French Registry of Acute Coronary Syndrome - Full Text View

French Registry of Acute Coronary Syndrome (Fast-MI)

This study is currently recruiting participants.

Verified by Assistance Publique - Hôpitaux de Paris, February 2009

First Received: May 5, 2008 Last Updated: February 11, 2009 History of Changes

Sponsor:	Assistance Publique - Hôpitaux de Paris
Collaborator:	French Cardiology Society
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00673036

Purpose

The Fast-MI registry was designed to evaluate the "real world" management of patients with acute myocardial infarction (MI), and to assess their in-hospital, medium and long-term outcomes

Condition	Intervention
Acute Myocardial Infarction	Other: Blood sample

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	French Registry of Acute Coronary Syndrome With or Without ST Elevation

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

All causes mortality at each follow-up period [ Time Frame: 6 months, each year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Cardiovascular mortality [ Time Frame: 6 month, each year ] [ Designated as safety issue: Yes ]
validation of guidelines accross the country [ Time Frame: 6 month, each year ] [ Designated as safety issue: No ]
Pharmacogenetic and cardiovascular genetic studies associated to clinical outcomes [ Time Frame: 6 month each year ] [ Designated as safety issue: No ]
Serum databank for evaluation of biomarkers in MI [ Time Frame: 6 month each year ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Whole blood, serum and DNA

Estimated Enrollment:	3750
Study Start Date:	October 2005
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 Adults (female and male) with a acute coronary syndrome	Other: Blood sample 60 ml of whole blood

Detailed Description:

Primary objectives : compare survival following the admission to a USIC according to the terms of care

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

Admitted patients in a Unit of Coronary Intensive Care (USIC) for a acute coronary syndrome

Criteria

Inclusion Criteria:

admission within the 48 hours after the occurence of acute myocardial infarction (AMI)
written informed consent for the DNA and serum databank

Exclusion Criteria:

AMI occured within the 48 hours after therapeutic intervention (bypass, coronary angioplasty or other chirurgical intervention)
diagnostic of AMI not confirmed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673036

Contacts

Contact: Tabassome SIMON, MD	33 - 1 49 28 22 02	urcest@chusa.jussieu.fr
Contact: Nicolas Danchin, MD PhD	33 - 1 44 90 70 35

Locations

France
French Society of Cardiology	Recruiting
Paris, France, 75012
Contact: Tabassome Simon, MD 33 1 49 28 22 02 urcest@chusa.jussieu.fr
Contact: Nicolas Danchin, MD PhD 33 1 44 90 70 35

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

French Cardiology Society

Investigators

Principal Investigator:

Nicolas DANCHIN, MD PH

Assistance Publique - Hôpitaux de Paris

Responsible Party:	French Society of Cardiology ( Dr Tabassome Simon and Pr Nicolas Danchin )
Study ID Numbers:	04-1244
Study First Received:	May 5, 2008
Last Updated:	February 11, 2009
ClinicalTrials.gov Identifier:	NCT00673036 History of Changes
Health Authority:	France: French Data Protection Authority