Atrial Fibrillation Clinical Trials

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[64Cu]FBP8 PET for Early Detection of Intracardiac Thrombus in Amyloid Cardiomyopathy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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;

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Vicente Morales Oyarvide, MD, MPH
vmorales-oyarvide@bwh.harvard.edu
6172335860
Backup
Sharmila Dorbala, MD, MPH
sdorbala@bwh.harvard.edu
617-732-6290
Time Frame
Start Date: 2026-05-01
Estimated Completion Date: 2027-03-30
Participants
Target number of participants: 20
Treatments
Other: [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.
Sponsors
Leads: Brigham and Women's Hospital

This content was sourced from clinicaltrials.gov