French Registry of Acute Coronary Syndrome With or Without ST Elevation 2010 (FAST-MI 2010)
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Purpose
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 |
|---|
|
Myocardial Infarction Acute Coronary Syndrome |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | French Registry of Acute Coronary Syndrome With or Without ST Elevation 2010 |
- Survival [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]Compare survival in the hospital after admission in Intensive Care Unit in the manner of care
- Survival in long-term [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
When normal blood test done at the patient's admission into ISB, an additional quantity of 60 ml of blood will be drawn up for building a DNAthèque (15 ml) and a serum bank (45 ml) on only markers related to atherosclerotic disease
| Estimated Enrollment: | 3700 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | December 2022 |
| Estimated Primary Completion Date: | December 2021 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
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 More Information
Publications:
| Responsible Party: | Nicolas DANCHIN, Professor, French Cardiology Society |
| ClinicalTrials.gov Identifier: | NCT01237418 History of Changes |
| Other Study ID Numbers: | 10240 |
| Study First Received: | November 8, 2010 |
| Last Updated: | June 13, 2012 |
| Health Authority: | France: CNIL France: CCTIRS |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Acute Coronary Syndrome Ischemia Pathologic Processes Necrosis Myocardial Ischemia |
Heart Diseases Cardiovascular Diseases Vascular Diseases Angina Pectoris Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013