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临床试验/NCT06377319
NCT06377319尚未招募不适用

Clinical Validation of an Artificial Intelligence Based Decision Support System for Predicting Risk, Diagnosis, and Progression of Heart Failure

Coventry University0 个研究点目标入组 1,600 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,600
主要终点
Diagnostic accuracy of the DSS

研究概览

简要总结

Heart failure (HF) is a complex clinical syndrome associated with impaired heart function, poor quality of life for patients and high healthcare costs. Accurate risk stratification and early diagnosis in HF are challenging as signs and symptoms are non-specific. Here the investigators propose to address this global challenge by developing novel analytic methods for HF (STRATIFYHF). A prospective clinical study will collect patient-specific data related to medical history, a physical examination for signs and symptoms, blood tests including natriuretic peptides, an electrocardiogram (ECG), an echocardiogram (ultrasound of the heart), cardiovascular magnetic resonance imaging (MRI), demographic, socio-economic and lifestyle data along with novel technologies (cardiac output response to stress (CORS) test and voice recognition biomarkers) from individuals at-risk of developing HF and those with a confirmed diagnosis of HF. STRATIFYHF will use these data to develop, validate and implement the first artificial intelligence (AI)-based, Decision Support System (DSS) for assessing and predicting the risk of HF development, its early diagnosis and progression. STRATIFYHF will integrate 1) patient-specific data i.e. demographic, clinical, genetic, lifestyle and socio-economic, 2) an AI-based digital patient library and AI-driven algorithms for risk stratification, early diagnosis, and disease progression in HF, and 3) a highly innovative multifunctional AI-based DSS and mobile application for informing a patient-centred, personalised, prevention and treatment strategies for HF.

详细描述

Aim and Objectives:

This prospective study is part of the STRATIFYHF project which aims to validate a decision support system for risk prediction, diagnosis, and progression of HF.

To achieve this, the investigators will undertake a prospective study to collect data and deliver proof-of-concept study with a duration of 36 months.

Eight clinical centres will recruit 1,600 patients (i.e., 800 suspected and 800 confirmed HF patients) with recruitment target of 8-9 patients per month and up to 24-month follow-up.

Design and Methods:

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Diagnostic accuracy of the DSS

时间窗: 12 months

Collection of prospective data for the diagnostic accuracy (i.e., sensitivity and specificity) of the DSS to predict risk of developing HF within 12 months.

次要结局

  • Demographic and clinical predictors of risk, diagnosis, and progression of heart failure.(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Djordje Jakovljevic

Professor

Coventry University

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