Condition category
Circulatory System
Date applied
05/01/2017
Date assigned
16/01/2017
Last edited
13/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 2031

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Xavier Jouven

ORCID ID

Contact details

INSERM U970
Team 4
56 rue Leblanc
Paris
75015
France

Type

Scientific

Additional contact

Dr Wulfran Bougouin

ORCID ID

Contact details

INSERM U970
Team 4
56 rue Leblanc
Paris
75015
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

-

Study information

Scientific title

Out-of-hospital cardiac arrest registry of the Paris Sudden Death Expertise Centre, France

Acronym

SDEC registry

Study hypothesis

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

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

Study design

Prospective population-based observational registry

Primary study design

Observational

Secondary study design

Epidemiological study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

16/05/2011

Overall trial end date

15/05/2031

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

3000 per year

Participant 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)

Recruitment start date

16/05/2011

Recruitment end date

15/05/2031

Locations

Countries of recruitment

France

Trial participating centre

SAMU 93
93000
France

Trial participating centre

Georges Pompidou European Hospital
Medical ICU
75015
France

Trial participating centre

Béclère Hospital
Cardiology Department
92140
France

Trial participating centre

Raymond Poincare Hospital
Medical ICU
92380
France

Trial participating centre

Bichat Hospital
Cardiology Department
75018
France

Trial participating centre

Saint Louis Hospital
Medical ICU
75010
France

Trial participating centre

Bicêtre Hospital
Surgical ICU
94270
France

Trial participating centre

PARCC, INSERM U970
75015
France

Trial participating centre

Georges Pompidou European Hospital
Cardiology Department
75015
France

Trial participating centre

Necker Hospital
Medical ICU
75015
France

Trial participating centre

SAMU 75
75015
France

Trial participating centre

Saint Joseph Hospital
Medical ICU
75014
France

Trial participating centre

Cochin Hospital
Medical ICU
75014
France

Trial participating centre

Foch Hospital
Medical ICU
92151
France

Trial participating centre

Montreuil Hospital
Cardiology Department
93100
France

Trial participating centre

Pitié Salpétrière Hospital
Medical ICU
75013
France

Trial participating centre

Avicenne Hospital
Medical-Surgical Intensive Care Unit
93000
France

Trial participating centre

SAMU 92
92380
France

Trial participating centre

Delafontaine Hospital
ICU
93200
France

Trial participating centre

Montreuil Hospital
ICU
93100
France

Trial participating centre

Lariboisière Hospital
Medical ICU
75475
France

Trial participating centre

Mondor Hospital
Surgical ICU
94010
France

Trial participating centre

Paris Fire Brigade
75000
France

Trial participating centre

Louis Mourier Hospital
Medical ICU
92700
France

Trial participating centre

Cochin Hospital
Cardiology Department
75014
France

Trial participating centre

Mondor Hospital
Cardiology Department
94010
France

Trial participating centre

Ambroise Paré Hospital
Cardiology Department
92100
France

Trial participating centre

Cochin Hospital
Emergency Department
75014
France

Trial participating centre

Tenon Hospital
Medical ICU
75020
France

Trial participating centre

Montfermeil Hospital
ICU
93370
France

Trial participating centre

Pitié Salpétrière Hospital
Cardiology Department
75013
France

Trial participating centre

Saint Antoine Hospital
Medical ICU
75012
France

Trial participating centre

Lariboisière Hospital
Cardiology Department
75475
France

Trial participating centre

Saint Louis Hospital
Surgical ICU
75010
France

Trial participating centre

Georges Pompidou European Hospital
Surgical ICU
75015
France

Trial participating centre

Pitié Salpétrière Hospital
Surgical ICU
75013
France

Trial participating centre

SAMU 94
94010
France

Trial participating centre

Institute of Legal Medicine
75012
France

Trial participating centre

Necker Hospital
Department of Pediatric Cardiology
75015
France

Trial participating centre

Mondor Hospital
Medical ICU
94010
France

Trial participating centre

Bicêtre Hospital
Medical ICU
94270
France

Trial participating centre

Centre cardiologique du Nord
Cardiology Department
93200
France

Trial participating centre

Pitié Salpétrière Hospital
Neuropathology Department
75012
France

Trial participating centre

Robert Ballanger Hospital
ICU
93600
France

Trial participating centre

Bichat Hospital
Medical ICU
75018
France

Trial participating centre

Ambroise Paré Hospital
Medical ICU
92100
France

Trial participating centre

Montfermeil Hospital
Cardiology Department
93370
France

Trial participating centre

Pitié Salpétrière Hospital
Medical Intensive Care Unit and Respiratory Division
75013
France

Sponsor information

Organisation

INSERM U970, Team 4

Sponsor details

56 Rue Leblanc
Paris
75015
France

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Institut National de la Santé et de la Recherche Médicale

Alternative name(s)

National Institute of Health and Medical Research, Inserm

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

France

Funder name

Université Paris Descartes

Alternative name(s)

Paris Descartes University, Universität Paris Descartes, Universidad Paris Descartes

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

France

Funder name

Fédération Française de Cardiologie

Alternative name(s)

French Federation of Cardiology, FFC

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

France

Funder name

Société Française de Cardiologie

Alternative name(s)

French Society of Cardiology, SFC

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

France

Funder name

Fondation Coeur et Artères

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Global Heart Watch

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fondation pour la Recherche Médicale

Alternative name(s)

Foundation for Medical Research in France, FRM

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

France

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing plans
The current data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

31/12/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/22117906
2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24658912
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27994026
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27618681
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26497161
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/27865776

Publication citations

Additional files

Editorial Notes