone and Cardiac Remodeling After Myocardial Infarction

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