FAST-MI 2010: French Registry of Acute Coronary Syndrome With or Without ST Elevation 2010

Sponsor
French Cardiology Society (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01237418
Collaborator
(none)
3,700
1
146
25.3

Study Details

Study Description

Brief Summary

The observatory FAST MI 2010 proposes to establish a cohort of 3500 patients recruited prospectively over a period of 2 months.

Patients will be followed up at 1 month and then followed annually for 10 years.

Patients should have agreed to participate in the study, participation in the protocol, or refusal to participate will not affect the therapeutic approach of the physician. The study of genotypic or phenotypic characteristics will not change the therapeutic approach of health care teams.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a multicenter observational study, given to 300 prospective medical facilities, CHU, CHG, CHR, health facility of the Army, including a clinic or intensive care unit entitled to receive emergency ACS. (See attached list 10-6) A questionnaire will be sent to each center before the recruitment center on the type and number of beds (Appendix 10-5)

    Patients will be recruited consecutively in the CIAU member during a period of 2 months.

    The 1-month follow-up will be done by the referring physician of each ISB, by mail or telephone contact with the treating physician and / or patient.

    Annual follow-ups will be conducted during 10 years of clinical research technicians of the French Society of Cardiology, mail and / or telephone contact with the municipalities of birth, treating physicians and patients.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3700 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    French Registry of Acute Coronary Syndrome With or Without ST Elevation 2010
    Study Start Date :
    Oct 1, 2010
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Dec 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Myocardial Infarction

    Any patient over 18 years admitted for myocardial infarction (MI) of less than 48 hours, characterized by the typical rise and fall of troponin or CPKMb

    Outcome Measures

    Primary Outcome Measures

    1. Survival [1 month]

      Compare survival in the hospital after admission in Intensive Care Unit in the manner of care

    Secondary Outcome Measures

    1. Survival in long-term [10 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria :
    • Patients over 18 years old

    • Admitted patient for a myocardial infarction (MI) of less than 48 hours, characterized by the typical rise and fall of troponin or CPKMb associated with at least one of the following: symptoms of myocardial ischemia or appearance of pathological Q waves or repolarization disorders related to ischemia (in addition to or NSTEMI)

    • Patient who consented to participate in the study

    Exclusion Criteria:
    • Refusal of consent

    • MI occurring within 48 h after a therapeutic intervention (angioplasty or coronary bypass or other surgery)

    • Diagnosis of SCA reversed in favor of an alternative diagnosis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 European Hospital Georges Pompidou Paris France

    Sponsors and Collaborators

    • French Cardiology Society

    Investigators

    • Principal Investigator: Nicolas Danchin, Assistance Publique - Hôpitaux de Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Nicolas DANCHIN, Professor, French Cardiology Society
    ClinicalTrials.gov Identifier:
    NCT01237418
    Other Study ID Numbers:
    • 10240
    First Posted:
    Nov 9, 2010
    Last Update Posted:
    Aug 15, 2019
    Last Verified:
    Aug 1, 2019

    Study Results

    No Results Posted as of Aug 15, 2019