MAP-IDM: Identification of Molecular Markers of Sudden Death at the Acute Phase of Myocardial Infarction (MAP-IDM)

March 15, 2016 updated by: Hospices Civils de Lyon

MAP-IDM: Identification of Molecular Markers of Sudden Death at the Acute Phase of Myocardial Infarction. A Case Control Study

We propose a comparative case-control study on the 2 following groups of patients:

  • Cases: 500 patients with ventricular fibrillation at the acute phase of myocardial infarct,
  • Controls: 500 patients without ventricular fibrillation at the acute phase of myocardial infarct.

The primary endpoint in this study is the correlation phenotype/genotype of sudden death at the acute phase of myocardial infarct.

The first phase of the study, including patients' recruitment, clinical and biological data collection, will last 82 months. The second phase will concern the genotype/phenotype analysis and the identification of polymorphisms associated with a sudden death risk after a myocardial infarction.

This study will allow a better knowledge of the mechanisms of sudden death and the identification of new risk markers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The number of sudden death is estimated around 50000 in France. In most cases, these deaths are due to myocardial infarction. This complication occurs, for 70% of cases, at the patient's residence, within 30 minutes following the thoracic pain. Emergency care often comes too late and allows only 2% of the patients having a heart failure to be revitalized.

At equal sex, age and clinical status, patients may or not develop ventricular rhythm disorders. Then, the notions of risk background and genetic disposition should be investigated.

No prospective study has been conducted on a sufficient number of patients yet. Such a study and the recent development of new genetic technologies will help identifying markers of sudden death risk at the acute phase of myocardial infarction.

The study we are implementing will increase knowledge on sudden death mechanisms at the acute phase of myocardial infarction. The analysis of phenotypic/genotypic relations will lead to an identification of new risk markers. Further evaluations of new diagnostic and therapeutic strategies will be possible on the basis of this trial.

Ventricular fibrillation at the acute phase of myocardial infarction follows a polygenic determinism. The genes involved in this electrical trouble are those which lead to the expression of potassic, calcic and sodic channels of ventricular myocytes: KCNQ1, KCNH2, SCN5A, KCNE1, KCNE2, KCNJ2, PRKAG2, RyR2, PKP2, DSP, CASQ2, CACNA1C, and FKBP1B.

An association of a favourable genetic background and ischemia represents a cause for ventricular arrhythmia as a complication of myocardial infarction.

Haplotypes or genes considered as new markers for sudden death risk of ischemic origin will be searched.

Study Type

Observational

Enrollment (Actual)

1011

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69677
        • Hopital Cardiologique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cases: 500 patients with ventricular fibrillation at the acute phase of myocardial infarct, Controls: 500 patients without ventricular fibrillation at the acute phase of myocardial infarct.

Description

Inclusion Criteria:

  • All patients admitted to ICU for MI and presenting the following criteria:
  • Age > 18
  • Group 1 (Case) Patients with cardiac arrest and ventricular fibrillation developed up to 24 h post MI Group 2 (control) Patients with MI (no ventricular fibrillation)
  • Written informed consent.

Exclusion Criteria:

  • No written informed consent
  • Known Medical History of cardiomyopathy, including acute coronary syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
500 patients with ventricular fibrillation at the acute phase of myocardial infarct
Genetic: Blood sample
Blood sample Determination of genetic background
2
500 patients without ventricular fibrillation at the acute phase of myocardial infarct.
Genetic: Blood sample
Blood sample Determination of genetic background

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation phenotype/genotype of sudden death at the acute phase of myocardial infarct.
Time Frame: Correlation phenotype/genotype
Correlation phenotype/genotype

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: CHEVALIER Philippe, MD, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

March 5, 2008

First Submitted That Met QC Criteria

March 10, 2009

First Posted (Estimate)

March 11, 2009

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007.463

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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