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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device, Other
Study Type: Observational
SUMMARY

Out-of-hospital cardiac arrest (OHCA) affects 275,000 people in Europe every year. In Italy alone, 50,000 people experience OHCA annually, with only 9% surviving. Half of the survivors suffer severe brain damage. Immediate CPR and defibrillation by bystanders before the ambulance arrives can save lives, but often, CPR starts only when the ambulance gets there. Additionally, half of all OHCAs occur when the person is alone, causing delays in recognizing the emergency, calling for help, and starting lifesaving actions. Effective chest compressions and defibrillation are crucial but are often not done correctly or are not customized for each patient. Current guidelines recommend the same approach for everyone, which doesn't consider individual needs. To tackle these issues, we plan to develop artificial intelligence (AI) algorithms, smartphone apps, and new devices. Our main goal is to create tools and technologies to improve the recognition of OHCA and provide timely and effective interventions, ultimately reducing the impact of OHCA and improving survival rates. First, we aim to create an AI algorithm that can predict major cardiovascular events like heart attacks or cardiac arrests minutes, hours, or days before they happen. We will collect data from wearable devices to train and validate this algorithm, helping us identify individuals at risk. By alerting these individuals, they can seek emergency care and receive treatment before a cardiac arrest occurs. We will also work on recognizing OHCA cases from surveillance camera footage when they happen to people who are alone. Second, to increase the rate of CPR and defibrillation before ambulances arrive, we will develop a smartphone app that geolocates and alerts nearby citizens to act as first responders. The app will guide them on how to quickly find a defibrillator and use it. Third, to find the best spots on the chest for compressions and defibrillation, we will study chest scans from CTs and echocardiograms in both elective patients and cardiac arrest victims. This will help us understand the effects of compressing different heart structures and develop a sensor to determine the optimal positions for compressions and defibrillator pads. Our multidisciplinary team of clinicians, researchers, and engineers will conduct experimental, simulation, and observational studies to develop these technologies, evaluate their potential for patents, design a plan for their use, and test their effectiveness in preventing and recognizing OHCA. We believe that by improving each step in the chain of survival-preventing cardiac events, early recognition, timely CPR and defibrillation, and high-quality advanced resuscitation-we can significantly improve treatment times and reduce the global death and disability rates caused by OHCA.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

• 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.

• Adults (≥ 18 years);

• Received a chest CT scan for any reasons;

• Informed consent.

Locations
Other Locations
Italy
IRCCS Ospedale San Raffaele
RECRUITING
Milan
AOU Policlinico Federico II
NOT_YET_RECRUITING
Napoli
Azienda Ospedaliera Universitaria Vanvitelli
NOT_YET_RECRUITING
Napoli
Contact Information
Primary
Giovanni Landoni, MD
landoni.giovanni@hsr.it
+390226436151
Backup
Tommaso Scquizzato, MD
scquizzato.tommaso@hsr.it
+390226436151
Time Frame
Start Date: 2025-01-27
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 500
Treatments
Wearable device users
Healthy volunteers (every adult individual with no history of cardiovascular events willing to contribute to the project) and patients who experienced major cardiovascular events (i.e., myocardial infarction or cardiac arrest). Both groups must have worn a wearable device or used a smartphone able to collect healthcare data and biosignals.
Patients with cardiac arrest
Adults resuscitated after cardiac arrest or during ongoing cardiopulmonary resuscitation (CPR).
Patients who received a CT scan
Adults who received a chest CT scan for any reasons.
Related Therapeutic Areas
Sponsors
Collaborators: IRCCS Ospedale San Raffaele, Azienda Ospedaliera Universitaria Luigi Vanvitelli (AOV), Politecnico di Milano, Azienda Ospedaliera Universitaria Federico II (AOU Federico II)
Leads: Università Vita-Salute San Raffaele

This content was sourced from clinicaltrials.gov