Relation Between Aldosterone and Cardiac Remodeling After Myocardial Infarction

Myocardial Infarction Clinical Trial

— REMI  

Official title:

Multiparametric Study of Cardiac Remodeling After Myocardial Infarction Revascularized in Acute Phase : Relation With the Serum Concentrations in Aldosterone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109225
• Other study ID #: 2009-A00537-50
• Status: Completed
• Phase: N/A
• Start date: April 27, 2010
• Est. completion date: February 4, 2020

Study information

• Verified date: March 2021
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: February 4, 2020
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Biological:
• blood sample

Procedure:
• MRI

• echocardiography

Biological:
• urine sample

Procedure:
• pulmonary echography

• vascular check

• renal echography

Locations

Country	Name	City	State
France	Nancy Brabois university hospital	Vandoeuvre les Nancy	Meurthe Et Moselle

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		from initial assessment to 6 months
Secondary	Vascular and cardiac parameters measured during the initial assesment and at 6 months (both functional and structural - by echocardiography or MRI)		from initial assessment to 6 months
Secondary	Long-term cardiac remodeling measured by echocardiography at 3 to 9 years of initial enrollment		at 3 to 9 years of initial enrollment