Innovative technologies to improve cardiac arrest resuscitation effectiveness

Technological and Patient-tailored Innovations for Maximizing Effectiveness of Cardiac Arrest Resuscitation: the TIME-CARE Project

This study is testing new technology, like smartphone apps and wearable devices, to see if it can help improve CPR and defibrillation for people who have a cardiac arrest outside of the hospital.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Università Vita-Salute San Raffaele (other)
• Locations: 3 sites (Milan and 2 other locations)
• Trial ID: NCT06538155 on ClinicalTrials.gov

What this trial studies

This study focuses on enhancing the effectiveness of resuscitation for out-of-hospital cardiac arrest (OHCA) through the development of artificial intelligence algorithms, smartphone applications, and novel devices. It aims to improve the recognition of OHCA and ensure timely and effective interventions by tailoring cardiopulmonary resuscitation (CPR) and defibrillation techniques to individual patient needs. The study will collect biosignals from wearable devices to predict major cardiovascular events and assess the impact of these innovations on survival rates and brain health. By addressing the current limitations in CPR practices, the study seeks to significantly improve outcomes for patients experiencing OHCA.

Who should consider this trial

Good fit: Ideal candidates include healthy volunteers aged 18-70 or patients who have experienced major cardiovascular events and are users of smartwatches or smartphones that collect health data.

Not a fit: Patients who are unable to use wearable devices or have a history of cardiovascular events that do not align with the study's focus may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates and reduced brain damage for patients experiencing out-of-hospital cardiac arrest.

How similar studies have performed: Other studies have shown promise in using technology and tailored approaches to improve CPR outcomes, but this specific combination of AI and patient-tailored resuscitation is relatively novel.

Eligibility criteria

AIM 1: PREDICTION AND RECOGNITION OF CARDIAC ARREST AIM 1.1: PREDICT A MAJOR CARDIOVASCULAR EVENT

Inclusion criteria:

* Age 18-70 years;
* Being a healthy volunteer (i.e., an individual with no history of cardiovascular events willing to contribute to the project) or a patient (survivors and non-survivors) who experienced major cardiovascular events (i.e., myocardial infarction or cardiac arrest);
* Users of a smartwatch or smartphone that continuously and automatically collect health data;
* Informed consent.

Exclusion criteria:

* Impossibility to access/export data;
* User did not wear the wearable device for periods longer than 24 hours;
* User did not wear the wearable device in the 4 weeks preceding the event.

AIM 1.2 CARDIAC ARREST DETECTION FROM VIDEOS No patient involved.

AIM 2: TECHNOLOGIES TO INCREASE CPR AND DEFIBRILLATION USE BEFORE AMBULANCE ARRIVAL No patient involved.

AIM 3: PATIENT-TAILORED RESUSCITATION AIM 3.1: CLINICAL STUDY IN PATIENTS WHO RECEIVED CPR

Inclusion criteria:

* Adults (≥ 18 years);
* Patients suffering a non-traumatic cardiac arrest treated with chest compressions (both survivors and non-survivors);
* Received a TEE, chest x-ray, or chest CT scan as the standard clinical assessment following cardiac arrest;
* Informed consent.

Exclusion criteria:

\- Patients with severe thorax/mediastinal deformity.

AIM 3.2 CLINICAL STUDY IN PATIENTS WHO RECEIVED A CHEST CT SCAN

Inclusion criteria:

* Adults (≥ 18 years);
* Received a chest CT scan for any reasons;
* Informed consent.

Exclusion criteria:

\- Patients with severe thorax/mediastinal deformity.

AIM 3.3 MACHINE LEARNING (ML) ALGORITHM No patient involved.

Where this trial is running

Milan and 2 other locations

• IRCCS Ospedale San Raffaele — Milan, Italy (RECRUITING)
• AOU Policlinico Federico II — Naples, Italy (NOT_YET_RECRUITING)
• Azienda Ospedaliera Universitaria Vanvitelli — Naples, Italy (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Alberto Zangrillo, MD — IRCCS Ospedale San Raffaele
• Study coordinator: Giovanni Landoni, MD

Conditions: Out-Of-Hospital Cardiac Arrest, Cardiac Arrest, out-of-hospital cardiac arrest, cardiac arrest, cardiopulmonary resuscitation, extracorporeal cardiopulmonary resuscitation