Actively Recruiting
AI for the Prediction of Obesity-Related Vascular Diseases - Validation Study
Led by University Hospital, Bonn · Updated on 2024-09-19
1200
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Bonn
Lead Sponsor
E
European Union
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy of AI-POD instruments, including a risk score, clinical decision support system (CDSS), and a Citizen App, in obese patients suspected of cardiovascular disease (CVD) who are scheduled for cardiac CT scans. This prospective, multicentre observational study involves 1200 patients across Europe and aims to improve prediction of CVD progression. The study includes patients with a body mass index (BMI) over 30 and suspected CVD, with a follow-up period of 2 years. Participants will undergo clinically indicated cardiac CT scans at the start and after 2 years using a photon-counting CT system. Clinical, physical, and laboratory data will be collected over five visits within 2 years, including body measurements, cardiovascular risk factors, echocardiography results, and various blood tests. Half of the participants will be randomly assigned to receive access to the Citizen App and a fitness tracker to record activity, heart rate, nutrition, and sleep data. During the study, participants will attend multiple visits for assessments, including cardiac CT scans and laboratory tests, spaced from day 0 to month 24 with an additional visit at month 60 marking the study end. Data collected will include heart rate, daily steps, body measurements, and clinical lab results to evaluate the AI-POD risk score's prediction accuracy. The study also monitors feasibility and data collection using the Citizen App and fitness tracker, aiming for improved CVD risk assessment in obese patients.
CONDITIONS
Brief Title
AI-POD Clinical Validation Study for Obese Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than or equal to 45 years at the time of signing informed consent
- Body mass index (BMI) greater than or equal to 30 kg/m2
- Patients with suspected cardiovascular disease with more than 15% pretest probability
- Scheduled for cardiac CT examinations including coronary calcium scoring and coronary CT angiography
- Provided informed consent to participate
You will not qualify if you...
- Myocardial infarction, stroke, or hospitalization for unstable angina, transient ischemic attack, or congestive heart failure within 2 months before study inclusion
- Planned coronary, carotid, or peripheral artery revascularisation known at inclusion
- Presently classified New York Heart Association class IV heart failure
- Uncontrolled diabetes mellitus (HbA1c ≥ 11%) at inclusion
- Uncontrolled hypertension (systolic ≥ 160 mmHg or diastolic ≥ 100 mmHg) at inclusion
- Severe renal impairment (eGFR < 30 mL/min/1.73 m2) at inclusion
- Alanine aminotransferase (ALT) or alkaline phosphatase (APT) levels ≥ 3 times the upper limit of normal
- Total bilirubin level > 1.5 times the upper limit of normal
- History of active or untreated malignancy or remission for less than 5 years
- Previous organ transplantation or awaiting transplant
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline and after 2 years
Participants undergo clinically indicated cardiac CT scans including calcium scoring and coronary CT angiography using a photon-counting CT system to assess cardiovascular status.
2 visits (in-person) at Day 0 and Month 24
Duration - 2 years
Participants have clinical, laboratory, and physical data collected including anthropometry, cardiovascular risk factors, echocardiography, and blood tests over 2 years to monitor health status and validate AI-POD instruments.
5 visits over 2 years (Day 0, Month 3, Month 6, Month 12, Month 24)
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.
W
Wiebke Fenske, Prof. Dr.
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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