Status:
RECRUITING
AI-POD Clinical Validation Study for Obese Patients
Lead Sponsor:
University Hospital, Bonn
Collaborating Sponsors:
European Union
Conditions:
Acute Cardiovascular Disease
Eligibility:
All Genders
45+ years
Brief 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 ...
Detailed Description
The clinical validation study of the AI-POD instruments (risk score, CDSS, Citizen App) is designed as a prospective, multicentre observational study. Obese patients (BMI \>30 kg/m2) with suspected CV...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT06595134
Start Date
July 1 2024
End Date
July 1 2028
Last Update
September 19 2024
Active Locations (6)
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1
Medical University Vienna
Vienna, Austria, 1090
2
University Hospital Leuven
Leuven, Belgium, 3000
3
University Hospital Pilsen
Pilsen, Czechia, 323 00
4
University Hospital Bonn
Bonn, North Rhine-Westphalia, Germany, 53127