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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01109225
First Posted: April 23, 2010
Last Update Posted: May 16, 2017
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.
Information provided by (Responsible Party):
Central Hospital, Nancy, France
April 22, 2010
April 23, 2010
May 16, 2017
April 2010
March 2014   (Final data collection date for primary outcome measure)
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 ]
aldosterone blood concentration [ Time Frame: April, 2012 ]
Complete list of historical versions of study NCT01109225 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
cardiac MRI [ Time Frame: april 2012 ]
Not Provided
Not Provided
 
Relation Between Aldosterone and Cardiac Remodeling After Myocardial Infarction
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.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Myocardial Infarction
  • Biological: blood sample
  • Procedure: MRI
  • Procedure: echocardiography
  • Biological: urine sample
  • Procedure: pulmonary echography
  • Procedure: vascular check
  • Procedure: renal echography
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
Interventions:
  • Biological: blood sample
  • Procedure: MRI
  • Procedure: echocardiography
  • Biological: urine sample
  • Procedure: pulmonary echography
  • Procedure: vascular check
  • Procedure: renal echography

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
145
April 2019
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01109225
2009-A00537-50
No
Not Provided
Plan to Share IPD: No
Central Hospital, Nancy, France
Central Hospital, Nancy, France
Not Provided
Principal Investigator: Nicolas GIRERD, Doctor Centre d'Investigation Clinique Plurithématique 1433/INSERM/CHRU de Nancy
Central Hospital, Nancy, France
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP