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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00859300
First received: March 5, 2008
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Myocardial Infarction
Genetic: Blood sample

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: MAP-IDM: Identification of Molecular Markers of Sudden Death at the Acute Phase of Myocardial Infarction. A Case Control Study

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Correlation phenotype/genotype of sudden death at the acute phase of myocardial infarct. [ Time Frame: Correlation phenotype/genotype ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: December 2007
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

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

Criteria

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
  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: NCT00859300

Contacts
Contact: CHEVALIER Philippe, MD 33 4 72 68 49 46 philippe.chevalier@chu-lyon.fr

Locations
France
Hôpital cardiologique Recruiting
Lyon, France, 69677
Contact: CHEVALIER Philippe, MD    33 4 72 68 49 46    philippe.chevalier@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: CHEVALIER Philippe, MD Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00859300     History of Changes
Other Study ID Numbers: 2007.463
Study First Received: March 5, 2008
Last Updated: February 4, 2014
Health Authority: France: ANSM

Keywords provided by Hospices Civils de Lyon:
myocardial infarction
ventricular fibrillation
sudden death
polymorphism

Additional relevant MeSH terms:
Death, Sudden
Infarction
Myocardial Infarction
Cardiovascular Diseases
Death
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014