Accelerating Access and Improving Imaging in Heart Failure Care (A2I2HF) Pilot Study
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Clinical Trials Project Lead
- 電話番号：1-800-707-9098
- メール：aa2i2@ualberta.ca
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility of AI Assisted Point of Care Echocardiography Implementation
時間枠：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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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Diagnosis of heart failure (HF) within 90 days
時間枠：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).
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：During the enrollment period.
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During the enrollment period.
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Justin Ezekowitz, MD、University of Alberta
- 主任研究者：Safia Chatur, MD、Massachusetts General Hospital/Harvard Medical School and University of Alberta
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- A2I2HF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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