Relation Between Aldosterone and Cardiac Remodeling After Myocardial Infarction

Not Applicable

Completed

• Conditions: Myocardial Infarction
• Interventions: Biological: blood sample; Procedure: MRI; Procedure: echocardiography; Biological: urine sample; Procedure: pulmonary echography; Procedure: vascular check; Procedure: renal echography

• Registration Number: NCT01109225
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2010-04-22
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-23
• Study Start: 2010-04-27
• Primary Completion: 2014-03
• Study Completion: 2020-02-04
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-22
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Myocardial infarction	urine sample	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
Myocardial infarction	MRI	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
Myocardial infarction	echocardiography	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
Myocardial infarction	blood sample	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
Myocardial infarction	pulmonary echography	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
Myocardial infarction	vascular check	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
Myocardial infarction	renal echography	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Long-term cardiac remodeling measured by echocardiography at 3 to 9 years of initial enrollment	at 3 to 9 years of initial enrollment

Trial Locations

Locations (1)

Nancy Brabois university hospital; 🇫🇷 Vandoeuvre les Nancy, Meurthe Et Moselle, France