跳至主要内容
临床试验/NCT05626413
NCT05626413招募中不适用

Cardiovascular Disease and Diabetes in Silesian Patients

Medical University of Silesia1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
4,000
试验地点
1
主要终点
The risk of cardiovascular disease and events among patients with diabetes

研究概览

简要总结

The project is an observational one which undertakes different, easy to obtain in everyday clinical practice, demographical, laboratory and clinical parameters of patients with diabetes in Silesian Region in Poland to predict cardiovascular disease, cardiovascular events and neuropathy using machine learning approach.

详细描述

The study is a prospective, observational one in which it is planned to obtain demographical, laboratory and clinical parameters of patients who are hospitalized in one the the main diabetology sites in Silesia region in Poland and to follow them prospectively for 10 years in order to collect information related to new cardiovascular events. Telephone contact will be performed every 12 months following hospital discharge. Any procedures related to the patients hospitalized in the diabetology ward will be the routine ones and the bioethics committee of Medical University of Silesia gave the permission for the study but waved the necessity of informed consent to be signed.Moreover there will be subgroup analysis of patients recruited from the outpatient diabetology clinics in Silesia region in order to participate in the observational study collecting data related to to vitamin D concentration, densitometry, fibroscan, carotid ultrasound examination, vascular stiffness, electrocardiography, peripheral and cardiovascular autonomic neuropathy and fundus imaging. Patients who are treated in outpatient diabetology clinics in Silesia region and are included into the study must have the informed consent signed and bioethics committee agreement has been obtained.

Machine learning approach will be implemented to discover the association between easy to obtain in everyday practice parameters, namely clinical, biochemical, and demographical ones to identify patients at the highest risk of cardiovascular disease.

The secondary aim of the study is to utilize fundus imaging, electrocardiography, alongside demographic and clinical data in order to potentially diagnose neuropathy.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For the group of hospitalized patients: diabetes type 1 or type 2
  • For the subgroup of patients treated in outpatient diabetology clinics in Silesia region: diabetes type 1 or type 2

排除标准

  • For the group of hospitalized patients:
  • Types of diabetes other than type 1 and type 2 diabetes
  • Death during hospital stay
  • Terminal stage of cancer.
  • For the subgroup of patients recruited form outpatient diabetology clinics:
  • Lack of an informed consent
  • Types of diabetes other than type 1 and type 2 diabetes
  • Malignant neoplasms
  • Terminal stage of neoplasm
  • End-stage renal disease
  • Malabsorption syndrome
  • Active infection
  • Primary hyperparathyroidism

结局指标

主要结局

The risk of cardiovascular disease and events among patients with diabetes

时间窗: 5 years

To predict the risk of cardiovascular disease and events among patients with diabetes using machine learning approach

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Cardiovascular Disease in Patients With Diabetes:... | 临床试验