NCT06595134Recruiting
AI-POD Clinical Validation Study for Obese Patients
AI for the Prediction of Obesity-Related Vascular Diseases - Validation Study
Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1200 (estimated)
- First submitted
- 13 May 2024
- Start date
- 1 Jul 2024
- Primary completion date
- Jul 2028
- Lead sponsor
- University Hospital, Bonn
- Diseases
- Obesity
- NCT number
- NCT06595134
What you commit to
- Study type: Observational
- Planned participants: 1200
- From 1 Jul 2024 to the primary completion date, Jul 2028
- 6 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any of the following CV conditions within 2 months prior to study inclusion: myocardial infarction, stroke,
- Previous organ transplantation or awaiting an organ transplant
Other illness
- Hospitalization for unstable angina pectoris or transient ischemic attack or due to congestive heart failure.
- Presently classified NYHA IV heart failure
- Having uncontrolled hypertension (SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg) as measured at inclusion
- History of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
Lab values
- Having uncontrolled diabetes mellitus (HbA1c ≥ 11%) at day of 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
Other
- Planned coronary, carotid, or peripheral artery revascularisation known on the day of inclusion
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 45 years to - · Sex: All
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Not yet recruiting |
| University Hospital Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Not yet recruiting |
| University Hospital Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Not yet recruiting |
| University Hospital Pilsen Coordinator of this site? Confirm its status | Pilsen | Czechia | Recruiting |
| University Hospital Bonn Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| University Hospital Mannheim Coordinator of this site? Confirm its status | Mannheim | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.