Status:
RECRUITING
Technological and Patient-tailored Innovations for Maximizing Effectiveness of Cardiac Arrest Resuscitation
Lead Sponsor:
Università Vita-Salute San Raffaele
Collaborating Sponsors:
IRCCS Ospedale San Raffaele
Politecnico di Milano
Conditions:
Out-Of-Hospital Cardiac Arrest
Cardiac Arrest
Eligibility:
All Genders
18+ years
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 b...
Detailed Description
Out-of-hospital cardiac arrest (OHCA) annually affects 275000 individuals in Europe. In Italy alone, 50000 persons suffer from OHCA each year and only 9% survives1. Half of the survivors are left with...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 27 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06538155
Start Date
January 27 2025
End Date
August 31 2026
Last Update
August 6 2025
Active Locations (3)
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1
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
2
AOU Policlinico Federico II
Napoli, Italy, 80100
3
Azienda Ospedaliera Universitaria Vanvitelli
Napoli, Italy, 80138