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RECRUITING
NCT06595134

AI-POD Clinical Validation Study for Obese Patients

Sponsor: University Hospital, Bonn

View on ClinicalTrials.gov

Summary

The study is aimed at patients who suffer from severe obesity and receive a computerised tomography (CT) scan of the heart. A total of 1200 patients across Europe are to take part in the study. It is a multi-centre, controlled, open, randomised study. As part of the study, a citizen app will be installed on a smartphone for randomly selected study participants. A fitness tracker will also be issued so that certain parameters, such as heart rate and daily number of steps, can be recorded.

Official title: AI for the Prediction of Obesity-Related Vascular Diseases - Validation Study

Key Details

Gender

All

Age Range

45 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1200

Start Date

2024-07-01

Completion Date

2028-07

Last Updated

2024-09-19

Healthy Volunteers

Not specified

Interventions

OTHER

Non Interventional

Screening (Day -7 to Day -1) Visit 1 (Day 0) Visit 2 (Month 3 +/- 7 days) Visit 3 (Month 6 +/- 7 days) Visit 4 (Month 12 +/- 7 days) Visit 5 (Month 24 +/- 7 days) Visit 6 (Month 60 +/- 30 days; end of study)

Locations (6)

Medical University Vienna

Vienna, Austria

University Hospital Leuven

Leuven, Belgium

University Hospital Pilsen

Pilsen, Czechia

University Hospital Bonn

Bonn, North Rhine-Westphalia, Germany

University Hospital Mannheim

Mannheim, Germany

University Hospital Zürich

Zurich, Switzerland