[64Cu]FBP8 PET for Early Detection of Intracardiac Thrombus in Amyloid Cardiomyopathy
The primary goal of this pilot study is to determine whether [64Cu]FBP8, a novel fibrin-binding positron emission tomography (PET) probe, can identify intracardiac thrombi when paired with simultaneous hybrid cardiac PET/MRI in twenty (20) individuals with transthyretin or light chain cardiac amyloidosis and atrial fibrillation (AF) or atrial flutter (AF).
The primary hypothesis of this study is that [64Cu]FBP8 PET/MRI can identify intracardiac thrombi in >90% of subjects with confirmed intracardiac thrombi based on transesophageal echocardiogram (TEE). In secondary analyses, the investigators will seek to determine associations between intracardiac thrombi and left atrial function and left ventricular amyloid burden.
研究概览
详细说明
[64Cu]FBP8 is a novel copper-64 labeled molecular imaging probe that selectively binds to fibrin, the main constituent of human thrombi. In animal models, [64Cu]FBP8 has been shown to effectively detect pulmonary emboli, deep venous thromboses, and intracardiac thrombi. In a first-in-human study, [64Cu]FBP8 paired with simultaneous cardiac positron emission tomography (PET) and magnetic resonance imaging (MRI) accurately detected intracardiac thrombi (specifically, left atrial appendage [LAA] thrombi) in patients with atrial fibrillation (AF) with an accuracy of >90% using transesophageal echocardiogram (TEE) as the reference standard. The investigators propose to study the value of [64Cu]FBP8 PET/MRI to detect intracardiac thrombi in patients with cardiac amyloidosis.
This pilot study is designed to assess the value of [64Cu]FBP8 PET/MRI to detect intracardiac thrombi in twenty (20) patients with cardiac amyloidosis and atrial fibrillation (AF) or atrial flutter (AFL) compared to TEE. The primary hypothesis is that [64Cu]FBP8 PET/MRI can identify intracardiac thrombi in >90% of subjects with confirmed intracardiac thrombi based on TEE. In secondary analyses, the investigators will seek to determine associations between intracardiac thrombi and left atrial function and left ventricular amyloid burden.
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Vicente Morales Oyarvide, MD, MPH
- 电话号码：6172335860
- 邮箱：vmorales-oyarvide@bwh.harvard.edu
研究联系人备份
- 姓名：Sharmila Dorbala, MD, MPH
- 电话号码：617-732-6290
- 邮箱：sdorbala@bwh.harvard.edu
学习地点
-
-
Massachusetts
-
Boston、Massachusetts、美国、02115
- 招聘中
- Brigham and Women's Hospital
-
接触：
- Vicente Morales Oyarvide, MD, MPH
- 电话号码：6172335860
- 邮箱：vmorales-oyarvide@bwh.harvard.edu
-
接触：
- Sharmila Dorbala, MD, MPH
- 电话号码：617-732-6290
- 邮箱：sdorbala@bwh.harvard.edu
-
首席研究员：
- Sharmila Dorbala, MD, MPH
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副研究员：
- Vicente Morales Oyarvide, MD, MPH
-
副研究员：
- Ciprian Catana, MD
-
-
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:
- Have the ability to give written informed consent;
- History of amyloid cardiomyopathy (ATTR-CM or AL-CM);
- History of AF or AFL;
- Retrospective enrollment: TEE to evaluate LAA within the previous 14 days, provided the anticoagulation regimen the patient is on is not changed after the TEE. If a patient has a negative TEE and continues the same stable anticoagulation regimen, then it is unlikely that a new thrombus will develop in the LAA within the next 14 days. Likewise, if a patient not taking any anticoagulation has a thrombus in the LAA, then it is unlikely that this thrombus will resolve spontaneously in the next 14 days if the patient remains off anticoagulation. If the TEE leads to a change being made in the anticoagulation regimen (started/stopped/dose modified), then a time window of 72 hours from the TEE to PET/MR imaging will be used. This scheme will ensure that the TEE can serve as an accurate gold standard;
- Prospective: TEE to evaluate LAA thrombus scheduled in upcoming 14 days;
Exclusion Criteria:
- Electrical implants such as cardiac pacemaker/defibrillator, perfusion pump, direct brain stimulator;
- Pregnancy or breastfeeding (a negative quantitative serum or urine hCG pregnancy test is required for females having child-bearing potential before the subject can participate);
- Claustrophobia;
- Subjects will be excluded if research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);
- Unable to lie comfortably on a bed inside the PET/MR scanner;
- Subjects under direct or indirect (i.e., same department as PIs) supervision of the principal investigator;
- Body weight over the weight limit for the moving table (> 300 lbs for the MR table);
- Metallic or electric implants contraindicated for PET/MR scanning;
- Stroke, myocardial infarction, cardiac or major surgery within the last 3 months;
- History of LAA ligation/exclusion or presence of a LAA occlusion device;
- History of syncope within the last 6 weeks;
- Heart rate persistently >120 bpm or persistently <50 bpm;
- Daytime pauses >3 seconds;
- Lack of a prior transthoracic echocardiogram within the previous 6 months;
- Does not have the ability to give written informed consent;
- Determined by the investigator(s) to be clinically unsuitable for the study (e.g., based on screening visit and/or during study procedures);
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：[64Cu]FBP8 PET/MR Cardiac Amyloid and Atrial Fibrillation/Atrial Flutter Subjects
Individuals with documented cardiac amyloidosis and atrial fibrillation/atrial flutter will undergo [64Cu]FBP8 PET/MR.
|
Simultaneous cardiac PET/MR images will be obtained following injection of [64Cu]FBP8.
其他名称：
|
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 |
|---|---|---|
|
Intracardiac Thrombus
大体时间：1 day
|
Presence or absence of intracardiac thrombus based on [64Cu]FBP8 PET/MR imaging, as determined by standardized uptake values (SUV), and transesophageal echocardiogram
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1 day
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合作者和调查者
出版物和有用的链接
一般刊物
- Izquierdo-Garcia D, Desogere P, Philip AL, Mekkaoui C, Weiner RB, Catalano OA, Iris Chen YC, DeFaria Yeh D, Mansour M, Catana C, Caravan P, Sosnovik DE. Detection and Characterization of Thrombosis in Humans Using Fibrin-Targeted Positron Emission Tomography and Magnetic Resonance. JACC Cardiovasc Imaging. 2022 Mar;15(3):504-515. doi: 10.1016/j.jcmg.2021.08.009. Epub 2021 Oct 13.
- Vilches S, Fontana M, Gonzalez-Lopez E, Mitrani L, Saturi G, Renju M, Griffin JM, Caponetti A, Gnanasampanthan S, De Los Santos J, Gagliardi C, Rivas A, Dominguez F, Longhi S, Rapezzi C, Maurer MS, Gillmore J, Garcia-Pavia P. Systemic embolism in amyloid transthyretin cardiomyopathy. Eur J Heart Fail. 2022 Aug;24(8):1387-1396. doi: 10.1002/ejhf.2566. Epub 2022 Jul 11.
- Donnellan E, Hussain M, Marrouche N, Park M, Martin M, Hanna M, Wazni O, Collier P, Jaber W. Left Atrial Strain May Predict Thrombus Formation in Patients With Transthyretin Cardiac Amyloidosis. JACC Clin Electrophysiol. 2023 Aug;9(8 Pt 1):1418-1420. doi: 10.1016/j.jacep.2023.03.013. Epub 2023 May 24. No abstract available.
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
- 2025P003091
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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