Cardiac Arrest (CA)DETECT-4bNCT06692374
Automated Cardiac Arrest Detection and Alerting in Daily Life
An observational study of Cardiac Arrest (CA) and Sudden Death, Cardiac, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Surviving a cardiac arrest that happens outside the hospital depends on quickly recognizing the event and immediately starting CPR. Survival rates have improved when cardiac arrest is witnessed, but when it isn't, help often arrives too late. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest (CA), Sudden Death, Cardiac
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2025to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients with an ICD.
Who may be able to join
- Patients with an implantable cardioverter defibrillator (ICD)
- Age 18 years or older
- Fitting the wristband
- In possession of a smartphone that is compatible with the wristband
Who cannot join
- Known hemodynamically relevant bilateral subclavian artery stenosis
- Medical issues that interfere with wearing of the wristband (e.g. skin disorders)
- Insufficient skills to operate with the device/app
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
RadboudUMC
Nijmegen, Gelderland, 6525GA
Judith J Bonnes, MD PhD, +31 (0)24 3616785, judith.bonnes@radboudumc.nl
About this study
Official title: Smartwatch-based Automated Cardiac Arrest Detection and Activation of the Emergency Medical Chain: Validation in a Home Setting
Surviving a cardiac arrest that happens outside the hospital depends on quickly recognizing the event and immediately starting CPR. Survival rates have improved when cardiac arrest is witnessed, but when it isn't, help often arrives too late. Wearable biosensors, like special wristbands, could detect cardiac arrest automatically and alert emergency responders, providing faster help.
In the already finished DETECT-1 study, the investigators developed a system that uses wrist-worn sensors to identify cardiac arrest. The goal of the current study is to test how well this system works in people who have an implantable cardioverter defibrillator (ICD). An ICD is a device that monitors and treats dangerous heart rhythms. Study participants will wear a medical wristband with sensors that monitor the heartrate and movement during their daily activities to see if the system accurately detects cardiac arrest.
Read the detailed description
Survival from out-of-hospital cardiac arrest (OHCA) depends on fast recognition of cardiac arrest and immediate initiation of cardiopulmonary resuscitation (CPR). While survival chances for witnessed OHCA have increased, unwitnessed cases still often receive help too late. Wearable biosensor technology with the functionality of automated cardiac arrest detection and activation of the emergency medical chain would offer a potential solution to provide early help. In the recently published DETECT-1 study, an algorithm for automated cardiac arrest detection using wrist-derived photoplethysmography (PPG) was recently developed.
The current study is a prospective multicenter observational cohort study to validate the sensitivity of the developed cardiac arrest detection algorithm in patients with an implantable cardioverter defibrillator (ICD) during daily life. The study population includes patients with an ICD. Study participants will wear a medical wristband with PPG and accelerometer sensors during daily life.
- Conditions
- Cardiac Arrest (CA), Sudden Death, Cardiac
- Keywords
- Automated cardiac arrest detection, Wearable, Photoplethysmography, Sudden Cardiac Death
- Medical subject headings
- Heart Arrest, Death, Sudden, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity for cardiac arrest detection
The number of correctly identified cardiac arrest events by the algorithm devided by the total number of cardiac arrest events.
Measured: From the time of enrollment to the end of the wearing period of the wristband (maximal two years)
Secondary outcomes (2)
Positive predictive value for cardiac arrest detection
The number of true positives devided by the sum of the true positives and false positive cardiac arrest alarms
Measured: From the time of enrollment to the end of the wearing period of the wristband (maximal two years)
False positive alarm rate
Expressed as the number of false positive non-cancelled cardiac arrest alarms per user year
Measured: From the time of enrollment to the end of the wearing period of the wristband (maximal two years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Arrest (CA)Studies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Corsano Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692374
- Sponsor's protocol ID
- 116424
- Acronym
- DETECT-4b
- Status last verified
- Oct 2024
- First submitted
- 12 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudomynized data from the wristband will be made available on a data repository under restricted access.
Publications
Edgar R, Scholte NTB, Ebrahimkheil K, Brouwer MA, Beukema RJ, Mafi-Rad M, Vernooy K, Yap SC, Ronner E, van Mieghem N, Boersma E, Stas PC, van Royen N, Bonnes JL. Automated cardiac arrest detection using a photoplethysmography wristband: algorithm development and validation in patients with induced circulatory arrest in the DETECT-1 study. Lancet Digit Health. 2024 Mar;6(3):e201-e210. doi: 10.1016/S2589-7500(23)00249-2.
PubMed 38395540
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartwatch-based Automated Cardiac Arrest Detection and Activation of the Emergency Medical Chain: Validation in a Home Setting
- ClinicalTrials.gov ID
- NCT06692374
- Acronym / sponsor ID
- DETECT-4b / 116424
- Conditions
- Cardiac Arrest (CA), Sudden Death, Cardiac
- Keywords
- Automated cardiac arrest detection, Wearable, Photoplethysmography, Sudden Cardiac Death
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Corsano Health
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Surviving a cardiac arrest that happens outside the hospital depends on quickly recognizing the event and immediately starting CPR. Survival rates have improved when cardiac arrest is witnessed, but when it isn't, help often arrives too late. Wearable biosensors, like special wristbands, could detect cardiac arrest automatically and alert emergency responders, providing faster help.
In the already finished DETECT-1 study, the investigators developed a system that uses wrist-worn sensors to identify cardiac arrest. The goal of the current study is to test how well this system works in people who have an implantable cardioverter defibrillator (ICD). An ICD is a device that monitors and treats dangerous heart rhythms. Study participants will wear a medical wristband with sensors that monitor the heartrate and movement during their daily activities to see if the system accurately detects cardiac arrest.
Detailed description
Survival from out-of-hospital cardiac arrest (OHCA) depends on fast recognition of cardiac arrest and immediate initiation of cardiopulmonary resuscitation (CPR). While survival chances for witnessed OHCA have increased, unwitnessed cases still often receive help too late. Wearable biosensor technology with the functionality of automated cardiac arrest detection and activation of the emergency medical chain would offer a potential solution to provide early help. In the recently published DETECT-1 study, an algorithm for automated cardiac arrest detection using wrist-derived photoplethysmography (PPG) was recently developed.
The current study is a prospective multicenter observational cohort study to validate the sensitivity of the developed cardiac arrest detection algorithm in patients with an implantable cardioverter defibrillator (ICD) during daily life. The study population includes patients with an ICD. Study participants will wear a medical wristband with PPG and accelerometer sensors during daily life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients with an ICD.
Key inclusion criteria (4 listed)
- Patients with an implantable cardioverter defibrillator (ICD)
- Age 18 years or older
- Fitting the wristband
- In possession of a smartphone that is compatible with the wristband
Key exclusion criteria (3 listed)
- Known hemodynamically relevant bilateral subclavian artery stenosis
- Medical issues that interfere with wearing of the wristband (e.g. skin disorders)
- Insufficient skills to operate with the device/app
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity for cardiac arrest detection
Time frame: From the time of enrollment to the end of the wearing period of the wristband (maximal two years)
The number of correctly identified cardiac arrest events by the algorithm devided by the total number of cardiac arrest events.
2 secondary outcomes
Positive predictive value for cardiac arrest detection
Time frame: From the time of enrollment to the end of the wearing period of the wristband (maximal two years)
False positive alarm rate
Time frame: From the time of enrollment to the end of the wearing period of the wristband (maximal two years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Results publication: PubMed 38395540Edgar R, Scholte NTB, Ebrahimkheil K, Brouwer MA, Beukema RJ, Mafi-Rad M, Vernooy K, Yap SC, Ronner E, van Mieghem N, Boersma E, Stas PC, van Royen N, Bonnes JL. Automated cardiac arrest detection using a photoplethysmography wristband: algorithm development and validation in patients with induced circulatory arrest in the DETECT-1 study. Lancet Digit Health. 2024 Mar;6(3):e201-e210. doi: 10.1016/S2589-7500(23)00249-2.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pseudomynized data from the wristband will be made available on a data repository under restricted access.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest (CA) and Sudden Death, Cardiac, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity for cardiac arrest detection (time frame: From the time of enrollment to the end of the wearing period of the wristband (maximal two years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06692374, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.