NCT00679575

Brief Summary

The main objective of this case-referent study is to assess the impact of statins usage on the risk of having a first myocardial infarction (MI) in a real life situation in France

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13,171

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2007

Typical duration for all trials

Geographic Reach
1 country

56 active sites

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

March 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

December 8, 2010

Status Verified

December 1, 2010

Enrollment Period

3.7 years

First QC Date

May 15, 2008

Last Update Submit

December 6, 2010

Conditions

Keywords

statinsmyocardial infarctioncase-referent studyFrance

Outcome Measures

Primary Outcomes (1)

  • Assess the impact of the different statins (molecules) usage on the risk of having a first myocardial infarction in a real life situation in France

    in 2011

Secondary Outcomes (3)

  • Assess the interaction between statin treatment and risk factors such as cholesterol, age, gender, tobacco, alcohol, co-prescriptions, co-morbidities

    in 2011

  • Assess the populational impact of statins usage on the risk of having a first myocardial infarction

    in 2011

  • Assess the risk of having a first myocardial infarction according to high and low dosages of statins

    in 2011

Study Arms (2)

1

Cases : Patients with a first myocardial infarction

2

Referents : Patients recruited by a GP during a routine consultation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cases : Patients recruited by a cardiologist in hospital / Referents : Patients recruited by a GP, community sample

You may qualify if:

  • Patients can speak French or English
  • Patients can be interviewed by telephone
  • Place of usual residence in the area of recruitment

You may not qualify if:

  • Patients refusing to participate in the study
  • Patients who cannot be reached by telephone
  • Previous history of myocardial infarction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (56)

Research Site

Ambilly, France

Location

Research Site

Angers, France

Location

Research Site

Arles, France

Location

Research Site

Bagnols-sur-Cèze, France

Location

Research Site

Bayonne, France

Location

Research Site

Béziers, France

Location

Research Site

Boulogne-sur-Mer, France

Location

Research Site

Bourgoin, France

Location

Research Site

Bron, France

Location

Research Site

Cambo-les-Bains, France

Location

Research Site

Cenon, France

Location

Research Site

Châteauroux, France

Location

Research Site

Clermont-Ferrand, France

Location

Research Site

Colmar, France

Location

Research Site

Crest, France

Location

Research Site

Dijon, France

Location

Research Site

Draguignan, France

Location

Research Site

Eaubonne, France

Location

Research Site

Firminy, France

Location

Research Site

Forbach, France

Location

Research Site

Fréjus, France

Location

Research Site

Gleizé, France

Location

Research Site

Grasse, France

Location

Research Site

Guéret, France

Location

Research Site

La Rochelle, France

Location

Research Site

Langres, France

Location

Research Site

Laon, France

Location

Research Site

Le Coudray, France

Location

Research Site

Le Mans, France

Location

Research Site

Le Puy-en-Velay, France

Location

Research Site

Mayenne, France

Location

Research Site

Millau, France

Location

Research Site

Montélimar, France

Location

Research Site

Montfermeil, France

Location

Research Site

Montpellier, France

Location

Research Site

Nîmes, France

Location

Research Site

Orange, France

Location

Research Site

Orléans, France

Location

Research Site

Paris, France

Location

Research Site

Pau, France

Location

Research Site

Perpignan, France

Location

Research Site

Puilboreau, France

Location

Research Site

Rueil-Malmaison, France

Location

Research Site

Rumilly, France

Location

Research Site

Saint Amand Monrond, France

Location

Research Site

Saint Jean Des Verges, France

Location

Research Site

Saint-Estève, France

Location

Research Site

Sallanches, France

Location

Research Site

Salon-de-Provence, France

Location

Research Site

Sens, France

Location

Research Site

Thonon-les-Bains, France

Location

Research Site

Toulouse, France

Location

Research Site

Tours, France

Location

Research Site

Tulles, France

Location

Research Site

Valence, France

Location

Research Site

Villefranche-de-Rouergue, France

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Lucien Abenhaim

    LA-SER29, rue du Faubourg Saint-Jacques75014 Paris

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 15, 2008

First Posted

May 19, 2008

Study Start

March 1, 2007

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

December 8, 2010

Record last verified: 2010-12

Locations