Actively Recruiting
AI-POD Clinical Validation Study for Obese Patients
Led by University Hospital, Bonn · Updated on 2024-09-19
1200
Participants Needed
6
Research Sites
208 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Bonn
Lead Sponsor
E
European Union
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 a multi-centre, controlled, open, randomised study. As part of the study, a citizen app will be installed on a smartphone for randomly selected study participants. A fitness tracker will also be issued so that certain parameters, such as heart rate and daily number of steps, can be recorded.
CONDITIONS
Official Title
AI-POD Clinical Validation Study for Obese Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 45 years or older at the time of consent
- Body mass index (BMI) of 30 kg/m2 or higher
- Suspected cardiovascular disease with more than 15% pretest probability according to ESC guidelines
- Scheduled for cardiac CT examinations including coronary calcium scoring and coronary CT angiography
- Provided informed consent to participate
You will not qualify if you...
- Experienced myocardial infarction, stroke, unstable angina, transient ischemic attack, or hospitalization due to heart failure within 2 months before inclusion
- Planned coronary, carotid, or peripheral artery revascularisation known at inclusion
- Classified as NYHA class IV heart failure
- Uncontrolled diabetes with HbA1c 11% or higher at inclusion
- Uncontrolled hypertension with systolic blood pressure 160 mmHg or higher and/or diastolic blood pressure 100 mmHg or higher at inclusion
- Severe renal impairment with eGFR less than 30 mL/min/1.73 m2 at inclusion
- Alanine aminotransferase (ALT) or alkaline phosphatase (APT) levels greater than 3 times the upper limit of normal
- Total bilirubin level greater than 1.5 times the upper limit of normal
- History of active or untreated malignancy or remission from significant malignancy less than 5 years
- Previous organ transplantation or awaiting organ transplant
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Medical University Vienna
Vienna, Austria, 1090
Not Yet Recruiting
2
University Hospital Leuven
Leuven, Belgium, 3000
Not Yet Recruiting
3
University Hospital Pilsen
Pilsen, Czechia, 323 00
Actively Recruiting
4
University Hospital Bonn
Bonn, North Rhine-Westphalia, Germany, 53127
Actively Recruiting
5
University Hospital Mannheim
Mannheim, Germany, 68167
Actively Recruiting
6
University Hospital Zürich
Zurich, Switzerland, 8091
Not Yet Recruiting
Research Team
U
Ulrike Attenberger, Prof. Dr.
CONTACT
W
Wiebke Fenske, Prof. Dr.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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