Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595134
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-13
Brief Title:
AI-POD Clinical Validation Study for Obese Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
AI for the Prediction of Obesity-Related Vascular Diseases - Validation Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AI-POD
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 kgm2 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 GOTALAT GPTASAT 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: