Acute Cardiovascular DiseaseAI-PODNCT06595134
AI-POD Clinical Validation Study for Obese Patients
An observational study of Acute Cardiovascular Disease, run by University Hospital, Bonn at 6 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Acute Cardiovascular Disease
- What is being tested?
- Non Interventional
- How many people
- 1,200 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 1 Jul 2024to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
6 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 5 countries
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Bonn
Bonn, North Rhine-Westphalia, 53127
Ulrike Attenberger, Prof. Dr., 0228 287 15871, Ulrike.Attenberger@ukbonn.de
Wiebke Fenske, Prof. Dr., 0234 302 6400, Wiebke.Fenske@bergmannsheil.de
- Recruiting
University Hospital Mannheim
Mannheim, 68167
Stefan Schönberg, Prof. Dr., stefan.schoenberg@umm.de
Austria1 site, 1 recruiting
- Not yet recruiting
Medical University Vienna
Vienna, 1090
Christian Loewe, Prof. Dr., christian.loewe@meduniwien.ac.at
Belgium1 site, 1 recruiting
- Not yet recruiting
University Hospital Leuven
Leuven, 3000
Hilde Bosmans, Prof., hilde.bosmans@kuleuven.be
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Pilsen
Pilsen, 323 00
Jiri Ferda, Prof. Dr., ferda@fnplzen.cz
Switzerland1 site, 1 recruiting
- Not yet recruiting
University Hospital Zürich
Zurich, 8091
Hatem Alkadhi, Prof. Dr., hatem.alkadhi@usz.ch
About this study
Official title: AI for the Prediction of Obesity-Related Vascular Diseases - Validation Study
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.
Read the 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
- Being tested
- Non Interventional
- Keywords
- Obesity, Heart CT, Artificial Intelligence
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non InterventionalOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Standard Care plus Fitnesstracker and Citizen App Receives: Other: Non Interventional | |
| Arm 2 | Standard Care Receives: Other: Non Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
An improved accuracy in prediction of CVD progression by us-ing the AI-POD risk score
Change in plaque volume
Measured: 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
Measured: 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
Measured: 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
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
Measured: 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
Change in systolic blood pressure (mmHg)
Measured: 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
Change in diastolic blood pressure (mmHg)
Measured: 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
Change in pulse rate
Measured: 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
Change in body weight (Kgs)
Measured: 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
Change in fat mass (BIA); weight and height will be combined to report BMI in kg/m^2
Measured: 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
Change in waist circumference (cm)
Measured: 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
Change in HbA1c
Measured: 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
Change in total cholesterol, LDL, HDL, hsCRP, transaminases
Measured: 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
MACE (Major Adverse Cardiac Event)
Measured: After 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jul 2024
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Principal investigator, Prof. Dr. Ulrike Attenberger, University Hospital, Bonn
- Investigators
- Ulrike Attenberger, Prof. Dr., Principal investigator, ulrike.attenberger@meduniwien.ac.at
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595134
- Sponsor's protocol ID
- 310/23-EP
- Acronym
- AI-POD
- Status last verified
- Sep 2024
- First submitted
- 13 May 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI for the Prediction of Obesity-Related Vascular Diseases - Validation Study
- ClinicalTrials.gov ID
- NCT06595134
- Acronym / sponsor ID
- AI-POD / 310/23-EP
- Conditions
- Acute Cardiovascular Disease
- Keywords
- Obesity, Heart CT, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- European Union
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Other: Non InterventionalStandard Care plus Fitnesstracker and Citizen App |
| Arm 2 | – | Other: Non InterventionalStandard Care |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non InterventionalScreening (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) | Other | Arm 1, Arm 2 |
Primary outcome
An improved accuracy in prediction of CVD progression by us-ing the AI-POD risk score
Time frame: Between Visit 1 and Visit 5 (Day 0 and Month 24)
Change in plaque volume
An improved accuracy in prediction of CVD progression by us-ing the AI-POD risk score
Time frame: Between Visit 1 and Visit 5 (Day 0 and Month 24)
Change in plaque com-position/CAC
An improved accuracy in prediction of CVD progression by us-ing the AI-POD risk score
Time frame: Between Visit 1 and Visit 5 (Day 0 and Month 24)
Change in luminal stenosis
10 secondary outcomes
To validate the Citizen App, to assess the improvement of AI-POD risk score Accuracy and feasibility of collecting data with citizen App
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: After 2 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Cardiovascular Disease
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruiting
Effect of Early Tendon Vibrations on Upper Limb Motor Recovery After a Stroke
Acute Stroke, Upper Limb Motor Deficit
Not yet recruitingPhase 3
Metformin in Acute Ischemic Stroke
Acute Ischemic Stroke
Not yet recruiting
Safety of NRICM301 Added to Standard Care in Adults With Acute Ischemic Stroke
Acute Ischemic Stroke
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ulrike Attenberger, Prof. Dr. principal investigator
ulrike.attenberger@meduniwien.ac.at
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cardiovascular Disease, run by University Hospital, Bonn at 6 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Austria, Belgium, Czechia, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ulrike Attenberger, Prof. Dr. (+43 (0)140400-48930, ulrike.attenberger@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
An improved accuracy in prediction of CVD progression by us-ing the AI-POD risk score (time frame: Between Visit 1 and Visit 5 (Day 0 and Month 24)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.