跳至主要内容
临床试验/NCT05558605
NCT05558605招募中不适用

Use of Artificial Intelligence-Guided Echocardiography to assIst cardiovascuLar Patient managEment

Baker Heart and Diabetes Institute1 个研究点 分布在 1 个国家目标入组 612 人开始时间: 2023年2月24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
612
试验地点
1
主要终点
Diagnosis of cardiac dysfunction or heart valve disease

研究概览

简要总结

Heart Failure and valvular heart disease are disproportionate problems in rural and remote Australia (RRA). Echocardiography is the best imaging investigation, and essential for management, but access to this essential test shows huge geographic variations, primarily because of dependence on expert acquisition. This trial seeks to demonstrate the effectiveness of artificial intelligence-based echocardiography for triage and management of patients with known or suspected heart disease in RRA.

详细描述

Heart Failure (HF) and valvular heart disease (VHD) are disproportionate problems in rural and remote Australia (RRA) relative to the rest of the country, due in part to an ageing rural population and to the frequency of rheumatic heart disease in the Aboriginal community. Late diagnoses can lead to avoidable hospital admissions and expense to the Australian health system. Echocardiography is the imaging investigation of choice, and a cornerstone of management, but access to this essential test shows huge geographic variations in Australia. The primary reason for this is the dependence of this technique on expert acquisition. Artificial intelligence (AI) has now been harnessed to optimise echocardiographic image acquisition, and secure, cloud-based storage enables remote measurement and interpretation. This trial seeks to demonstrate the effectiveness of AI-based echocardiography-guided triage and management of patients with known or suspected heart disease in RRA. This study will involve the conduct of a world-first randomised controlled trial of AI-testing and early intervention to detect early stages of HF and VHD, select appropriate management, reduce admissions and preserve functional status and quality of life. The study will be conducted with partipants in RRA, aged 40 years and older with at least one HF risk factor and recruited through clinic and community outreach in four sites with the involvement of remote outreach from i) Alice Springs Hospitals, ii) Nepean Hospital to Dubbo Hospital and Western NSW, iii) Princess Alexandra Hospital to Roma, Charleville and Western Queensland, and iv) Perth Aboriginal communities in partnership with the Royal Perth hospital and the Derbarl Yerrigan Health Service. Approximately 1200 individuals at risk for HF and VHD will be screened and followed up. The study will be conducted in partnership with Aboriginal community partners.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

盲法说明

PROBE design

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 >45 years
  • eligible for Medicare
  • exercise intolerance or cardiovascular (CV) risk factors

排除标准

  • Known HF or HVD
  • situations where cardio-protection is already indicated (eg. known CAD)
  • comorbid conditions with life expectancy <2 years
  • inability to provide written informed consent

结局指标

主要结局

Diagnosis of cardiac dysfunction or heart valve disease

时间窗: 12 months

Number of Participants with Diagnosis of cardiac dysfunction or heart valve disease

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)

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