Validation of AI tools for obese patients with heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on obese patients with suspected cardiovascular disease who are scheduled for a cardiac CT scan. A total of 1200 participants across multiple centers in Europe will undergo baseline and follow-up cardiac CT scans over two years. The study will collect extensive clinical and laboratory data, and half of the participants will use a citizen app and fitness tracker to monitor their health metrics. The aim is to validate AI instruments designed to assess cardiovascular risk in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospital Pilsen
  Pilsen, Czechia Recruiting
• University Hospital Bonn
  Bonn, North Rhine-Westphalia, Germany Recruiting
• University Hospital Mannheim
  Mannheim, Germany Recruiting
• Medical University Vienna
  Vienna, Austria Not yet recruiting
• University Hospital Leuven
  Leuven, Belgium Not yet recruiting
• University Hospital Zürich
  Zurich, Switzerland Not yet recruiting

Study contacts

• Principal investigator: Ulrike Attenberger, Prof. Dr. — ulrike.attenberger@meduniwien.ac.at
• Study coordinator: Ulrike Attenberger, Prof. Dr.
• Email: ulrike.attenberger@meduniwien.ac.at
• Phone: +43 (0)140400-48930

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.