Left Atrial Strain May Predict Thrombus Formation in Patients With Transthyretin Cardiac Amyloidosis.
Eoin Donnellan, Muzna Hussain, Nassir Marrouche...
https://pubmed.ncbi.nlm.nih.gov/37227355/Actively Recruiting
Led by Brigham and Women's Hospital · Updated on 2026-07-21
20
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating a new imaging technique using 64CuFBP8, a novel fibrin-binding PET probe combined with simultaneous cardiac PETMRI, to detect intracardiac blood clots in people with transthyretin or light chain cardiac amyloidosis who also have atrial fibrillation or atrial flutter. This pilot study aims to see if the imaging can identify clots in over 90% of patients who have confirmed clots based on a standard transesophageal echocardiogram TEE. Secondary analyses will explore how these clots relate to heart function and amyloid build-up in the left ventricle. Participants will receive an injection of 64CuFBP8 followed by simultaneous cardiac PETMR imaging. The study involves twenty individuals with documented cardiac amyloidosis and atrial fibrillation or flutter. The imaging is performed once, and results will be compared to recent or upcoming TEE tests to confirm the presence of clots. This study focuses on evaluating the diagnostic value of this new PETMRI method in detecting intracardiac thrombi. During the study, participants will undergo PETMR imaging after receiving the tracer injection. The main outcome measured is the detection of intracardiac thrombus within one day of imaging. The researchers will also assess associations between clots and heart function or amyloid burden. Participants will be monitored for eligibility and safety, including assessments of their ability to undergo imaging and recent heart evaluations. The study is expected to last from July 2026 to March 2027, with diagnostic imaging as the key procedure.
CONDITIONS
[64Cu]FBP8 PET for Early Detection of Intracardiac Thrombus in Amyloid Cardiomyopathy
V
Vicente Morales Oyarvide, MD, MPH
S
Sharmila Dorbala, MD, MPH
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Brigham and Women's Hospital
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | [64Cu]FBP8 PET/MR Imaging | TEE (Current Reference Standard) |
|---|---|---|
| What it is | [64Cu]FBP8 PET/MR is a simultaneous positron emission tomography and magnetic resonance imaging scan performed after injection of the fibrin-targeted tracer [64Cu]FBP8 to assess for intracardiac thrombus. | Transesophageal echocardiography (TEE) is an ultrasound imaging procedure performed via the esophagus to provide direct visualization of the left atrial appendage and detect intracardiac thrombus. |
| Role in trial | PET/MR imaging with [64Cu]FBP8 is being tested as an investigational technique for early detection of intracardiac thrombus in cardiac amyloidosis. | TEE serves as the protocol-defined clinical reference standard to determine whether thrombus is present for comparison with the investigational PET/MR scan. |
| Primary use | Intended to provide high-resolution detection and characterization of intracardiac thrombus targeting fibrin, specifically in patients with cardiac amyloidosis and atrial arrhythmia. | Standard method for assessing left atrial appendage thrombus, guiding clinical decisions about anticoagulation and procedural risk. |
| How it is given or performed | A small amount of [64Cu]FBP8 tracer is injected intravenously, then participants undergo simultaneous cardiac PET/MR imaging to visualize fibrin-rich thrombus. | Ultrasound probe is inserted into the esophagus under sedation to obtain high-resolution images of the heart and left atrial appendage. |
| Evidence status | Clinical trial evidence for [64Cu]FBP8 PET/MR in the amyloidosis population is currently limited; prior studies have demonstrated fibrin-targeted PET/MR can detect thrombus in humans but routine use in cardiac amyloidosis requires ongoing validation. | TEE is extensively validated for detection of left atrial thrombus and is considered highly accurate for guiding clinical management. |
| Important limitations | [64Cu]FBP8 PET/MR is investigational, may be limited by availability, scanning duration, radiation exposure, and contraindications for MRI or PET in some patients. | TEE requires sedation and may be contraindicated for patients with esophageal pathology, electrical implants, or who cannot tolerate probe insertion. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Within 1 day
Participants receive an injection of the [64Cu]FBP8 tracer followed by simultaneous cardiac PET/MR imaging to detect intracardiac thrombi. Imaging results will be compared to recent or upcoming transesophageal echocardiogram (TEE) tests.
1 visit (in-person)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Lead Sponsor