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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Benjamin FERRAND
- 电话号码:+33 03.80.29.35.36
- 邮箱:benjamin.ferrand@chu-dijon.fr
学习地点
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Dijon、法国、21000
- 招聘中
- Chu Dijon Bourogne
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接触:
- Benjamin FERRAND
- 电话号码:+33 03.80.29.35.36
- 邮箱:benjamin.ferrand@chu-dijon.fr
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他: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. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Presence of an intracardiac thrombus (atrial or ventricular) detected by a contrast-enhanced CT scan performed within the first two months following enrollment
大体时间: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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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- GUENANCIA Astra Zeneca 2025
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研究美国 FDA 监管的设备产品
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