AI-POD Clinical Validation Study for Obese Patients

NCT06595134 | Recruiting

• 1 other identifier: 310/23-EP
• Study Type: observational
• Target: 1,200
• Locations: 5 countries
• Sites: 6

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.

Conditions

Acute Cardiovascular Disease

Keywords

Obesity, Heart CT, Artificial Intelligence

Outcome Measures

Primary Outcomes (3)

• An improved accuracy in prediction of CVD progression by us-ing the AI-POD risk score

  Change in plaque volume

  Between Visit 1 and Visit 5 (Day 0 and Month 24)

• An improved accuracy in prediction of CVD progression by us-ing the AI-POD risk score

  Change in plaque com-position/CAC

  Between Visit 1 and Visit 5 (Day 0 and Month 24)

• An improved accuracy in prediction of CVD progression by us-ing the AI-POD risk score

  Change in luminal stenosis

  Between Visit 1 and Visit 5 (Day 0 and Month 24)

Secondary Outcomes (10)

• To validate the Citizen App, to assess the improvement of AI-POD risk score Accuracy and feasibility of collecting data with citizen App

  After 2 Years

• To validate the Citizen App, to assess the improvement of AI-POD risk score Accuracy and feasibility of collecting data with citizen App

  After 2 Years

• To validate the Citizen App, to assess the improvement of AI-POD risk score Accuracy and feasibility of collecting data with citizen App

  After 2 Years

• To validate the Citizen App, to assess the improvement of AI-POD risk score Accuracy and feasibility of collecting data with citizen App

  After 2 Years

• To validate the Citizen App, to assess the improvement of AI-POD risk score Accuracy and feasibility of collecting data with citizen App

  After 2 Years

Study Arms (2)

Arm 1

Standard Care plus Fitnesstracker and Citizen App

Other: Non Interventional

Arm 2

Standard Care

Other: Non Interventional

Interventions

Non Interventional 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 1; Arm 2

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese patients (BMI \>30 kg/m2) with suspected CVD and scheduled for a cardiac CT examination (consisting of calcium scoring and coronary CT angiography).

You may qualify if:

• 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

You may not qualify if:

• Hospitalization for unstable angina pectoris or transient ischemic attack or due to congestive heart failure.
• Presently classified NYHA IV heart failure
• 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

Sponsors & Collaborators

• University Hospital, Bonn: lead
• European Union: collaborator

Study Sites (6)

Medical University Vienna

Vienna, 1090, Austria

NOT YET RECRUITING

University Hospital Leuven

Leuven, 3000, Belgium

NOT YET RECRUITING

University Hospital Pilsen

Pilsen, 323 00, Czechia

RECRUITING

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

University Hospital Mannheim

Mannheim, 68167, Germany

RECRUITING

University Hospital Zürich

Zurich, 8091, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulrike Attenberger, Prof. Dr.

  ulrike.attenberger@meduniwien.ac.at

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulrike Attenberger, Prof. Dr.

CONTACT

+43 (0)140400-48930; ulrike.attenberger@meduniwien.ac.at

Wiebke Fenske, Prof. Dr.

CONTACT

0234 302 6400; Wiebke.Fenske@bergmannsheil.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinic for Diagnostik and Interventional Radiology

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: September 19, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

BE (1); DE (2); CZ (1); AU (1); CH (1)