AI-POD Clinical Validation Study for Obese Patients

NCT ID: NCT06595134

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2028-07-31

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 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.

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 CVD who are scheduled for a cardiac CT scan (consisting of calcium scoring and coronary CT angiography) will be included in the study. This clinically indicated cardiac CT scan will serve as a baseline examination, and a second cardiac CT scan will be performed after a follow-up period of 2 years. Both cardiac CT examinations will be performed on a photon-counting CT system (PCCT). In addition to the CT data, clinical data (anthropometry and physical parameters such as body weight, height, age, gender, BMI, waist circumference, waist-to-hip ratio, body impedance analysis, cardiovascular risk factors, medication, previous interventions and operations) will be collected, symptoms and results of echocardiography to determine left ventricular function) as well as laboratory data on (subclinical) inflammation (hsCRP, leukocytes, monocyte activation), lipid disorders (HDL, LDL, total cholesterol, triacylglycerides), glucose homeostasis (HbA1c, fasting glucose, HOMA index), liver and kidney function (creatinine, GFR, GOT/ALAT, GPT/ASAT) are collected at a total of 5 visits over 2 years. Half of all included patients will also be randomised to receive access to the Citizen app and a separate fitness tracker device to record the following data: Activity data such as step count, heart rate, height, weight, gender, age, waist circumference circumference, nutritional data such as calorie intake, nicotine, alcohol, sleep.

Conditions

Acute Cardiovascular Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Arm 1

Standard Care plus Fitnesstracker and Citizen App

Non Interventional

Intervention Type: OTHER

Screening (Day -7 to Day -1) Visit 1 (Day 0) Visit 2 (Month 3 +/- 7 days) Visit 3 (Month 6 +/- 7 days) Visit 4 (Month 12 +/- 7 days) Visit 5 (Month 24 +/- 7 days) Visit 6 (Month 60 +/- 30 days; end of study)

Arm 2

Standard Care

Non Interventional

Intervention Type: OTHER

Screening (Day -7 to Day -1) Visit 1 (Day 0) Visit 2 (Month 3 +/- 7 days) Visit 3 (Month 6 +/- 7 days) Visit 4 (Month 12 +/- 7 days) Visit 5 (Month 24 +/- 7 days) Visit 6 (Month 60 +/- 30 days; end of study)

Interventions

Non Interventional

Screening (Day -7 to Day -1) Visit 1 (Day 0) Visit 2 (Month 3 +/- 7 days) Visit 3 (Month 6 +/- 7 days) Visit 4 (Month 12 +/- 7 days) Visit 5 (Month 24 +/- 7 days) Visit 6 (Month 60 +/- 30 days; end of study)

Intervention Type: OTHER

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Union

OTHER

Sponsor Role: collaborator

University Hospital, Bonn

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Ulrike Attenberger

Director, Clinic for Diagnostik and Interventional Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulrike Attenberger, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

ulrike.attenberger@meduniwien.ac.at

Locations

Medical University Vienna

Vienna, , Austria

Site Status: NOT_YET_RECRUITING

University Hospital Leuven

Leuven, , Belgium

Site Status: NOT_YET_RECRUITING

University Hospital Pilsen

Pilsen, , Czechia

Site Status: RECRUITING

University Hospital Bonn

Bonn, North Rhine-Westphalia, Germany

Site Status: RECRUITING

University Hospital Mannheim

Mannheim, , Germany

Site Status: RECRUITING

University Hospital Zürich

Zurich, , Switzerland

Site Status: NOT_YET_RECRUITING

Countries

Austria; Belgium; Czechia; Germany; Switzerland

Central Contacts

Ulrike Attenberger, Prof. Dr.

Role: CONTACT

ulrike.attenberger@meduniwien.ac.at

+43 (0)140400-48930

Wiebke Fenske, Prof. Dr.

Role: CONTACT

Wiebke.Fenske@bergmannsheil.de

0234 302 6400

Facility Contacts

Christian Loewe, Prof. Dr.

Role: primary

christian.loewe@meduniwien.ac.at

Hilde Bosmans, Prof.

Role: primary

hilde.bosmans@kuleuven.be

Jiri Ferda, Prof. Dr.

Role: primary

ferda@fnplzen.cz

Ulrike Attenberger, Prof. Dr.

Role: primary

Ulrike.Attenberger@ukbonn.de

0228 287 15871

Wiebke Fenske, Prof. Dr.

Role: backup

Wiebke.Fenske@bergmannsheil.de

0234 302 6400

Stefan Schönberg, Prof. Dr.

Role: primary

stefan.schoenberg@umm.de

Hatem Alkadhi, Prof. Dr.

Role: primary

hatem.alkadhi@usz.ch

Other Identifiers

310/23-EP

Identifier Type: -

Identifier Source: org_study_id