ARREST registry: Amsterdam resuscitation studies
| ISRCTN | ISRCTN15255286 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15255286 |
| Secondary identifying numbers | 1 |
- Submission date
- 08/12/2016
- Registration date
- 08/12/2016
- Last edited
- 14/08/2019
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
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)
Contact information
Scientific
Academisch Medisch Centrum
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
 ORCID ID |
0000-0002-7905-5818 |
|---|
Scientific
Academisch Medisch Centrum
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| ORCID ID |
0000-0002-8088-1105 |
|---|
Study information
| Study design | Observational prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | ARREST registry: AmsteRdam REsuscitation STudies |
| Study 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(s) | 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 |
| 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 | Other |
| Primary outcome measure | 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 study start date | 01/01/2005 |
| Overall study end date | 01/01/2031 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 15,000 |
| Participant inclusion criteria | All patients who suffer out-of-hospital cardiac arrest in the ARREST study region |
| 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
Study participating centre
Meibergdreef 9
1105 AZ Amsterdam
The Netherlands
Amsterdam
1105 AZ
Netherlands
Sponsor information
Research organisation
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31-20-5664678 |
|---|---|
| arrest@amc.uva.nl | |
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Government
No information available
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Results and Publications
| Intention to publish date | 08/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 06/08/2014 | 14/08/2019 | Yes | No |
Editorial Notes
14/08/2019: Publication reference added.
23/07/2019: Internal review.
