FASTMI2015: French Registry of Acute ST-elevation or Non-ST-elevation Myocardial Infarction 2015

Sponsor
French Cardiology Society (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02566200
Collaborator
Assistance Publique - Hôpitaux de Paris (Other)
5,000
1
144
34.7

Study Details

Study Description

Brief Summary

Over the last two decades, considerable progress has been made in the management of myocardial infarction, both in the acute phase and in monitoring beyond the hospital phase. However changing practices in the "real world" and their impact on prognosis in the medium and long term patients admitted to the intensive care unit for acute myocardial infarction are relatively little studied exhaustively.

The study of clinical, biological and genetic characteristics of patients and their conditions of care, help to identify patients at risk for increased morbidity and mortality after myocardial infarction and could be the basis for the subsequent realization of specific studies on the optimal therapeutic management of the disease according to the different risk profiles.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a multicenter observational study, given to 300 prospective medical facilities, including a clinic or intensive care unit entitled to receive emergency acute coronary syndromes.

    Patients will be recruited consecutively during a period of 2 months.

    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.

    The ambition of the 2015 Observatory of the French Society of Cardiology is through a photograph "scale" of the practices in France at present, to ensure consistency in the quality of care for hospitalized patients heart attack; the investigation will emphasize the strengths but also the weaknesses of our health care system so that should improve. Finally, the observation of a large population of the real world will give the opportunity to assess the interactions between the different types of treatments used and check their possible synergy or incompatibilities.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    5000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    French Registry of Acute ST-elevation or Non-ST-elevation Myocardial Infarction 2015
    Actual Study Start Date :
    Oct 1, 2015
    Actual Primary Completion Date :
    May 1, 2017
    Anticipated Study Completion Date :
    Oct 1, 2027

    Arms and Interventions

    Arm Intervention/Treatment
    IM group

    Patients admitted in intensive care for a myocardial infarction

    Outcome Measures

    Primary Outcome Measures

    1. All cause mortality 1 year after hospitalization for a myocardial infarction [1 year after hospitalization]

    Secondary Outcome Measures

    1. All cause mortality 10 years after hospitalization for a myocardial infarction [10 years after hospitalization]

    2. To determine the impact of genetic, serology, fecal biomarkers on the myocardial infarction and its complications. [10 years after hospitalization]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Male or female aged over 18 years

    2. Patients admitted within 48 hours of onset of symptoms in a coronary intensive care unit (USIC) for acute myocardial infarction (MI) defined by:

    A rise and fall of typical troponin (or CPKMb) associated with at least one of the following:

    • symptoms consistent with myocardial ischemia

    • development of pathological Q waves

    • repolarisation disorders related to ischemia (or in addition to ST depression, T wave inversion)

    1. And having agreed to participate in the study.
    Exclusion Criteria:
    1. Refusal to consent

    2. MI occurring in the 48 hours after therapeutic intervention (bypass surgery or coronary angioplasty or other surgical procedure)

    3. Diagnosis of myocardial reversed in favor of an alternative diagnosis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HEGP Paris France

    Sponsors and Collaborators

    • French Cardiology Society
    • Assistance Publique - Hôpitaux de Paris

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    French Cardiology Society
    ClinicalTrials.gov Identifier:
    NCT02566200
    Other Study ID Numbers:
    • 15597
    First Posted:
    Oct 2, 2015
    Last Update Posted:
    Aug 14, 2019
    Last Verified:
    Aug 1, 2019
    Keywords provided by French Cardiology Society
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 14, 2019