AI-POD Clinical Validation Study for Obese Patients
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 smartphon
| Condition(s) | Acute Cardiovascular Disease |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 |
| Ages | 45 Years |
| Sex | All |
| Lead sponsor | University Hospital, Bonn |
| Locations | Vienna, Austria; Leuven, Belgium; Pilsen, Czechia; Bonn, North Rhine-Westphalia, Germany; Mannheim, Germany; Zurich, Switzerland |
| Start date | 2024-07-01 |
| NCT ID | NCT06595134 |
| Official listing | https://clinicaltrials.gov/study/NCT06595134 |