French Registry of Acute Coronary Syndrome (Fast-MI)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
French Cardiology Society
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00673036
First received: May 5, 2008
Last updated: August 6, 2013
Last verified: August 2013
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: French Registry of Acute Coronary Syndrome With or Without ST Elevation

Resource links provided by NLM:


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 across 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

Whole blood, serum and DNA


Estimated Enrollment: 3750
Study Start Date: October 2005
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (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
Other Name: Blood sample

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

Locations
France
French Society of Cardiology
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
French Cardiology Society
Investigators
Principal Investigator: Nicolas DANCHIN, MD PH Assistance Publique - Hôpitaux de Paris
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00673036     History of Changes
Other Study ID Numbers: 04-1244
Study First Received: May 5, 2008
Last Updated: August 6, 2013
Health Authority: France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Coronary syndrome
Myocardial infarction
French registry

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014