NCT00859300

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,011

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

Longer than P75 for all trials

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

Study Start

First participant enrolled

December 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2008

Completed
1 year until next milestone

First Posted

Study publicly available on registry

March 11, 2009

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

7.5 years

First QC Date

March 5, 2008

Last Update Submit

March 15, 2016

Conditions

Keywords

myocardial infarctionventricular fibrillationsudden deathpolymorphism

Outcome Measures

Primary Outcomes (1)

  • Correlation phenotype/genotype of sudden death at the acute phase of myocardial infarct.

    Correlation phenotype/genotype

Study Arms (2)

1

500 patients with ventricular fibrillation at the acute phase of myocardial infarct

Genetic: Blood sample

2

500 patients without ventricular fibrillation at the acute phase of myocardial infarct.

Genetic: Blood sample

Interventions

Blood sample Determination of genetic background

1

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital cardiologique

Lyon, 69677, France

Location

Related Publications (2)

  • Chevalier P, Roy P, Bessiere F, Morel E, Ankou B, Morgan G, Halder I, London B, Minobe WA, Slavov D, Deliniere A, Bochaton T, Paganelli F, Lesavre N, Boiteux C, Mansourati J, Maury P, Clerici G, Winum PF, Huebler SP, Carroll IA, Bristow MR. Impact of Neuroeffector Adrenergic Receptor Polymorphisms on Incident Ventricular Fibrillation During Acute Myocardial Ischemia. J Am Heart Assoc. 2023 Mar 21;12(6):e025368. doi: 10.1161/JAHA.122.025368. Epub 2023 Mar 16.

  • Chevalier P, Moreau A, Bessiere F, Richard S, Chahine M, Millat G, Morel E, Paganelli F, Lesavre N, Placide L, Montestruc F, Ankou B, Puertas RD, Asatryan B, Deliniere A; MAP-IDM Investigators. Identification of Cx43 variants predisposing to ventricular fibrillation in the acute phase of ST-elevation myocardial infarction. Europace. 2023 Feb 8;25(1):101-111. doi: 10.1093/europace/euac128.

MeSH Terms

Conditions

Myocardial InfarctionVentricular FibrillationDeath, Sudden

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisArrhythmias, CardiacDeath

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • CHEVALIER Philippe, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2008

First Posted

March 11, 2009

Study Start

December 1, 2007

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations