AI-POD Clinical Validation Study for Obese Patients
AI for the Prediction of Obesity-Related Vascular Diseases - Validation Study
University Hospital, Bonn
1,200 participants
Jul 1, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria15
- Age greater than or equal to 45 years at the time of signing informed consent
- BMI greater than or equal to 30 kg/m2
- Patients with suspected CVD (>15% pretest probability \[ESC guidelines\]), referred for cardiac CT examinations (consisting of coronary calcium scoring and coronary CT angiography)
- Informed consent of the patient
- Hospitalization for unstable angina pectoris or transient ischemic attack or due to congestive heart failure.
- Planned coronary, carotid, or peripheral artery revascularisation known on the day of inclusion
- Presently classified NYHA IV heart failure
- Having uncontrolled diabetes mellitus (HbA1c ≥ 11%) at day of inclusion
- Having uncontrolled hypertension (SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg) as measured at inclusion
- Having severe renal impairment measured as an eGFR < 30 mL/min/1.73 m2 at inclusion
- Alanine aminotransferase (ALT) or alkaline phosphatase (APT) level < 3.0 x the upper limit of normal (ULN)for the reference range
- Total bilirubin level >1.5 x the ULN for the reference range
- History of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
- Previous organ transplantation or awaiting an organ transplant
- Pregnancy or breastfeeding
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Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06595134