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

September 20, 2022 updated by: French Cardiology Society

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient hospitalized in an intensive care unit in France for an acute myocardial infarction

Description

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)
  3. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
IM group
Patients admitted in intensive care for a myocardial infarction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality 1 year after hospitalization for a myocardial infarction
Time Frame: 1 year after hospitalization
1 year after hospitalization

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause mortality 10 years after hospitalization for a myocardial infarction
Time Frame: 10 years after hospitalization
10 years after hospitalization
To determine the impact of genetic, serology, fecal biomarkers on the myocardial infarction and its complications.
Time Frame: 10 years after hospitalization
10 years after hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Cardiology Society

Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Anticipated)

October 1, 2027

Study Registration Dates

First Submitted

September 30, 2015

First Submitted That Met QC Criteria

September 30, 2015

First Posted (Estimate)

October 2, 2015

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 20, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15597

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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