Cardiac arrest registry of the Greater Paris area
| ISRCTN | ISRCTN36541230 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36541230 |
- Submission date
- 05/01/2017
- Registration date
- 16/01/2017
- Last edited
- 15/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Sudden cardiac arrest is a condition where the heart suddenly and unexpectedly stops beating, which usually causes death if not treated within minutes (sudden cardiac death). In spite of advances in treatment, it remains a frequent and often fatal disease, with highly different survival rates between studies and countries. The aim of this study is to create a registry (database) of patients who have an out-of-hospital cardiac arrest in Paris or its suburbs (Hauts-de-Seine, Seine-Saint-Denis, Val-de-Marne).
Who can participate?
Patients aged over 18 who have an out-of-hospital cardiac arrest in Paris or its suburbs (Hauts-de-Seine, Seine-Saint-Denis, Val-de-Marne) and are treated by the Emergency Medical Service (EMS)
What does the study involve?
Patient data is collected, including their demographic characteristics and the location of their arrest. Information is also collected about the care patients receive before admission to hospital, such as response time (the delay between call and arrival of EMS), presence of bystander, bystander cardio-pulmonary resuscitation (CPR) before EMS arrival, presence of shockable heart rhythm, attempted defibrillation during resuscitation, dose of epinephrine delivered by EMS, and survival until admission. For every hospitalized patient, the hospitalization report is recorded, including past medical history, tests, coronary angiogram, and death or discharge from hospital.
What are the possible benefits and risks of participating?
As the study only involves collecting data there are no benefits or risks of participating.
Where is the study run from?
Hospitals in Paris and its suburbs (Hauts-de-Seine, Seine-Saint-Denis, Val-de-Marne)
When is the study starting and how long is it expected to run for?
May 2011 to May 2041
Who is funding the study?
1. Institut National de la Santé et de la Recherche Médicale (France)
2. Université Paris Descartes (France)
3. Fédération Française de Cardiologie (France)
4. Société Française de Cardiologie (France)
5. Fondation Coeur et Artères (France)
6. Global Heart Watch (France)
7. Fondation pour la Recherche Médicale (France)
Who is the main contact?
1. Prof. Xavier Jouven
2. Dr Wulfran Bougouin
Contact information
Scientific
INSERM U970, Team 4
56 rue Leblanc
Paris
75015
France
Scientific
INSERM U970, Team 4
56 rue Leblanc
Paris
75015
France
Study information
| Study design | Prospective population-based observational registry |
|---|---|
| Primary study design | Observational |
| Secondary study design | Epidemiological study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Out-of-hospital cardiac arrest registry of the Paris Sudden Death Expertise Centre, France |
| Study acronym | SDEC registry |
| Study objectives | In spite of therapeutic advances, sudden cardiac death (SCD) remains a frequent and often fatal disease, with highly different survival rates between studies and countries. Knowledge about the extent of this disease is crucial in order to match research themes with public health needs. In a recent meta-analysis, Sasson et al. reported a survival rate to hospital discharge after SCD between 6 and 8%. However, the French emergency medical system (EMS) differs significantly from the North American EMS, with early medicalization of patients. The impact of this marked specificity is discussed. To the best of our knowledge, prognosis of SCD is not documented in the French EMS system. During OHCA patients' hospitalization, percutaneous coronary intervention (PCI) and therapeutic hypothermia (TH) have been proposed to improve the prognosis of SCD. However, despite their inclusion in guidelines, the extent of these therapies in clinical practice is not known, and available data are derived from trials involving intensive care units highly aware of the benefits of these therapies, or from declarative surveys. Considering the lack of broad epidemiological data, a population-based registry has been developed with multiple sources, serving exhaustively a large population in Paris and its suburbs, representing more than 10% of the overall French population. |
| Ethics approval(s) | 1. CCTIRS (Comité Consultatif sur le Traitement de l'Information en matière de Recherche dans le domaine de la Santé), 07/06/2012, ref: 12-336 2. CNIL (Commission Nationale de l'Informatique et des Libertés), 18/09/2012, ref: 912309 |
| Health condition(s) or problem(s) studied | Out-of-hospital sudden cardiac death |
| Intervention | The Sudden Death Expertise Center (SDEC) Registry is a population-based registry, concerning Paris and its suburbs (Hauts-de-Seine, Seine-Saint-Denis, Val-de-Marne), including a residential population of approximately 6.6 million and covering 762 km2 (294 square miles). According to definitions from recent guidelines, every case of out-of-hospital Sudden Cardiac Death (SCD), defined as unexpected death without obvious extra-cardiac cause, occurring in the area of interest, with age over 18 years, was included in SDEC registry, from the 15/05/2011, for at least 20 years. Exclusion criteria were patients aged under 18 years old, SCD occurring outside the area of interest, prior terminal condition (such as metastatic malignancy), or obvious non-cardiac cause according to Utstein templates (trauma, submersion, respiratory, etc). To ensure completeness of collection, the SDEC Registry was derived from an intensive and prospective epidemiologic case-finding. Combining passive and active attitudes warranted the most extensive collection of cases of SCD, significantly superior to passive detection of cases alone. In addition, an individual review of each case ensured specificity, and avoided the overestimation often experienced in retrospective collection. Utstein templates for patient data collection were followed. General data included demographic characteristics and location of arrest (street address, residential or public place). Data recorded about pre-hospital care included response time (defined by the delay between call and arrival of EMS), presence of bystander, bystander cardio-pulmonary resuscitation (CPR) before EMS arrival, presence of shockable rhythm before advanced life support, defibrillation attempt during resuscitation, deliverance and dose of epinephrine (total dose delivered by EMS during Advance Life Support), and survival until admission. For every hospitalized patient, the hospitalization report was recorded, including past medical history, biological tests, therapeutic hypothermia, coronary angiogram, death or discharge from hospital, and neurological status at discharge (according to Cerebral Performance Category [CPC] score, considering a CPC score of 1 or 2 as a favorable outcome). Two investigators reviewed each record for data completion and validity. |
| Intervention type | Other |
| Primary outcome measure | Survival at hospital discharge, assessed using hospitalization reports |
| Secondary outcome measures | 1. Survival at ICU discharge 2. 7 days survival 3. 30 days survival 4. Neurological status at discharge, according to Cerebral Performance Category (CPC) score, considering a CPC score of 1 or 2 as a favorable outcome 5. One-year survival 6. Long-term survival 7. Cause-of-death analysis |
| Overall study start date | 16/05/2011 |
| Completion date | 15/05/2041 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 3000 per year |
| Key inclusion criteria | 1. Out-of-hospital SCD (defined as unexpected death without obvious extra-cardiac cause) occurring in Paris or its suburbs (Hauts-de-Seine, Seine-Saint-Denis, Val-de-Marne) 3. Age over 18 years 4. Treated by the Emergency Medical Service |
| Key exclusion criteria | 1. Patients aged under 18 years old 2. Cardiac arrest occurring outside the area of interest 3. Prior terminal condition (such as metastatic malignancy) 4. Obvious non-cardiac cause according to Utstein templates (trauma, submersion, respiratory, etc) |
| Date of first enrolment | 16/05/2011 |
| Date of final enrolment | 15/05/2041 |
Locations
Countries of recruitment
- France
Study participating centres
France
75015
France
92140
France
92380
France
75018
France
75010
France
94270
France
France
75015
France
75015
France
France
75014
France
75014
France
92151
France
93100
France
75013
France
93000
France
France
93200
France
93100
France
75475
France
94010
France
France
92700
France
75014
France
94010
France
92100
France
75014
France
75020
France
93370
France
75013
France
75012
France
75475
France
75010
France
75015
France
75013
France
France
France
75015
France
94010
France
94270
France
93200
France
75012
France
93600
France
75018
France
92100
France
93370
France
75013
France
Sponsor information
University/education
56 Rue Leblanc
Paris
75015
France
"ROR" |
https://ror.org/02vjkv261 |
|---|
Funders
Funder type
University/education
Government organisation / Research institutes and centers
- Alternative name(s)
- French National Institute for Health and Medical Research, French National Institute of Health & Medical Research, National Institute of Health and Medical Research, Inserm
- Location
- France
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Paris Descartes University, Universität Paris Descartes, Universidad Paris Descartes
- Location
- France
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- French Federation of Cardiology, fedecardio, FFC
- Location
- France
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- French Society of Cardiology, SFC
- Location
- France
No information available
No information available
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Foundation for Medical Research, FRM
- Location
- France
Results and Publications
| Intention to publish date | 01/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2011 | Yes | No | |
| Results article | results | 01/06/2014 | Yes | No | |
| Results article | results | 07/11/2016 | Yes | No | |
| Results article | results | 06/12/2016 | Yes | No | |
| Results article | results | 20/12/2016 | Yes | No | |
| Results article | results | 01/01/2017 | Yes | No |
Editorial Notes
15/01/2025: The following changes were made:
1. The overall study end date was changed from 15/05/2031 to 15/05/2041.
2. The recruitment end date was changed from 15/05/2031 to 15/05/2041.
3. The intention to publish date was changed from 31/12/2017 to 01/01/2026.
28/08/2019: Internal review.
