Technological and Patient-tailored Innovations for Maximizing Effectiveness of Cardiac Arrest Resuscitation

NCT06538155 | Recruiting

• 2 other identifiers: TIME-CARE 264-2024PNRR-POC-2023-123771
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Out-Of-Hospital Cardiac Arrest; Cardiac Arrest

Keywords

out-of-hospital cardiac arrest; cardiac arrest; cardiopulmonary resuscitation; extracorporeal cardiopulmonary resuscitation

Outcome Measures

Primary Outcomes (1)

• Survival

  Hospital discharge (4 weeks for hospital admission)

Study Arms (3)

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.

Device: Wearable device

Patients with cardiac arrest

Adults resuscitated after cardiac arrest or during ongoing cardiopulmonary resuscitation (CPR).

Other: Cardiopulmonary resuscitation; Other: CT scan, TEE exam, or chest X ray

Patients who received a CT scan

Adults who received a chest CT scan for any reasons.

Other: CT scan, TEE exam, or chest X ray

Interventions

Wearable device DEVICE

Wearable devices that are preferentially Food and Drug Administration (FDA) and/or Conformité Européenne (CE) marked

Wearable device users

Cardiopulmonary resuscitation OTHER

Cardiopulmonary resuscitation

Patients with cardiac arrest

CT scan, TEE exam, or chest X ray OTHER

Chest CT scan, transesophageal echocardiogram (TEE) scans, or chest X ray

Patients who received a CT scan; Patients with cardiac arrest

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* 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 ≥18 years resuscitated after cardiac arrest or during ongoing cardiopulmonary resuscitation (CPR). * Patients ≥ 18 years who received a chest CT scan for any reasons.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• \- Patients with severe thorax/mediastinal deformity.
• AIM 3.2 CLINICAL STUDY IN PATIENTS WHO RECEIVED A CHEST CT SCAN
• Adults (≥ 18 years);
• Received a chest CT scan for any reasons;
• Informed consent.

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead
• IRCCS Ospedale San Raffaele: collaborator
• Politecnico di Milano: collaborator
• Azienda Ospedaliera Universitaria "Luigi Vanvitelli" (AOV): collaborator
• Azienda Ospedaliera Universitaria Federico II (AOU Federico II): collaborator

Study Sites (3)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

AOU Policlinico Federico II

Napoli, 80100, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Vanvitelli

Napoli, 80138, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Heart Arrest

Interventions

Wearable Electronic Devices; Cardiopulmonary Resuscitation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies; Resuscitation; Emergency Treatment; Therapeutics

Study Officials

• Alberto Zangrillo, MD

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Landoni, MD

CONTACT

+390226436151; landoni.giovanni@hsr.it

Tommaso Scquizzato, MD

CONTACT

+390226436151; scquizzato.tommaso@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: January 27, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)