Clinical trial

AI-POD Clinical Validation Study for Obese Patients

Recruiting now · Not applicable · 5 countries · Registry ID NCT06595134

Recruiting nowNot applicableObservational

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age45 Years to Not listed

SexAll

Healthy volunteersNot listed

ConditionAcute Cardiovascular Disease

Full registry criteria

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

Treatments and study arms

Non Interventional

Other

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)