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

April 22, 2010
January 31, 2014
April 2010
June 2014   (final data collection date for primary outcome measure)
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
aldosterone blood concentration [ Time Frame: April, 2012 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01109225 on ClinicalTrials.gov Archive Site
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.
cardiac MRI [ Time Frame: april 2012 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Relation Between Aldosterone and Cardiac Remodeling After Myocardial Infarction
Multiparametric Study of Cardiac Remodeling After Myocardial Infarction Revascularized in Acute Phase : Relation With the Serum Concentrations in Aldosterone

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

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)

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Myocardial Infarction
Procedure: aldosteronemy determination
to take a sample of blood
Experimental: aldosterone
Intervention: Procedure: aldosteronemy determination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Nicolas GIRERD, Doctor +33 03 83 15 7322 n.girerd@chu-nancy.fr
France
 
NCT01109225
2009-A00537-50
No
Central Hospital, Nancy, France
Central Hospital, Nancy, France
Not Provided
Not Provided
Central Hospital, Nancy, France
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP