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Myocardial InfarctionREMINCT01109225

Relation Between Aldosterone and Cardiac Remodeling After Myocardial Infarction

A study testing blood sample, MRI and echocardiography in people with Myocardial Infarction, run by Central Hospital, Nancy, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Infarction
What is being tested?
blood sample, MRI and echocardiography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
145 participants
Where
1 siteFrance
Study dates
27 Apr 2010to 4 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Nancy Brabois university hospital

    Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54500

Other trials in France

About this study

Official title: Multiparametric Study of Cardiac Remodeling After Myocardial Infarction Revascularized in Acute Phase : Relation With the Serum Concentrations in Aldosterone

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.

Read the 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.

Being tested
blood sample, MRI, echocardiography, urine sample, pulmonary echography
Keywords
aldosterone, myocardial infarction, cardiac remodeling
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood sampleBiological

  • MRIProcedure or surgery

  • echocardiographyProcedure or surgery

  • urine sampleBiological

  • pulmonary echographyProcedure or surgery

  • vascular checkProcedure or surgery

  • renal echographyProcedure or surgery

Study groups in NCT01109225
Study groupRoleWhat they receive
Myocardial infarctionExperimentalAll 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
Receives: Biological: blood sample; Procedure: MRI; Procedure: echocardiography; Biological: urine sample; Procedure: pulmonary echography; Procedure: vascular check; Procedure: renal echography

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: from initial assessment to 6 months

Secondary outcomes (2)

  1. Vascular and cardiac parameters measured during the initial assesment and at 6 months (both functional and structural - by echocardiography or MRI)

    Measured: from initial assessment to 6 months

  2. Long-term cardiac remodeling measured by echocardiography at 3 to 9 years of initial enrollment

    Measured: at 3 to 9 years of initial enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2010 (estimated)
  2. Study start27 Apr 2010
  3. Primary completionMar 2014
  4. Study completion4 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01109225
Sponsor's protocol ID
2009-A00537-50
Acronym
REMI
Status last verified
Mar 2021
First submitted
22 Apr 2010
Last updated
24 Mar 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37530453

  • 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.

    PubMed 28063459

  • 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.

    PubMed 27108156

  • 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.

    PubMed 26512596

  • 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.

    PubMed 25840640

  • 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.

    PubMed 25559651

Questions about this trial

What is this clinical trial studying?

A study testing blood sample, MRI and echocardiography in people with Myocardial Infarction, run by Central Hospital, Nancy, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01109225, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.

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