Condition category
Circulatory System
Date applied
08/12/2016
Date assigned
08/12/2016
Last edited
08/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Sudden cardiac arrest (SCA) is a serious medical condition in which the heart suddenly stops beating. It is commonly caused by cardiac arrhythmia (heart rhythm disorder) and is the most common cause of death in the developed world. These heart rhythm disorders are caused by complex interactions between various factors such as inherited factors, lifestyle factors and environmental factors. A SCA is lethal within minutes if left unteated, in particular, rapid defibrillation (a shock to the chest to get the heart pumping again) and resuscitation are crucial to increase chances of survival. This, along with prevention strategies are the best ways for prventing death from SCA. The difficulty with these strategies lies in the fact that SCA generally occurs unexpectedly and out-of-hospital. Because of this, it is usually very difficult to obtain clear information about all the factors that have caused the SCA in that particular person. The ARREST registry is designed to resolve these difficulties by improving understanding of the causes of SCA in the community and by evaluating the most effective treatments of SCA. To achieve this aim, the ARREST registry includes all out-of-hospital SCA cases in a particular region of the Netherlands, collecting information of the factors that may underlie SCA occurrence, along with detailed data on the ways in which resuscitation was performed. The aim of this study is to evaluate the ARREST registry and its use in understanding the causes of SCA and the best treatments.

Who can participate?
All individuals in the ARREST region (North-Holland province of the Netherlands) who suffer out-of-hospital SCA.

What does the study involve?
Information about sudden cardiac arrest (SCA) patients is collected from the emergency medical services, hospital, general practitioner, public pharmacy, and public registries; DNA is collected from residual material taken for the sake of patient care (e.g., blood samples). Patients are enrolled in this study when they suffer SCA. They cannot provide informed consent prior to enrolment, because occurrence of SCA is presently unpredictable. Informed consent can also not be obtained during SCA, because SCA is a medical emergency, in which the patients are unconscious. Therefore, informed consent can only be obtained afterwards. Survivors of SCA are therefore contacted after they have recovered sufficiently to have regained their ability to make an informed decision to provide written consent to participate in this study. If they decide not to participate, the patient is withdrawn from the study and DNA samples will be destroyed.

What are the possible benefits and risks of participating?
A possible benefit is that this study improves the ability to prevent SCA (SCA victims are at increased risk of suffering SCA again), and to develop more effective treatments for out-of-hospital SCA. There are no risks involved with participating.

Where is the study run from
Department of Cardiology, Heart Center, Academic Medical Center (Netherlands)

When is study starting and how long is it expected to run for?
June 2005 to December 2031

Who is funding the study?
1. European Commission: Horizon 2020 (Belgium)
2. Netherlands CardioVascular Research Initiative (Netherlands)
3. Netherlands Organization for Scientific Research (Netherlands)
4. Dutch Medicines Evaluation Board (Netherlands)
5. Dutch Heart Foundation (Netherlands)
6. Zoll Medical (Netherlands)
7. Cardiac Science (USA)
8. ZonMW (Netherlands)
9. Laerdal Foundation (Netherlands)

Who is the main contact?
1. Dr Hanno Tan (scientific)
2. Dr Marieke Blom (scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hanno Tan

ORCID ID

http://orcid.org/0000-0002-7905-5818

Contact details

Academisch Medisch Centrum
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Type

Scientific

Additional contact

Dr Marieke Blom

ORCID ID

http://orcid.org/0000-0002-8088-1105

Contact details

Academisch Medisch Centrum
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

ARREST registry: AmsteRdam REsuscitation STudies

Acronym

ARREST

Study hypothesis

1. Sudden cardiac arrest may be prevented by understanding the interactions between the underlying causative factors
2. Sudden cardiac arrest may be better treated by designing more effective out-of-hospital treatment strategies

Ethics approval

1. Medical Ethics Committee Academic Medical Center Amsterdam, 28/03/2007, ref: 07.17.0430
2. Biobank Ethics Committee Academic Medical Center Amsterdam, 27/03/2016, ref: 2015_125

Study design

Observational prospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Community

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 cardiac arrest

Intervention

No interventions will be conducted specifically for the sake of this study. Data of the sudden cardiac arrest (SCA) patients will be collected from the emergency medical services, hospital, general practitioner, public pharmacy, and public registries; DNA will be collected from residual material taken for the sake of patient care (e.g., blood samples).

Patients are enrolled in this study when they suffer SCA. They cannot provide informed consent prior to enrolment, because occurrence of SCA is presently unpredictable. Informed consent can also not be obtained during SCA, because SCA is a medical emergency, in which the patients are unconscious. Therefore, informed consent can only be obtained afterwards. Survivors of SCA will therefore be contacted after they have recovered sufficiently to have regained their ability to make an informed decision to provide written consent to participate in this study. If they decide not to participate, the patient will be withdrawn from the study and DNA samples will be destroyed.

Intervention type

Phase

Drug names

Primary outcome measures

1. Causes of SCA are measured by studying genetic material, medication history from the patient's pharmacist, medical data retrieved from the patient's general practitioner and/or treating hospital and (social) environmental data retrieved from the national statistics agency.
2. Survival after out-of-hospital SCA, measured at hospital discharge using hospital records, and 30-day survival using basic civic registry

Secondary outcome measures

Quality of life after surviving SCA is measured using score on Cerebral Performance Category at hospital discharge.

Overall trial start date

01/01/2005

Overall trial end date

01/01/2031

Reason abandoned

Eligibility

Participant inclusion criteria

All patients who suffer out-of-hospital cardiac arrest in the ARREST study region

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

15,000

Participant exclusion criteria

There are no exclusion criteria

Recruitment start date

01/06/2005

Recruitment end date

01/01/2030

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center
Department of Cardiology Meibergdreef 9 1105 AZ Amsterdam The Netherlands
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC)

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31-20-5664678
arrest@amc.uva.nl

Sponsor type

Research organisation

Website

Funders

Funder type

Government

Funder name

European Commission: Horizon 2020

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Netherlands CardioVascular Research Initiative: The Dutch Heart Foundation, Dutch Federation of University Medical Centres, the Netherlands Organisation for Health Research and Development, and the Royal Netherlands Academy of Sciences (PREDICT project)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Netherlands Organization for Scientific Research (NWO)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Dutch Medicines Evaluation Board (MEB/CBG)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

BBMRI-NL

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Dutch Heart Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Physio-Control Inc

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Zoll Medical

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cardiac Science

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

ZonMW

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Laerdal Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal, yearly throughout the study.

IPD Sharing plan:
Not expected to be available, because of privacy considerations: risk of exposing patient identifying information. Data are held at Academic Medical Center, Amsterdam.

Intention to publish date

08/12/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes