Health TrialsbyHealthPanel

AI-POD Clinical Validation Study for Obese Patients

ConditionAcute Cardiovascular Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45+
SponsorUniversity Hospital, Bonn

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Non Interventional

    Other intervention

    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)

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: Arm 11 intervention
Group B: Arm 21 intervention

Trial outcomes

Primary outcomes

1

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

Change in plaque volume

Time frame
Between Visit 1 and Visit 5 (Day 0 and Month 24)
2

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

Change in plaque com-position/CAC

Time frame
Between Visit 1 and Visit 5 (Day 0 and Month 24)
3

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

Change in luminal stenosis

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

Secondary outcomes

1

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

Time-to-first occurrence of HbA1c greater than or equal to 48 mmol/mol (6.5%) for subjects with screening HbA1c \< 6.5 mmol/mol at study inclusion

Time frame
After 2 Years
2

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

Change in systolic blood pressure (mmHg)

Time frame
After 2 Years
3

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

Change in diastolic blood pressure (mmHg)

Time frame
After 2 Years
4

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

Change in pulse rate

Time frame
After 2 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Bonn

Lead sponsor

European Union

Collaborator

Source ClinicalTrials.gov
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