Automated Cardiac Arrest Detection and Alerting in Daily Life

NCT06692374 | Not Yet Recruiting

• 1 other identifier: 116424
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiac Arrest (CA); Sudden Death, Cardiac

Keywords

Automated cardiac arrest detection; Wearable; Photoplethysmography; Sudden Cardiac Death

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  From the time of enrollment to the end of the wearing period of the wristband (maximal two years)

• False positive alarm rate

  From the time of enrollment to the end of the wearing period of the wristband (maximal two years)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of patients with an ICD.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Corsano Health: collaborator

Study Sites (1)

RadboudUMC

Nijmegen, Gelderland, 6525GA, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 38395540 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Heart Arrest; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 18, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: November 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD and supporting information will be made available when results of the study are published, for 15 years.

Locations

NL (1)