NCT01109225

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2010

Completed
4 days until next milestone

Study Start

First participant enrolled

April 27, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2020

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

3.8 years

First QC Date

April 22, 2010

Last Update Submit

March 22, 2021

Conditions

Myocardial Infarction

Keywords

aldosteronemyocardial infarctioncardiac remodeling

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

Myocardial infarction

EXPERIMENTAL

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 sampleProcedure: MRIProcedure: echocardiographyBiological: urine sampleProcedure: pulmonary echographyProcedure: vascular checkProcedure: renal echography

Interventions

blood sampleBIOLOGICAL
Myocardial infarction
MRIPROCEDURE
Myocardial infarction
echocardiographyPROCEDURE
Myocardial infarction
urine sampleBIOLOGICAL
Myocardial infarction
pulmonary echographyPROCEDURE
Myocardial infarction
vascular checkPROCEDURE
Myocardial infarction
renal echographyPROCEDURE
Myocardial infarction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nancy Brabois university hospital

Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54500, France

Location

Related Publications (6)

  • Monzo L, Huttin O, Ferreira JP, Lamiral Z, Bozec E, Beaumont M, Micard E, Baudry G, Marie PY, Eschalier R, Rossignol P, Zannad F, Girerd N. Role of aldosterone in mid- and long-term left ventricular remodelling after acute myocardial infarction: The REMI study. Eur J Heart Fail. 2023 Oct;25(10):1742-1752. doi: 10.1002/ejhf.2986. Epub 2023 Aug 24.

    PMID: 37530453DERIVED

  • Huttin O, Mandry D, Eschalier R, Zhang L, Micard E, Odille F, Beaumont M, Fay R, Felblinger J, Camenzind E, Zannad F, Girerd N, Marie PY. Cardiac remodeling following reperfused acute myocardial infarction is linked to the concomitant evolution of vascular function as assessed by cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2017 Jan 4;19(1):2. doi: 10.1186/s12968-016-0314-6.

    PMID: 28063459DERIVED

  • Huttin O, Marie PY, Benichou M, Bozec E, Lemoine S, Mandry D, Juilliere Y, Sadoul N, Micard E, Duarte K, Beaumont M, Rossignol P, Girerd N, Selton-Suty C. Temporal deformation pattern in acute and late phases of ST-elevation myocardial infarction: incremental value of longitudinal post-systolic strain to assess myocardial viability. Clin Res Cardiol. 2016 Oct;105(10):815-26. doi: 10.1007/s00392-016-0989-6. Epub 2016 Apr 23.

    PMID: 27108156DERIVED

  • Huttin O, Petit MA, Bozec E, Eschalier R, Juilliere Y, Moulin F, Lemoine S, Selton-Suty C, Sadoul N, Mandry D, Beaumont M, Felblinger J, Girerd N, Marie PY. Assessment of Left Ventricular Ejection Fraction Calculation on Long-axis Views From Cardiac Magnetic Resonance Imaging in Patients With Acute Myocardial Infarction. Medicine (Baltimore). 2015 Oct;94(43):e1856. doi: 10.1097/MD.0000000000001856.

    PMID: 26512596DERIVED

  • Lemarie J, Huttin O, Girerd N, Mandry D, Juilliere Y, Moulin F, Lemoine S, Beaumont M, Marie PY, Selton-Suty C. Usefulness of Speckle-Tracking Imaging for Right Ventricular Assessment after Acute Myocardial Infarction: A Magnetic Resonance Imaging/Echocardiographic Comparison within the Relation between Aldosterone and Cardiac Remodeling after Myocardial Infarction Study. J Am Soc Echocardiogr. 2015 Jul;28(7):818-27.e4. doi: 10.1016/j.echo.2015.02.019. Epub 2015 Mar 31.

    PMID: 25840640DERIVED

  • Huttin O, Lemarie J, Di Meglio M, Girerd N, Mandry D, Moulin F, Lemoine S, Juilliere Y, Felblinger J, Marie PY, Selton-Suty C. Assessment of right ventricular functional recovery after acute myocardial infarction by 2D speckle-tracking echocardiography. Int J Cardiovasc Imaging. 2015 Mar;31(3):537-45. doi: 10.1007/s10554-014-0585-7. Epub 2015 Jan 6.

    PMID: 25559651DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Nicolas GIRERD, Doctor

    Centre d'Investigation Clinique Plurithématique 1433/INSERM/CHRU de Nancy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2010

First Posted

April 23, 2010

Study Start

April 27, 2010

Primary Completion

March 1, 2014

Study Completion

February 4, 2020

Last Updated

March 24, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)