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| Sponsor: | Hospices Civils de Lyon |
|---|---|
| Information provided by: | Hospices Civils de Lyon |
| ClinicalTrials.gov Identifier: | NCT00859300 |
Purpose
We propose a comparative case-control study on the 2 following groups of patients:
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 36 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: | Case Control, Prospective |
| Official Title: | MAP-IDM: Identification of Molecular Markers of Sudden Death at the Acute Phase of Myocardial Infarction. A Case Control Study |
| Estimated Enrollment: | 800 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
400 patients with ventricular fibrillation at the acute phase of myocardial infarct
|
Genetic: Blood sample
Blood sample Determination of genetic background
|
|
2
400 patients without ventricular fibrillation at the acute phase of myocardial infarct.
|
Genetic: Blood sample
Blood sample Determination of genetic background
|
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 |
Cases: 400 patients with ventricular fibrillation at the acute phase of myocardial infarct, Controls: 400 patients without ventricular fibrillation at the acute phase of myocardial infarct.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: CHEVALIER Philippe, MD | 33 4 72 68 49 46 | philippe.chevalier@chu-lyon.fr |
| France | |
| Hôpital cardiologique | Recruiting |
| Lyon, France, 69677 | |
| Contact: CHEVALIER Philippe, MD 33 4 72 68 49 46 philippe.chevalier@chu-lyon.fr | |
| Principal Investigator: | CHEVALIER Philippe, MD | Hospices Civils de Lyon |
More Information
| Responsible Party: | Hospices Civils de Lyon ( Pr CHEVALIER ) |
| Study ID Numbers: | 2007.463 |
| Study First Received: | March 5, 2008 |
| Last Updated: | March 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00859300 History of Changes |
| Health Authority: | France: Direction Générale de la Santé |
|
myocardial infarction ventricular fibrillation sudden death polymorphism |
|
Necrosis Death Heart Diseases Pathologic Processes Myocardial Ischemia Death, Sudden |
Vascular Diseases Cardiovascular Diseases Ischemia Infarction Myocardial Infarction |
