Clinical trial NCT01237418: French Registry of Acute Coronary Syndrome With or Without ST Elevation 2010
Official title: French Registry of Acute Coronary Syndrome With or Without ST Elevation 2010
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Acute Coronary Syndrome
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 4168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival
timeFrame: 1 month
Secondary outcomes:
measure: Survival in long-term
timeFrame: 10 years
Other outcomes:
Locations:
city: Paris
country: France
facility: European Hospital Georges Pompidou
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Nicolas Danchin
role: PRINCIPAL_INVESTIGATOR
References:
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