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Capitalizing on AI to CapTure Undiagnosed Structural Heart Disease (CACTUS)

2026年9月21日 更新者:Pierre Elias

Doctors are testing a new tool called EchoNext to see if it can help find heart problems earlier. EchoNext looks at the heart's electrical test, called an ECG, and uses artificial intelligence (AI) to check for signs of structural heart disease (SHD). SHD includes conditions like weak heart pumping, heart valve problems, or extra thickening of the heart muscle. These problems are common but often go undiagnosed until they cause serious issues like heart failure or stroke.

The main questions this study will answer are:

Can EchoNext alerts help emergency doctors find hidden heart problems sooner?

Does this lead to more follow-up heart tests, like an echocardiogram (heart ultrasound)?

What this means for patients: If a person has an ECG in the Emergency Department, the EchoNext tool may be used to check their heart. If the tool finds something unusual, their doctor may receive an alert and may then recommend further heart tests or follow-up care.

This study will help researchers learn if using EchoNext improves early diagnosis and treatment of heart disease.

調査の概要

詳細な説明

Structural heart disease (SHD) is a major cause of illness and death, especially in older adults. SHD includes conditions such as valvular heart disease (e.g., aortic stenosis, mitral regurgitation), left or right ventricular dysfunction, left ventricular hypertrophy, pulmonary artery hypertension, and pericardial effusions. These conditions are often underdiagnosed, and delayed recognition can lead to complications such as heart failure, stroke, and cardiomyopathy. Early detection and treatment can improve outcomes, but current approaches often miss patients in the early stages of disease.

EchoNext is an artificial intelligence model trained on over 400,000 ECG-echocardiogram pairs. It analyzes the standard 12-lead ECG to predict the presence of structural heart disease, as defined by echocardiographic findings. The model has demonstrated strong diagnostic performance, with an area under the receiver operating characteristic (AUROC) curve of 0.86 across diverse populations.

The purpose of this trial is to evaluate whether deploying EchoNext into the Emergency Department (ED) electronic health record (EHR) as a clinical decision support alert can increase the detection of undiagnosed SHD. The ED setting is ideal because: (1) ECGs are widely obtained for many presenting complaints, (2) abnormal ECG findings related to SHD are often overlooked in the acute setting, and (3) EDs provide access to disadvantaged populations and a unique opportunity to deliver population-level interventions.

In this study, ECGs obtained in the ED will be analyzed in real time by the EchoNext model. If the model predicts moderate or severe SHD, an EHR alert will be displayed to the treating provider (attending physician, fellow, resident, physician assistant, or nurse practitioner). The alert will inform providers of the potential for underlying SHD and recommend consideration of follow-up echocardiography or specialty referral. Outcomes will include rates of new SHD diagnoses confirmed by echocardiography, follow-up testing and referrals, and downstream patient outcomes.

The Community Tele-Paramedicine (CTP) program, an established post-discharge care initiative at NewYork-Presbyterian, will also serve as a follow-up resource for patients identified in the ED. CTP combines home visits by community paramedics, telehealth visits by emergency physicians, and nurse care management to coordinate outpatient testing and follow-up care. Integration with CTP will facilitate timely echocardiography and referral for patients flagged by EchoNext, particularly for high-risk or underserved populations.

This trial will determine whether AI-driven ECG interpretation can improve early detection of SHD and lead to better patient outcomes compared to standard care.

研究の種類

介入

入学 (推定)

4000

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • New York
      • New York、New York、アメリカ、10032
        • 募集
        • Columbia University Irving Medical Center / NewYork-Presbyterian
        • コンタクト:
        • 主任研究者:
          • Pierre Elias, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

40年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • 40 years of age or older
  • Received an ECG upon presentation to the Emergency Department

Exclusion Criteria:

  • Had an echocardiogram within the prior 2 years.
  • Has a history of structural heart disease.
  • Not able to receive follow-up based on Community Tele-Paramedicine care manager review.
  • Quality of life will not improve over the next five years.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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:ふるい分け
  • 割り当て:ランダム化
  • 介入モデル:クロスオーバー割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
介入なし:Standard Treatment - No EHR Alert

Emergency department providers will not be alerted in the electronic health record (EHR) if a patient's electrocardiogram (ECG) ordered in the ED is identified by the EchoNext algorithm as suggesting structural heart disease (SHD) and potentially benefit from an echocardiogram.

実験的:Intervention - EHR Alert & Community Tele-paramedicine

Emergency department providers will be alerted in the electronic health record (EHR) if a patient's electrocardiogram (ECG) ordered in the ED is identified by the EchoNext algorithm as suggesting structural heart disease (SHD) and potentially benefit from an echocardiogram. These patients will also be referred to Community Tele-paramedicine for follow-up for potential echocardiogram.

EKG Algorithm to identify structural heart disease

他の名前:
  • EchoNext

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
Number of new diagnoses of Structural Heart Disease (SHD)
時間枠:180 days post index ED visit

Number of patients with a new diagnosis of structural heart disease (SHD), including moderate or greater valvular disease, left or right ventricular systolic dysfunction, left ventricular hypertrophy, pulmonary artery hypertension, or moderate/large pericardial effusions, confirmed by echocardiography or other clinical evaluation.

180 days post index ED visit

二次結果の測定

結果測定
メジャーの説明
時間枠
Rate of echocardiography ordering
時間枠:180 days post index ED visit

Proportion of patients who received an echocardiogram following the index ED visit.

180 days post index ED visit
New Medical Treatments for SHD
時間枠:180 days post index ED visit

Number of patients initiating new cardiovascular medications (e.g., antihypertensives, diuretics) specifically for treatment of structural heart disease.

180 days post index ED visit
New Surgical or Procedural Interventions for SHD
時間枠:180 days post-index ED visit

Number of patients undergoing procedural interventions for SHD, including valve repair/replacement, cardiac surgery, drainage of pericardial effusion, or implanted defibrillator placement.

180 days post-index ED visit
Long-Term Medical Treatments for SHD
時間枠:1 year post-index ED visit

Number of patients who initiated new cardiovascular medications (e.g., antihypertensives, diuretics) for treatment of structural heart disease within 1 year.

1 year post-index ED visit

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Pierre Elias, MD、Columbia University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年9月16日

一次修了 (推定)

2027年6月1日

研究の完了 (推定)

2028年6月1日

試験登録日

最初に提出

2026年9月21日

QC基準を満たした最初の提出物

2026年9月21日

最初の投稿 (実際)

2026年9月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月25日

QC基準を満たした最後の更新が送信されました

2026年9月21日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Individual participant data (IPD) from this study will not be shared. The data contain protected health information (PHI) from electronic health records (EHR) and are linked to specific patients and providers. Sharing this information could risk patient privacy and confidentiality, even with de-identification. Additionally, the data are collected under institutional policies and HIPAA regulations that restrict external access.

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

いいえ

米国FDA規制機器製品の研究

はい

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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