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临床试验/NCT06595134
NCT06595134招募中不适用

AI for the Prediction of Obesity-Related Vascular Diseases - Validation Study

University Hospital, Bonn6 个研究点 分布在 5 个国家目标入组 1,200 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,200
试验地点
6
主要终点
An improved accuracy in prediction of CVD progression by us-ing the AI-POD risk score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • 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

结局指标

主要结局

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

时间窗: Between Visit 1 and Visit 5 (Day 0 and Month 24)

Change in luminal stenosis

次要结局

  • 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)

研究者

发起方
University Hospital, Bonn
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Ulrike Attenberger

Director, Clinic for Diagnostik and Interventional Radiology

University Hospital, Bonn

研究点 (6)

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