AI for the Prediction of Obesity-Related Vascular Diseases (AI-POD) - Validation study

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 1200

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
?Subjects with intermediate-to-high clinical likelihood of CAD, including:
- Those with suspected coronary artery disease (CAD) in symptomatic patients in whom CAD cannot be excluded by clinical assessment alone (> 15% pre-test probability for obstructive CAD based on age, sex, and nature of symptoms according to 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes (see supplemental Table 1).
oPossible conditions are:
?Men with typical angina pectoris symptoms = 40 years
?Women with typical angina pectoris symptoms = 60 years
?Men with atypical angina pectoris symptoms = 50 years
?Women with atypical angina pectoris symptoms = 70 years
?Men with non-anginal symptoms = 60 years
?Men with dyspnoea only or dyspnoea as the primary symptom = 50 years

oOr those with an overall > 15% clinical likelihood of obstructive CAD based on additional consideration of risk modifiers of the PTP estimate (including CVD risk factors, abnormal resting/exercise ECG or LV dysfunction according to 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes (see supplemental Table 2).

? Informed consent of the patient

Exclusion Criteria

General Safety concerns:
? 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 revascularization 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

Study-goal-directed criteria:
? Established CVD as evidenced by at least one of the following events: a history of myocardial infarction,
coronary artery stenting, coronary artery bypass grafting, stroke, or symptomatic peripheral arterial disease
(PAD) (as evidenced by intermittent claudication with ankle-brachial index (ABI) less than 0.85 at rest), or
peripheral arterial revascularization procedure.
? Within the past 3 months previously participated in a weight-loss program
? Are currently enrolled in any other clinical study involving an investigational product or any other type of
medical research judged not to be scientifically or medically compatible with this study
? Are receiving or have received within 3 months prior to screening chronic (> 2 weeks) systemic glucocorticoid
therapy (excluding topical, intraocular, intranasal, intraarticular or inhaled preparations) or have evidence of an
active autoimmune abnormality that has required (within the last 3 months) or is likely to require, in the
opinion of the investigator, concurrent treatment with systemic glucocorticoids
? Have overweight or obesity induced by other endocrinologic disorders (i.e. Cushing Syndrome) or diagnosed
monogenetic or syndromic forms of obesity (i.e. Prader Willi Syndrome, Melanocortin 4 Receptor deficiency)
? Have a self-reported change in body weight > 5 kg within 3 months prior screening
? Have a prior or planned endoscopic, device-based or surgical treatment for obesity during the expected
timeline of the study
? Have a history of any other condition (i.e. drug or alcohol abuse, diagnosed eating disorder, or other psychiatric
disorder) that, in the opinion of the investigator, may preclude the participant from completing the protocol
? Known allergic reactions to CT contrast media

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is an improved accuracy in prediction of CVD progression by using the AI-POD risk score compared to standard risk assessment.

Secondary Outcome Measures

Name	Time	Method
The secondary study objective is to validate a tool (Citizen App) to support change in lifestyle. Change in lifestyle will be assessed through tailored questionnaires and by the potential change in anthropometric and biochemical parameters at the 12-month follow-up and by the potential change in the AI-POD risk score at the 24-month follow-up in patients with and without adherence to the Citizen App.