Using [64Cu]FBP8 PET/MR to find intracardiac blood clots in cardiac amyloidosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 pilot will enroll 20 participants with transthyretin or light-chain cardiac amyloidosis and atrial fibrillation or atrial flutter to undergo simultaneous [64Cu]FBP8 PET/MR imaging. Imaging results will be compared to transesophageal echocardiogram (TEE) as the reference standard, with the primary hypothesis that PET/MR will identify >90% of confirmed intracardiac thrombi. The protocol permits retrospective enrollment if a qualifying TEE was done within 14 days (or within 72 hours if anticoagulation was changed) and requires coordinated TEE timing for prospective participants. Secondary analyses will explore relationships between thrombus presence, left atrial function, and left ventricular amyloid burden.

Why it matters

Who can join: the full rules

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);

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Vicente Morales Oyarvide, MD, MPH
• Email: vmorales-oyarvide@bwh.harvard.edu
• Phone: 6172335860

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.