AI-POD Clinical Validation Study for Obese Patients

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.

Eligibility

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

Conditions2

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