NCT07648303Recruiting
Prevalence of Cardiac Thrombi in Cardiac Amyloidosis
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 10 Jun 2026
- Start date
- Sept 2026
- Primary completion date
- Sept 2030
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Diseases
- Amyloidosis
- NCT number
- NCT07648303
What you commit to
- Study type: Interventional
- Planned participants: 200
- From Sept 2026 to the primary completion date, Sept 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Anyone with a known allergy to iodinated contrast agents
- Individuals with a known history of cardiac thrombus
- Individuals with a history of percutaneous or surgical closure of the left atrial appendage
Lab values
- Individuals with an estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m²
Other
- Overt thyrotoxicosis
- Uncontrolled asthma
- Individuals not enrolled in or not eligible for a social security program
- Individuals under legal guardianship
- Individuals under conservatorship
- Pregnant or breastfeeding women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Dijon Bourogne Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.