AI-POD Clinical Validation Study for Obese Patients

Launched by UNIVERSITY HOSPITAL, BONN · Sep 10, 2024

Keywords

ClinConnect Summary

The AI-POD Clinical Validation Study is a research project designed to help improve the care of patients who are severely obese and have heart-related issues. This study will involve 1,200 participants from different locations across Europe who are undergoing a special heart scan called a computerized tomography (CT) scan. If you are at least 45 years old, have a body mass index (BMI) of 30 or more, and have been referred for this heart scan due to suspected cardiovascular disease, you might be eligible to join the study.

Participants in the study will receive a smartphone app and a fitness tracker to record important health information, like heart rate and daily activity levels. This information will help researchers understand how obesity affects heart health and how to improve treatment for patients with similar conditions. It's important to note that certain health issues, such as recent heart attacks, strokes, or uncontrolled diabetes, may prevent someone from participating. If you decide to take part, you'll be contributing to valuable research that could lead to better treatments for obesity and heart disease in the future.

Gender

ALL

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