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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01109225
Recruitment Status : Active, not recruiting
First Posted : April 23, 2010
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Myocardial Infarction Biological: blood sample Procedure: MRI Procedure: echocardiography Biological: urine sample Procedure: pulmonary echography Procedure: vascular check Procedure: renal echography

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multiparametric Study of Cardiac Remodeling After Myocardial Infarction Revascularized in Acute Phase : Relation With the Serum Concentrations in Aldosterone
Actual Study Start Date : April 2010
Primary Completion Date : March 2014
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Aldosterone
U.S. FDA Resources

Arms and Interventions

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:

  • blood sample
  • MRI
  • echocardiography
  • urine sample
  • pulmonary echography
  • vascular check
  • renal echography
Biological: blood sample Procedure: MRI Procedure: echocardiography Biological: urine sample Procedure: pulmonary echography Procedure: vascular check Procedure: renal echography


Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. Long-term cardiac remodeling measured by echocardiography at 3 to 7 years of initial enrollment [ Time Frame: at 3 to 7 years of initial enrollment ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109225


Locations
France
Nancy Brabois university hospital
Vandoeuvre les Nancy, Meurthe et Moselle, France, 54500
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Nicolas GIRERD, Doctor Centre d'Investigation Clinique Plurithématique 1433/INSERM/CHRU de Nancy
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01109225     History of Changes
Other Study ID Numbers: 2009-A00537-50
First Posted: April 23, 2010    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Central Hospital, Nancy, France:
aldosterone
myocardial infarction
cardiac remodeling

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases