Automated Cardiac Arrest Detection and Alerting in Daily Life (DETECT-4b)

November 14, 2024 updated by: Radboud University Medical Center

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population consists of patients with an ICD.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the time of enrollment to the end of the wearing period of the wristband (maximal two years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
The number of true positives devided by the sum of the true positives and false positive cardiac arrest alarms
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)
Expressed as the number of false positive non-cancelled cardiac arrest alarms per user year
From the time of enrollment to the end of the wearing period of the wristband (maximal two years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Corsano Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 14, 2024

First Posted (Estimated)

November 18, 2024

Study Record Updates

Last Update Posted (Estimated)

November 18, 2024

Last Update Submitted That Met QC Criteria

November 14, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 116424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pseudomynized data from the wristband will be made available on a data repository under restricted access.

IPD Sharing Time Frame

IPD and supporting information will be made available when results of the study are published, for 15 years.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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