Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-01-08 @ 6:48 AM
Study NCT ID:
NCT06595134
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AI-POD Clinical Validation Study for Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-10', 'studyFirstSubmitDate': '2024-05-13', 'studyFirstSubmitQcDate': '2024-09-10', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'An improved accuracy in prediction of CVD progression by us-ing the AI-POD risk score', 'timeFrame': 'Between Visit 1 and Visit 5 (Day 0 and Month 24)', 'description': 'Change in plaque volume'}, {'measure': 'An improved accuracy in prediction of CVD progression by us-ing the AI-POD risk score', 'timeFrame': 'Between Visit 1 and Visit 5 (Day 0 and Month 24)', 'description': 'Change in plaque com-position/CAC'}, {'measure': 'An improved accuracy in prediction of CVD progression by us-ing the AI-POD risk score', 'timeFrame': 'Between Visit 1 and Visit 5 (Day 0 and Month 24)', 'description': 'Change in luminal stenosis'}], 'secondaryOutcomes': [{'measure': 'To validate the Citizen App, to assess the improvement of AI-POD risk score Accuracy and feasibility of collecting data with citizen App', 'timeFrame': 'After 2 Years', 'description': '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'}, {'measure': 'To validate the Citizen App, to assess the improvement of AI-POD risk score Accuracy and feasibility of collecting data with citizen App', 'timeFrame': 'After 2 Years', 'description': 'Change in systolic blood pressure (mmHg)'}, {'measure': 'To validate the Citizen App, to assess the improvement of AI-POD risk score Accuracy and feasibility of collecting data with citizen App', 'timeFrame': 'After 2 Years', 'description': 'Change in diastolic blood pressure (mmHg)'}, {'measure': 'To validate the Citizen App, to assess the improvement of AI-POD risk score Accuracy and feasibility of collecting data with citizen App', 'timeFrame': 'After 2 Years', 'description': 'Change in pulse rate'}, {'measure': 'To validate the Citizen App, to assess the improvement of AI-POD risk score Accuracy and feasibility of collecting data with citizen App', 'timeFrame': 'After 2 Years', 'description': 'Change in body weight (Kgs)'}, {'measure': 'To validate the Citizen App, to assess the improvement of AI-POD risk score Accuracy and feasibility of collecting data with citizen App', 'timeFrame': 'After 2 Years', 'description': 'Change in fat mass (BIA); weight and height will be combined to report BMI in kg/m\\^2'}, {'measure': 'To validate the Citizen App, to assess the improvement of AI-POD risk score Accuracy and feasibility of collecting data with citizen App', 'timeFrame': 'After 2 Years', 'description': 'Change in waist circumference (cm)'}, {'measure': 'To validate the Citizen App, to assess the improvement of AI-POD risk score Accuracy and feasibility of collecting data with citizen App', 'timeFrame': 'After 2 Years', 'description': 'Change in HbA1c'}, {'measure': 'To validate the Citizen App, to assess the improvement of AI-POD risk score Accuracy and feasibility of collecting data with citizen App', 'timeFrame': 'After 2 Years', 'description': 'Change in total cholesterol, LDL, HDL, hsCRP, transaminases'}, {'measure': 'To validate the Citizen App, to assess the improvement of AI-POD risk score Accuracy and feasibility of collecting data with citizen App', 'timeFrame': 'After 2 Years', 'description': 'MACE (Major Adverse Cardiac Event)'}]}, 'conditionsModule': {'keywords': ['Obesity, Heart CT, Artificial Intelligence'], 'conditions': ['Acute Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Obese patients (BMI \\>30 kg/m2) with suspected CVD and scheduled for a cardiac CT examination (consisting of calcium scoring and coronary CT angiography).', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 45 years at the time of signing informed consent\n* BMI greater than or equal to 30 kg/m2\n* Patients with suspected CVD (\\>15% pretest probability \\[ESC guidelines\\]), referred for cardiac CT examinations (consisting of coronary calcium scoring and coronary CT angiography)\n* Informed consent of the patient\n\nExclusion Criteria:\n\n* Any of the following CV conditions within 2 months prior to study inclusion: myocardial infarction, stroke,\n* Hospitalization for unstable angina pectoris or transient ischemic attack or due to congestive heart failure.\n* Planned coronary, carotid, or peripheral artery revascularisation known on the day of inclusion\n* Presently classified NYHA IV heart failure\n* Having uncontrolled diabetes mellitus (HbA1c ≥ 11%) at day of inclusion\n* Having uncontrolled hypertension (SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg) as measured at inclusion\n* Having severe renal impairment measured as an eGFR \\< 30 mL/min/1.73 m2 at inclusion\n* Alanine aminotransferase (ALT) or alkaline phosphatase (APT) level \\< 3.0 x the upper limit of normal (ULN)for the reference range\n* Total bilirubin level \\>1.5 x the ULN for the reference range\n* History of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years\n* Previous organ transplantation or awaiting an organ transplant\n* Pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT06595134', 'acronym': 'AI-POD', 'briefTitle': 'AI-POD Clinical Validation Study for Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bonn'}, 'officialTitle': 'AI for the Prediction of Obesity-Related Vascular Diseases - Validation Study', 'orgStudyIdInfo': {'id': '310/23-EP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm 1', 'description': 'Standard Care plus Fitnesstracker and Citizen App', 'interventionNames': ['Other: Non Interventional']}, {'label': 'Arm 2', 'description': 'Standard Care', 'interventionNames': ['Other: Non Interventional']}], 'interventions': [{'name': 'Non Interventional', 'type': 'OTHER', 'description': '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)', 'armGroupLabels': ['Arm 1', 'Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'NOT_YET_RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christian Loewe, Prof. Dr.', 'role': 'CONTACT', 'email': 'christian.loewe@meduniwien.ac.at'}], 'facility': 'Medical University Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '3000', 'city': 'Leuven', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Hilde Bosmans, Prof.', 'role': 'CONTACT', 'email': 'hilde.bosmans@kuleuven.be'}], 'facility': 'University Hospital Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '323 00', 'city': 'Pilsen', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Jiri Ferda, Prof. Dr.', 'role': 'CONTACT', 'email': 'ferda@fnplzen.cz'}], 'facility': 'University Hospital Pilsen', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'zip': '53127', 'city': 'Bonn', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ulrike Attenberger, Prof. Dr.', 'role': 'CONTACT', 'email': 'Ulrike.Attenberger@ukbonn.de', 'phone': '0228 287 15871'}, {'name': 'Wiebke Fenske, Prof. Dr.', 'role': 'CONTACT', 'email': 'Wiebke.Fenske@bergmannsheil.de', 'phone': '0234 302 6400'}], 'facility': 'University Hospital Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '68167', 'city': 'Mannheim', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stefan Schönberg, Prof. Dr.', 'role': 'CONTACT', 'email': 'stefan.schoenberg@umm.de'}], 'facility': 'University Hospital Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '8091', 'city': 'Zurich', 'status': 'NOT_YET_RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Hatem Alkadhi, Prof. Dr.', 'role': 'CONTACT', 'email': 'hatem.alkadhi@usz.ch'}], 'facility': 'University Hospital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Ulrike Attenberger, Prof. Dr.', 'role': 'CONTACT', 'email': 'ulrike.attenberger@meduniwien.ac.at', 'phone': '+43 (0)140400-48930'}, {'name': 'Wiebke Fenske, Prof. Dr.', 'role': 'CONTACT', 'email': 'Wiebke.Fenske@bergmannsheil.de', 'phone': '0234 302 6400'}], 'overallOfficials': [{'name': 'Ulrike Attenberger, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ulrike.attenberger@meduniwien.ac.at'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bonn', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Union', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Clinic for Diagnostik and Interventional Radiology', 'investigatorFullName': 'Prof. Dr. Ulrike Attenberger', 'investigatorAffiliation': 'University Hospital, Bonn'}}}}