Prevalence of Cardiac Thrombi in Cardiac Amyloidosis (NCT07648303) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prevalence of Cardiac Thrombi in Cardiac Amyloidosis
France200 participantsStarted 2026-07
Plain-language summary
Cardiac amyloidosis (CA) is an infiltrative disease characterized by deposits of amyloid proteins of genetic or acquired origin (often in elderly patients), leading to heart failure and arrhythmias. More than 98% of currently diagnosed cases of cardiac amyloidosis result from fibrils composed of monoclonal immunoglobulin light chains (AL) or transthyretin (ATTR), in its hereditary (ATTRv) or acquired (ATTRwt) form.
Its prevalence is rising sharply due to an aging population and improved diagnostic techniques. Atrial fibrillation is responsible, in particular, for heart failure, arrhythmias, conduction disorders, and ischemic strokes, and is associated with significant morbidity and mortality. These patients have a much higher-than-normal risk of stroke because they are in a procoagulant state in the left atrium, even in the absence of atrial fibrillation. Intracardiac thrombi (ICTs) are present in 28% of patients with AC requiring cardioversion, compared with 2.5% of patients without AC, 50% of whom are on anticoagulants.
It has also been shown that the CHA2DS2-VASc score is not effective in predicting thromboembolic risk, and that direct oral anticoagulants (DOACs) are as effective as vitamin K antagonists (VKAs) in preventing embolisms.
The prevalence and factors associated with the development of intracardiac thrombi in patients with cardiac amyloidosis are unknown, as the available retrospective studies focused only on selected high-risk patients. Furthermore, tafamidis is now available to stabilize the course of cardiac amyloidosis and improve prognosis, but its effect on thromboembolic risk remains unknown.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Individuals with a diagnosis of cardiac amyloidosis (AL diagnosed by echocardiography and/or MRI combined with histological evidence; or ATTR diagnosed in the presence of typical cardiac abnormalities on echocardiography and/or MRI with cardiac hyperintensity)
* Individuals who have had at least one consultation related to their cardiac amyloidosis at the Dijon University Hospital during the year prior to enrollment
* Adults
Exclusion Criteria:
* Individuals with an estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m²
* Anyone with a known allergy to iodinated contrast agents
* Overt thyrotoxicosis
* Uncontrolled asthma
* Individuals with a known history of cardiac thrombus
* Individuals with a history of percutaneous or surgical closure of the left atrial appendage
* Individuals not enrolled in or not eligible for a social security program
* Individuals under legal guardianship
* Individuals under conservatorship
* Pregnant or breastfeeding women
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is focused on detecting blood clots inside the heart using contrast-enhanced CT scans, is that type of scan safe given my current heart and kidney function, and are there any risks I should know about before considering it?
2This trial is still listed as 'not yet recruiting' — how soon do you think it might open, and would it make sense for me to wait for it or should we be pursuing other evaluations or treatments in the meantime?
3The study is specifically measuring how common intracardiac thrombi are in cardiac amyloidosis patients — does my current situation suggest I might already be at higher risk for these clots, and would knowing that change how you'd manage my care?
4Since this appears to be an observational study rather than a treatment trial, what would happen if a clot were actually found on my CT scan — would I receive any treatment as a result, or would I need to seek that separately?
5Are there standard imaging tests or anticoagulation evaluations you would already recommend for someone with my type of cardiac amyloidosis, and how would joining this study overlap with or differ from what you'd do for my routine care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Presence of an intracardiac thrombus (atrial or ventricular) detected by a contrast-enhanced CT scan performed within the first two months following enrollment
Timeframe: During the first two months following enrollment