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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Central Hospital, Nancy, France
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01109225
First received: April 22, 2010
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

to determine if the aldosteronemy proves to be predictive of a cardiac remodeling in the 6 months following a STEMI (myocardial infarction with know-shift of the segment ST) revascularized in acute phase, independently of the conventional predictive parameters (size of the infarction measured in IRM, age, HTA…).

the relation between aldosteronemy and cardiovascular events could be mainly explained by the early and long-term noxious effects of the aldosterone on cardiac remodeling


Condition Intervention
Myocardial Infarction
Procedure: aldosteronemy determination

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:
  • Aldosterone blood concentration in myocardial infraction [ Time Frame: June, 2014 ] [ Designated as safety issue: No ]
    Determine whether aldosterone blood concentration can predict cardiac remodelling 6 months after myocardial infraction with ST segment elevation independently of conventional parameters


Secondary Outcome Measures:
  • Determine if the potential deleterious action of aldosterone on cardiac remodelling is dependant on specific clinical settings [ Time Frame: June, 2014 ] [ Designated as safety issue: No ]
    Analysis of vascular function. Analysis of cardiac function, structure and strain by MRI and echocardiography.


Estimated Enrollment: 250
Study Start Date: April 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aldosterone Procedure: aldosteronemy determination
to take a sample of blood

Detailed Description:

After myocardial infarction, the evolution towards cardiac failure is generally related to a progressive aggravation of the cardiac dysfunction, noxious remodeling. This one depends above all on wide on the after-effects on infarction, but also on other parameters such as the age and arterial hypertension. The aldosteronemy measured as of the first hours of the infarction is associated with a bad long-term forecast. The aldosterone interacts at the same time on the mechanisms of cicatrisation and cicatricial fibrosis and on the conditions of load (volemy, vascular function). Medications anti-aldosterone can antagonise these noxious effects but they are not without adverse effects and one cannot identify the patients likely yet to really profit from it: arterial hypertension could be a prerequisite (study EPHESUS), like the attack of a critical threshold of size of the infarction (principal remodeling factor)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Man or woman hospitalized for an firstly-infarction myocardic with known shift of the segment ST revascularized in acute phase by primary angioplasty and going back to 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 IRM
  • 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

Contacts
Contact: Nicolas GIRERD, Doctor +33 03 83 15 7322 n.girerd@chu-nancy.fr

Locations
France
Nancy Brabois university hospital Recruiting
Vandoeuvre les Nancy, Meurthe et Moselle, France, 54500
Contact: Nicolas GIRERD, doctor    +33 3 83 15 73 22    n.girerd@chu-nancy.fr   
Contact: Pierre Yves MARIE       py.marie@chu-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
  More Information

No publications provided

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: January 31, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Central Hospital, Nancy, France:
aldosterone

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 October 16, 2014