MedTrace Logo

AI-POD Clinical Validation Study for Obese Patients

NCT06595134 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Acute Cardiovascular Disease

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)

Sponsors & Collaborators

  • European Union

    collaborator OTHER

  • University Hospital, Bonn

    lead OTHER

Principal Investigators

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2028-07-31
Completion
2028-07-31

Countries

  • Austria
  • Belgium
  • Czechia
  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06595134 on ClinicalTrials.gov