Validation Study of AI Tools for Predicting Vascular Diseases in Obese Adults Using Cardiac CT Scans and Wearable Technology

What this Trial Is About

Researchers are evaluating the accuracy of AI-POD instruments, including a risk score, clinical decision support system CDSS, and a Citizen App, in obese patients suspected of cardiovascular disease CVD who are scheduled for cardiac CT scans. This prospective, multicentre observational study involves 1200 patients across Europe and aims to improve prediction of CVD progression. The study includes patients with a body mass index BMI over 30 and suspected CVD, with a follow-up period of 2 years. Participants will undergo clinically indicated cardiac CT scans at the start and after 2 years using a photon-counting CT system. Clinical, physical, and laboratory data will be collected over five visits within 2 years, including body measurements, cardiovascular risk factors, echocardiography results, and various blood tests. Half of the participants will be randomly assigned to receive access to the Citizen App and a fitness tracker to record activity, heart rate, nutrition, and sleep data. During the study, participants will attend multiple visits for assessments, including cardiac CT scans and laboratory tests, spaced from day 0 to month 24 with an additional visit at month 60 marking the study end. Data collected will include heart rate, daily steps, body measurements, and clinical lab results to evaluate the AI-POD risk scores prediction accuracy. The study also monitors feasibility and data collection using the Citizen App and fitness tracker, aiming for improved CVD risk assessment in obese patients.

AI-POD Clinical Validation Study for Obese Patients