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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01109225
First received: April 22, 2010
Last updated: May 12, 2017
Last verified: May 2017
  Purpose
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 Intervention
Myocardial Infarction Biological: blood sample Procedure: MRI Procedure: echocardiography Biological: urine sample Procedure: pulmonary echography Procedure: vascular check Procedure: renal echography

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 145
Actual Study Start Date: April 2010
Estimated Study Completion Date: April 2019
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 22, 2010
Last Updated: May 12, 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

ClinicalTrials.gov processed this record on September 21, 2017