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Trial record 20 of 222 for:    Aldosterone

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

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ClinicalTrials.gov Identifier: NCT01109225
Recruitment Status : Active, not recruiting
First Posted : April 23, 2010
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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 Phase
Myocardial Infarction Biological: blood sample Procedure: MRI Procedure: echocardiography Biological: urine sample Procedure: pulmonary echography Procedure: vascular check Procedure: renal echography Not Applicable

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.

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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
Actual Primary Completion Date : March 2014
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Aldosterone

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



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 9 years of initial enrollment [ Time Frame: at 3 to 9 years of initial enrollment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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

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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: June 25, 2019
Last Verified: June 2019
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:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases