Prevalence of Cardiac Thrombi in Cardiac Amyloidosis (CATICA)
Cardiac amyloidosis (CA) is an infiltrative disease characterized by deposits of amyloid proteins of genetic or acquired origin (often in elderly patients), leading to heart failure and arrhythmias. More than 98% of currently diagnosed cases of cardiac amyloidosis result from fibrils composed of monoclonal immunoglobulin light chains (AL) or transthyretin (ATTR), in its hereditary (ATTRv) or acquired (ATTRwt) form.
Its prevalence is rising sharply due to an aging population and improved diagnostic techniques. Atrial fibrillation is responsible, in particular, for heart failure, arrhythmias, conduction disorders, and ischemic strokes, and is associated with significant morbidity and mortality. These patients have a much higher-than-normal risk of stroke because they are in a procoagulant state in the left atrium, even in the absence of atrial fibrillation. Intracardiac thrombi (ICTs) are present in 28% of patients with AC requiring cardioversion, compared with 2.5% of patients without AC, 50% of whom are on anticoagulants.
It has also been shown that the CHA2DS2-VASc score is not effective in predicting thromboembolic risk, and that direct oral anticoagulants (DOACs) are as effective as vitamin K antagonists (VKAs) in preventing embolisms.
The prevalence and factors associated with the development of intracardiac thrombi in patients with cardiac amyloidosis are unknown, as the available retrospective studies focused only on selected high-risk patients. Furthermore, tafamidis is now available to stabilize the course of cardiac amyloidosis and improve prognosis, but its effect on thromboembolic risk remains unknown.
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:Benjamin FERRAND
- 電話番号:+33 03.80.29.35.36
- メール:benjamin.ferrand@chu-dijon.fr
研究場所
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Dijon、フランス、21000
- Chu Dijon Bourogne
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コンタクト:
- Benjamin FERRAND
- 電話番号:+33 03.80.29.35.36
- メール:benjamin.ferrand@chu-dijon.fr
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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
説明
Inclusion Criteria:
- Individuals with a diagnosis of cardiac amyloidosis (AL diagnosed by echocardiography and/or MRI combined with histological evidence; or ATTR diagnosed in the presence of typical cardiac abnormalities on echocardiography and/or MRI with cardiac hyperintensity)
- Individuals who have had at least one consultation related to their cardiac amyloidosis at the Dijon University Hospital during the year prior to enrollment
- Adults
Exclusion Criteria:
- Individuals with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m²
- Anyone with a known allergy to iodinated contrast agents
- Overt thyrotoxicosis
- Uncontrolled asthma
- Individuals with a known history of cardiac thrombus
- Individuals with a history of percutaneous or surgical closure of the left atrial appendage
- Individuals not enrolled in or not eligible for a social security program
- Individuals under legal guardianship
- Individuals under conservatorship
- Pregnant or breastfeeding women
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:なし
- 介入モデル:単一グループの割り当て
- 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 |
|---|---|
|
他の:Individuals with intracardiac amyloidosis
|
A peripheral venous line will be inserted by the radiology technicians prior to the exam and removed at the end of the exam. Cardiac CT scan with Iomeron 400 injection, ECG synchronization and automatic spiral acquisition. Analysis of total cardiac mass. Post-processing using ADAS 3D Galgo and Syngovia software: detection of intracardiac thrombi, assessment of extracellular volume, measurement of atrial and ventricular volumes and epicardial fat. |
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 |
|---|---|---|
|
Presence of an intracardiac thrombus (atrial or ventricular) detected by a contrast-enhanced CT scan performed within the first two months following enrollment
時間枠:During the first two months following enrollment
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To determine the prevalence of intracardiac thrombi (atria and ventricles) diagnosed by contrast-enhanced cardiac CT in all patients treated for cardiac amyloidosis
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During the first two months following enrollment
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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 (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
追加の関連 MeSH 用語
その他の研究ID番号
- GUENANCIA Astra Zeneca 2025
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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