[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.
調査の概要
詳細な説明
[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.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Vicente Morales Oyarvide, MD, MPH
- 電話番号：6172335860
- メール：vmorales-oyarvide@bwh.harvard.edu
研究連絡先のバックアップ
- 名前：Sharmila Dorbala, MD, MPH
- 電話番号：617-732-6290
- メール：sdorbala@bwh.harvard.edu
研究場所
-
-
Massachusetts
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Boston、Massachusetts、アメリカ、02115
- 募集
- Brigham and Women's Hospital
-
コンタクト：
- Vicente Morales Oyarvide, MD, MPH
- 電話番号：6172335860
- メール：vmorales-oyarvide@bwh.harvard.edu
-
コンタクト：
- Sharmila Dorbala, MD, MPH
- 電話番号：617-732-6290
- メール：sdorbala@bwh.harvard.edu
-
主任研究者：
- Sharmila Dorbala, MD, MPH
-
副調査官：
- Vicente Morales Oyarvide, MD, MPH
-
副調査官：
- Ciprian Catana, MD
-
-
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:
- 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);
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：[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.
他の名前：
|
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 |
|---|---|---|
|
Intracardiac Thrombus
時間枠：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
|
1 day
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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
追加の関連 MeSH 用語
その他の研究ID番号
- 2025P003091
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