Validation of AI tools for obese patients with heart disease

AI for the Prediction of Obesity-Related Vascular Diseases - Validation Study

This study is testing if new AI tools can help track heart health in obese patients with heart disease who are getting a cardiac CT scan.

Quick facts

• Study type: Observational
• Enrollment: 1200 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: University Hospital, Bonn (other)
• Locations: 6 sites (Vienna and 5 other locations)
• Trial ID: NCT06595134 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are obese individuals aged 45 and older with a BMI of 30 kg/m2 or higher and suspected cardiovascular disease.

Not a fit: Patients with recent severe cardiovascular events or uncontrolled diabetes and hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the management and treatment of obese patients at risk for cardiovascular disease through improved risk assessment and monitoring.

How similar studies have performed: Similar studies utilizing AI for cardiovascular risk assessment have shown promise, indicating potential for success in this novel approach.

Eligibility 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

Where this trial is running

Vienna and 5 other locations

• Medical University Vienna — Vienna, Austria (NOT_YET_RECRUITING)
• University Hospital Leuven — Leuven, Belgium (NOT_YET_RECRUITING)
• University Hospital Pilsen — Pilsen, Czechia (RECRUITING)
• University Hospital Bonn — Bonn, North Rhine-Westphalia, Germany (RECRUITING)
• University Hospital Mannheim — Mannheim, Germany (RECRUITING)
• University Hospital Zürich — Zurich, Switzerland (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Ulrike Attenberger, Prof. Dr. — [e-mail]
• Study coordinator: Ulrike Attenberger, Prof. Dr.

Conditions: Acute Cardiovascular Disease, Obesity, Heart CT, Artificial Intelligence