Accelerating Access and Improving Imaging in Heart Failure Care (A2I2HF) Pilot Study
研究概览
详细说明
Heart failure remains underdiagnosed in frontline care settings, in part due to limited access to timely echocardiography. Recent advances in artificial intelligence (AI)-assisted echocardiography may facilitate scalable bedside screening through automated image acquisition support and interpretation.
This is a prospective, multicenter, cluster randomised trial which will assess the feasibility and acceptability of routine implementation of AI-assisted point of care echocardiography on HF detection and downstream processes of care for patients with suspected HF being discharged from the Emergency Department.
This study will be carried out at 2 participating Emergency Departments (EDs) in Alberta, Canada. Each ED site will alternate monthly between Intervention (AI-assisted echocardiography) and Control (Usual Care) periods.
During intervention periods, patients with suspected HF will undergo AI-assisted echocardiography using a handheld point of care EchoNous Kosmos device by the treating ED physician. The US2.ai algorithm will generate an AI-automated echo report. During control periods, patients will be managed according to usual care.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Clinical Trials Project Lead
- 电话号码：1-800-707-9098
- 邮箱：aa2i2@ualberta.ca
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Adult patients age ≥18 years presenting to the ED;
- with signs or symptoms of HF as per the treating physician and
elevated natriuretic peptides (NT-proBNP>125pg/mL or BNP>50pg/mL); drawn as part of standard of care of evaluation in the ED, OR age≥ 40 years and ≥1 HF risk factor:
- Established diagnosis of type 2 diabetes
- Coronary artery disease (prior documented type 1 myocardial infarction or coronary artery bypass grafting or percutaneous coronary intervention or documented stenosis of an epicardial coronary artery (>50% left main or >70% left anterior descending, circumflex or right coronary artery)
- Previous ischemic or embolic stroke
- Peripheral artery disease (previous surgical or percutaneous revascularization or a documented stenosis greater than 50% of a major peripheral arterial vessel).
- Regular loop diuretic use
Exclusion Criteria:
- prior documented diagnosis of HF;
- any patient receiving renal replacement therapy;
- any patient receiving comfort or palliative care;
- pregnant or nursing patients;
- patients planned for admission
- Investigator/treating physician discretion: any patient not suitable for participation for other reasons
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：顺序分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Intervention
During each month-long Intervention period, an AI-assisted POCUS tool will be available for ED physicians use, at their discretion, to assess left ventricular ejection fraction (LVEF) and diastolic function in patients presenting to the ED with suspected HF.
The AI-automated echocardiogram report may be used in the referral pathway to the HF clinic if deemed clinically appropriate.
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ED physicians at both sites will be provided with 1 session of in person training in the use of the AI-assisted POCUS device within 4 weeks of randomization including,
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无干预：Control Period (Usual Care)
During each month-long Control period, the ED physicians will manage patients as close to "true" usual care as possible.
There is no "placebo" arm.
No actions will be undertaken to impede or prohibit care in the usual care arm.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Feasibility of AI Assisted Point of Care Echocardiography Implementation
大体时间：During the enrollment period.
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Proportion of eligible patients successfully undergoing AI assisted echo assessment at the point of care.
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During the enrollment period.
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Diagnosis of heart failure (HF) within 90 days
大体时间：At 90 days.
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At 90 days.
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Downstream health care resource utilization at 90 days and 1 year (e.g. rates of requests for echocardiography, cardiology referral, primary care appointments, HF hospitalization).
大体时间：At 90 days and 1 year.
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At 90 days and 1 year.
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Proportion of patients with HF receiving GDMT within 90 days
大体时间：At 90 days.
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At 90 days.
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Difference in ratio of the incidence of diagnoses of HF via hospital admission-based versus community-based pathways
大体时间：At 90 days.
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At 90 days.
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Uptake and utilization: differential rates of uptake and utilization of AI Assisted echocardiography in the emergency department
大体时间：During the enrollment period.
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During the enrollment period.
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Determinants of uptake and utilization of AI assisted echocardiography in the emergency department (clinician questionnaire)
大体时间：During the enrollment period.
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During the enrollment period.
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合作者和调查者
调查人员
- 首席研究员：Justin Ezekowitz, MD、University of Alberta
- 首席研究员：Safia Chatur, MD、Massachusetts General Hospital/Harvard Medical School and University of Alberta
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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