Status: FinalisedLast updated on: 19/03/2019
1. Study identification
EU PAS Register NumberEUPAS10726
Official titleObservational study of post-myocardial infarction with a long follow-up
Study title acronymEOLE
Study typeObservational study
Brief description of the studyThe EOLE study was requested by French authorities at the time of new omega-3 supplementation marketing for secondary prevention of post-myocardial infarction. The main research question is to assess the impact of recommended cardiovascular drugs (beta-blockers, acetylsalicylic acid or other antiplatelet agents, statins or other lipid lowering agent, angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, and omega-3 supplementation), and dietary lifestyle guidelines in real-life to all cause mortality in secondary prevention of myocardial infarction in France after 6 years of follow-up. Hospital and non-hospital cardiologists included 5527 patients from April 2006 to June 2009. Socio-demographic data, myocardial infarction characteristics, cardiovascular risk factors, history and associated cardiovascular diseases, last lab test results, cardiovascular drugs, cardiovascular rehabilitation program, tobacco use, drugs taken, hospitalisations since myocardial infarction and vital status were collected using a medical questionnaire completed at first post-myocardial infarction consultation, and a patient self-administered questionnaire filled out at inclusion, 6 month, 2, 3, 4, 5 and 6 years. At 6 years follow-up, the vital status of all patients will be ascertained from the national death registry using a standard approved national procedure whereby the national identification database is searched (decree #98-37 of 16 January 1998, modified procedure INSEE/INSERM), and failing that, through patient/relatives/physicians. An interim analysis will be planned after 3.5 years of follow-up
Was this study requested by a regulator?Yes: France
Is the study required by a Risk Management Plan (RMP)? Not applicable
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBordeaux PharmacoEpi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.pharmacoepi.eu
Details of (Primary) lead investigator
Title Professor
Last name Moore
First name Nicholas
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed21/12/2005
Start date of data collection01/03/2006
Start date of data analysis05/01/2009
Date of interim report, if expected03/02/2013
Date of final study report30/06/201612/07/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesPierre Fabre MĂ©dicament100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Blin
First name Patrick
Address line 1146 Rue Leo Saignat
Address line 2 
Address line 3 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name Blin 
First name Patrick 
Address line 1146 Rue Leo Saignat 
Address line 2 
Address line 3 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code) 
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