Participating centres

A list of all intensive cardiac care units authorized to receive acute coronary syndrome emergencies and admitting patients at the acute stage of myocardial infarction was established at the beginning of 2015. Participation in the study was offered to all types of institutions (academic hospitals, general hospitals, army hospitals and private clinics). In all, 261 centres were listed, 215 of which initially accepted to participate. Of those, 204 actively participated and included at least one patient during the 1-month study period. The participation rate was 78% and the centres were distributed across the whole country ( Fig. 1 ). In addition, other centres could receive AMI patients at their emergency departments, but immediately referred these patients to other institutions. These centres were not asked to participate in the registry as the patients were included at the “receiving” institutions.

Geographic distribution of the centres participating in FAST-MI 2015.

The participating centres comprised 114 general hospitals, 40 academic hospitals, 38 private clinics, 10 private not-for-profit clinics and 2 army hospitals.

Recruitment

Patients were recruited consecutively from intensive cardiac care units/cardiology departments over a period of 1 month (from 5 October 2015). Recruitment could be prolonged up to 2 months in centres willing to do so. A physician was responsible for study recruitment at each centre. The population included during the first month by the totality of participating centres is used as illustrative of current management and outcomes in France, while the whole population (i.e. that recruited during the first and the second month) will be used to address specific medical interrogations in a larger population. The results presented here are those of the first month.

Organization of the study for the participants

A list of all patients admitted within 48 hours of symptom onset for a suspicion of acute coronary syndrome was established at each institution and the entry criteria were checked. A computerized case record form was completed for each eligible patient, based on the hospital records and additional specific questionnaires. Data were recorded by dedicated research technicians from a contract research organization (Axonal, Nanterre, France) who went to each centre on a weekly basis. In the case of incomplete data from the source patient files, the research technicians contacted the local investigator to obtain missing information.

Data collection

Demographic data as well as social characteristics (type of work, health coverage, mode of living) were recorded. Cardiovascular and non-cardiovascular medical history (cardiovascular, lung, renal, neurological or cognitive disease, cancer), risk factors (smoking status, hypertension, hypercholesterolaemia, family history of coronary disease, diabetes mellitus), and clinical course over hospital stay, including symptoms, admission and highest Killip class, therapeutic management in the prehospital setting, during the first 48 hours, during the hospital stay and at discharge, were recorded. Left ventricular ejection fraction (LVEF), when assessed at entry and at any time during the hospital stay, was recorded. Casual laboratory results were collected on admission. All in-hospital complications were recorded. The variables collected comprised those collected in the previous FAST-MI surveys along with several additional variables of interest.

In 152 centres, a biological substudy collected blood and serum samples for the assessment of DNA, RNA or centralized measurement of biological markers; some centres also collected stools for studying intestinal microbiota. Blood samples were collected within 24 hours of admission and samples were centralized with the help of the research organization (CEMO, Choisy-le-Roi, France).

Data quality

Data quality was ensured using numerous automated checks when the electronic case record forms were completed and by the fact that all the data entered were verified, and modified if necessary, by external research assistants. This methodology was also used for the FAST-MI 2005 and 2010 surveys. An external audit was also carried out on 10% of the records, to ensure adequate data quality.

Completeness of the data was adequate for most variables (e.g. missing values < 4% for height and 3% for weight; 3% for admission blood pressure and heart rate; < 0.5% for risk factors or cardiovascular history). After a dedicated external audit led by the principal investigator (ND), medications used at the acute stage (first 48 h) were retrieved in all but 7 (0.1%) patients; for these 7 patients, medications used during the first 48 hours were extrapolated from the treatment protocols used in the centres and from the medications used in the prehospital setting and at discharge.

Once entered into the electronic case record form, data were stored in a central database at the French Society of Cardiology in Paris. Data management is ensured, in conjunction with the French Society of Cardiology and the cardiology departments of Toulouse, hôpital européen Georges-Pompidou and Besançon university hospitals.

Patient follow-up

Follow-up data are collected by dedicated research technicians based at the French Society of Cardiology under the supervision of the unité de recherche clinique (URC-EST) of Assistance publique–Hôpitaux de Paris (AP–HP), using the following sequential procedure, which was also used for the FAST-MI 2005 and 2010 registries:

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  consulting the registry offices of the patients’ birthplaces for death certificates;

  
  
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  contacting the patients’ general practitioners and/or cardiologists;

  
  
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  contacting the patients or their relatives direct.

In many instances, written contact was followed by telephone interviews to the patients or their families.

For each reported event leading to hospitalization or death, hospital discharge reports were sought and analysed by at least one physician. All these events were reviewed centrally by a physician from a three-member critical events committee. Cases in which the final diagnosis appeared unclear or debatable were reviewed by at least two members of the critical events committee. Information on the occurrence of acute coronary syndromes, myocardial revascularization, hospitalization for heart failure, stroke, bleeding events requiring hospitalization or hospitalization for cancer were specifically tracked. The database was cross-linked with the French Institute for National Statistics and the French national cause-of-death database (CepiDC), to gather additional information on the causes of death, when appropriate. Finally, to evaluate changes in practice in France over the past 15 years, individual data from the 1995, 2000, 2005, 2010 and 2015 registries were merged into a common database.

Conduct of the registry, legal issues and funding

Written informed consent was provided by each patient. The data from patients who died early (i.e. before informed consent was obtained) were collected and recorded in the database, unless opposed to by the patient’s next of kin.

The study was conducted in compliance with Good Clinical Practice, French law and the French data protection law. The protocol was reviewed and approved by the Committee for the Protection of Human Subjects (CPP) of Saint-Louis University Hospital Paris Île-de-France IV. The data recorded and the way they were handled and stored was reviewed and approved by the comité consultatif sur le traitement de l’information en matière de recherche dans le domaine de la santé (CCTIRS) and the Commission nationale informatique et liberté (CNIL). The study is registered (Clinicaltrials.gov identifier: NCT02566200 ).

The study is funded by unrestricted grants from the following companies: AstraZeneca, Amgen, Bayer, BMS-Pfizer, Boehringer-Ingelheim, the Daiichi-Sankyo-Eli-Lilly alliance, MSD and Sanofi. Complementary grants will be sought for dedicated research projects within the main study.