跳至主要内容
临床试验/NCT07648303
NCT07648303招募中不适用

Prevalence of Cardiac Thrombi in Cardiac Amyloidosis

Centre Hospitalier Universitaire Dijon2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年9月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
Presence of an intracardiac thrombus (atrial or ventricular) detected by a contrast-enhanced CT scan performed within the first two months following enrollment

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Individuals with intracardiac amyloidosis

Other

干预措施: Cardiac CT scan with contrast (Procedure)

结局指标

主要结局

Presence of an intracardiac thrombus (atrial or ventricular) detected by a contrast-enhanced CT scan performed within the first two months following enrollment

时间窗: During the first two months following enrollment

To determine the prevalence of intracardiac thrombi (atria and ventricles) diagnosed by contrast-enhanced cardiac CT in all patients treated for cardiac amyloidosis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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