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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nicolas DANCHIN, French Cardiology Society
ClinicalTrials.gov Identifier:
NCT01237418
First received: November 8, 2010
Last updated: September 27, 2013
Last verified: September 2013
  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

Resource links provided by NLM:


Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01237418

Locations
France
European Hospital Georges Pompidou
Paris, France
Sponsors and Collaborators
French Cardiology Society
Investigators
Principal Investigator: Nicoals Danchin AP-HP
  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: September 27, 2013
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 April 23, 2014