AI-POD Clinical Validation Study for Obese Patients
ConditionAcute Cardiovascular Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45+
SponsorUniversity Hospital, Bonn
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Non Interventional
Treatment groups
1,200 Participants
are divided into 2 treatment groupsLocations
6Austria
Medical University Vienna1090, Vienna Austria
Belgium
University Hospital Leuven3000, Leuven Belgium
Czechia
University Hospital Pilsen323 00, Pilsen Czechia
Germany
University Hospital Bonn53127, BonnNorth Rhine-Westphalia, Germany
Sponsors and collaborators
University Hospital, Bonn
Lead sponsor
European Union
Collaborator
Source ClinicalTrials.gov