AI-POD Clinical Validation Study for Obese Patients
Recruiting · NCT06595134 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Non Interventional
What this trial is about
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.
Who can take part
Age range
45 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- Any of the following CV conditions within 2 months prior to study inclusion: myocardial infarction, stroke,
- 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
Where it is running
6 locations listed.
- University Hospital Leuven - Leuven, Belgium
- University Hospital Mannheim - Mannheim, Germany
- University Hospital Pilsen - Pilsen, Czechia
- Medical University Vienna - Vienna, Austria
- University Hospital Zürich - Zurich, Switzerland
- University Hospital Bonn - Bonn, North Rhine-Westphalia, Germany