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

September 20, 2022 updated by: Nicolas DANCHIN, French Cardiology Society

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

3700

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

  • France
      • Paris, France
        • European Hospital Georges Pompidou

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

Patients will be recruited consecutively in the CIAU member during a period of 2 months, including sub-populations of specific interest (diabetes and / or elderly patients, for example). A list of eligible patients not included and must be completed by the participating centers during the same period, with reasons for non inclusion.

A questionnaire will be sent to each center prior to recruitment, including type of service and number of beds in the facility.

The study will be given to any medical facility, University Hospital, CHG, CHR, health facility of the Army, including a clinic or intensive care unit entitled to receive emergency ACS. In each center, a medical consultant will be appointed to collect phenotypic data for the study case report forms in electronic patient.

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 1 month
Compare survival in the hospital after admission in Intensive Care Unit in the manner of care
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival in long-term
Time Frame: 10 years
10 years

Collaborators and Investigators

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

Sponsor

French Cardiology Society

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

October 1, 2010

Primary Completion (Actual)

December 31, 2021

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

November 8, 2010

First Submitted That Met QC Criteria

November 8, 2010

First Posted (Estimate)

November 9, 2010

Study Record Updates

Last Update Posted (Actual)

September 22, 2022

Last Update Submitted That Met QC Criteria

September 20, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10240 (Other Identifier: CTEP)

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.

Clinical Trials on Myocardial Infarction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe