Deep Learning-Based Automated Pressure-Strain Loop Analysis
Noninvasive left ventricular pressure-strain loop analysis estimates myocardial work from longitudinal strain, brachial systolic blood pressure, and cardiac valve-event timing. It provides global work index, constructive work, wasted work, and work efficiency.
This study evaluates a deep-learning method that automates myocardial work and loop-shape analysis. The method may reduce analysis time, improve reproducibility, and identify patterns associated with heart failure.
調査の概要
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：Håvard Dalen, Professor Havard Dalen, MD, Ph
- 電話番号：+4772828027
- メール：havard.dalen@ntnu.no
研究場所
-
-
-
Trondheim、ノルウェー、7006
- St. Olavs hospital
-
コンタクト：
- Ingrid Yttervoll, MD
- 電話番号：90741665
- メール：ingrid.yttervoll@ntnu.no
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
Heart failure participants:
- Age ≥18 years
- Able to provide informed consent
- Previous myocardial infarction
- Left ventricular ejection fraction ≤40% after myocardial infarction
Healthy volunteers:
- Age ≥18 years
- Able to provide informed consent
Exclusion Criteria:
Heart failure participants:
- Unstable disease
- Contraindication to exercise testing or echocardiography, as judged by an experienced cardiologist
Healthy volunteers:
- Hypertension
- Diabetes mellitus
- Dyslipidemia
- Current smoking
- Pregnancy
- Significant systemic disease
- Cardioactive medication affecting heart rate, myocardial contractility, or vascular tone
- Echocardiographic findings suggesting structural heart disease
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：基礎科学
- 割り当て：非ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
実験的：Participants With Heart Failure
Participants undergo echocardiography at rest, during sustained handgrip, and during semi-supine bicycle exercise. |
Participants perform sustained isometric handgrip at around 30 % of maximal voluntary contraction for 5 minutes during echocardiography. Participants perform graded semi-supine bicycle exercise during echocardiography. |
|
実験的：Healthy Volunteers
Healthy volunteers undergo echocardiography at rest, during sustained handgrip, and during semi-supine bicycle exercise. |
Participants perform sustained isometric handgrip at around 30 % of maximal voluntary contraction for 5 minutes during echocardiography. Participants perform graded semi-supine bicycle exercise during echocardiography. |
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 |
|---|---|---|
|
Echocardiographic Acquisition Success
時間枠：During one study visit: at rest, during the handgrip and bicycle test.
|
Percentage of acquired examinations successfully processed by the deep-learning pipeline to generate myocardial work indices, assessed separately at rest, during handgrip, and during bicycle exercise. |
During one study visit: at rest, during the handgrip and bicycle test.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Agreement Between Deep Learning- and Expert-Derived Myocardial Work Indices
時間枠：Echocardiograms acquired at rest and during handgrip and bicycle exercise at a single study visit.
|
Agreement for myocardial work indices will be assessed using mean bias with 95% limits of agreement, and mean absolute error. |
Echocardiograms acquired at rest and during handgrip and bicycle exercise at a single study visit.
|
協力者と研究者
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
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?
IPD プランの説明
Individual participant data sharing is not currently planned. Any future sharing would require appropriate ethical, institutional, and data-protection approvals.
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
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。