MitrAl Valve Calcium aSsEssmEnt With TrueVue Trans-illumination 3D Rendering. (MAC-SEE)
MitrAl Valve Calcium aSsEssmEnt With TrueVue Trans-illumination 3D Rendering (MAC SEE).
The study of calcifications involving the mitral valve is extremely important for the planning of both surgical and percutaneous procedures. Computed tomography (CT) is the non-invasive imaging modality considered the gold standard for the assessment of mitral valve calcifications, thanks to its high spatial resolution and the strong X-ray attenuation of calcium deposits.
Echocardiography has traditionally played a limited role in the evaluation of mitral valve calcifications, particularly with three-dimensional imaging. Three-dimensional transesophageal echocardiographic rendering with TrueVue transillumination (Philips Medical Systems, Eindhoven, NL) can provide additional information on the location and extent of calcium on the mitral valve by allowing the placement of a virtual light source beneath the mitral valve.
Specifically, the TrueVue system is an advanced software module integrated into Philips echographic equipment that uses data acquired by the transesophageal probe to generate photorealistic images of the heart.
Therefore, the ability to evaluate the position and extent of calcifications through transesophageal echocardiography may represent an important step forward for echocardiographic imaging.
調査の概要
詳細な説明
This is a non-profit, observational, bidirectional (prospective and retrospective), multicenter study aimed at comparing the diagnostic accuracy of the following modalities:
- Contrast-enhanced computed tomography (CT) (gold standard)
- Three-dimensional transesophageal echocardiography
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Gianluca Pontone, MD
- 電話番号：+39 0258002574
- メール：gianluca.pontone@cardiologicomonzino.it
研究場所
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Milan
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Milan、Milan、イタリア、20138
- 募集
- Centro Cardiologico Monzino; IRCCS
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コンタクト：
- Chiara Centenaro, 025800203
- 電話番号：+39 0258002031
- メール：chiara.centenaro@cardiologicomonzino.it
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria
Retrospective Cohort
- Have already undergone, between February 2025 and September 2025, a contrast-enhanced CT scan and a transesophageal echocardiogram.
- Are ≥ 18 years old.
Prospective Cohort
- Are scheduled to undergo a contrast-enhanced CT scan and a three-dimensional transesophageal echocardiogram as part of their routine clinical assessment for their underlying cardiac condition, with or without mitral annular or leaflet calcifications.
- Are ≥ 18 years old
- who have provided written informed consent to participate in the study
Exclusion Criteria:
Retrospective Cohort
- The following patients will be considered not eligible:
- Patients younger than 18 years.
- Patients whose data are incomplete for the purposes of the planned study assessments
- Patients who have explicitly refused the use of their data for research purposes.
Prospective Cohort
- Patients younger than 18 years.
- Patients who have not signed the study Informed Consent Form
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
コホートと介入
グループ/コホート |
|---|
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Prospective Cohort
In the prospective part of the study, adult patients who, for any clinical indication and as part of routine clinical care, are scheduled to undergo both contrast-enhanced chest computed tomography (CT) and three-dimensional transesophageal echocardiography (3D TEE) will be consecutively enrolled. As this is an observational study, participants will not undergo any additional diagnostic procedures or receive any additional treatments beyond standard clinical practice. Data will be collected from examinations performed according to routine care. |
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Retrospective Cohort
In the retrospective part of the study, clinical and imaging data will be collected from adult patients who have already undergone both contrast-enhanced chest computed tomography (CT) and three-dimensional transesophageal echocardiography (3D TEE) as part of routine clinical care. Eligible examinations performed between February 2025 and September 2025 will be reviewed. Only patients with complete data required for the study analyses will be included. No additional procedures or interventions will be performed, as the study is observational and based exclusively on existing clinical records. |
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 |
|---|---|---|
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Quantification of Mitral Calcifications
時間枠：06/2026
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Diagnostic accuracy in the quantification of mitral calcifications, assessed through qualitative visual evaluation and defined by the presence of calcium involving: (1) the mitral valve; (2) the mitral annulus, with or without differentiation of the mitral scallops; and (3) the mitral leaflets, with or without differentiation of the mitral scallops.
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06/2026
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Semiquantitative assessment of mitral calcifications
時間枠：06/2026
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Diagnostic accuracy in the semiquantitative assessment of mitral calcifications through calculation of the "Mitral Annular Calcification Score."
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06/2026
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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
- L2-438
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。