AI tool to predict heart vessel disease in people with severe obesity
Studies an AI tool using heart CT scans in adults with severe obesity.
Plain-language title generated from the registry record
Registry title: AI-POD Clinical Validation Study for Obese Patients
Key facts
- Where
- Leuven, BelgiumSee the site
Where in Belgium
- University Hospital LeuvenLeuven, BelgiumNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Bonn
- Trial code
- NCT06595134
- Record updated
- 19 September 2024
- Original description
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.Read full original descriptionShow less
AI for the Prediction of Obesity-Related Vascular Diseases - Validation Study
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.
Inclusion: 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.
Exclusion: Any of the following CV conditions within 2 months prior to study inclusion: myocardial infarction, stroke,; Previous organ transplantation or awaiting an organ transplant; Hospitalization for unstable angina pectoris or transient ischemic attack or due to congestive heart failure; Presently classified NYHA IV heart failure; Having uncontrolled hypertension (SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg) as measured at inclusion; History of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years; Having uncontrolled diabetes mellitus (HbA1c ≥ 11%) at day of 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; Planned coronary, carotid, or peripheral artery revascularisation known on the day of inclusion; Pregnancy or breastfeeding.