ClinicalTrials.gg
RecruitingNCT07648303CATICAUpdated Sep 17, 2026

Prevalence of Cardiac Thrombi in Cardiac Amyloidosis

An interventional study of Cardiac CT scan with contrast in Cardiac Amyloidosis, sponsored by Centre Hospitalier Universitaire Dijon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Centre Hospitalier Universitaire Dijon · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 35 studies in Amyloid Neuropathies, Familial with a site in France — 15 open to participants now, 16 under way, 1 of them phase 3. Amyloid Neuropathies, Familial · France.

Planned enrollment
8th of 23
200 · median 128
Started
2026
with 2 others
No phase
10 of 35
5 open now
Primary completion
2030-09
later than 11 of 15 live
Registered
35th of 35
by date
Lead sponsor
1 of 35
Centre Hospitalier Universitaire Dijon

Among the 35 studies in Amyloid Neuropathies, Familial with a site in France, this one is the 8th largest by planned enrollment of the 23 interventional ones that give a count, is one of 3 that started in 2026, is one of 10 with no phase, reaches primary completion later than 11 of the 15 other live ones, and was the 35th registered.

Amyloid Neuropathies, Familial

188 studies on the registry are indexed under Amyloid Neuropathies, Familial; 94 are open to participants now.

Browse Amyloid Neuropathies, Familial studies →

Open to participants now

15 of the 35 studies in Amyloid Neuropathies, Familial with a site in France are open now. Recruiting first, the newest first:

9 more — sign in →

All 15 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 69 Amyloid Neuropathies, Familial studies recruiting now, 53 (77%) set no upper age limit and 1 (1%) stops at 75 or younger; 7 take children under 18; 9 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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.

03

Conditions studied

  • Cardiac Amyloidosis
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Individuals with an estimated (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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Other
    Individuals with intracardiac amyloidosis

    Procedure: Cardiac CT scan with contrast

Interventions

  • ProcedureCardiac CT scan with contrast

    A peripheral venous line will be inserted by the radiology technicians prior to the exam and removed at the end of the exam. Cardiac CT scan with Iomeron 400 injection, ECG synchronization and automatic spiral acquisition. Analysis of total cardiac mass. Post-processing using ADAS 3D Galgo and Syngovia software: detection of intracardiac thrombi, assessment of extracellular volume, measurement of atrial and ventricular volumes and epicardial fat.

06

What researchers measure

Primary outcomes

  1. Presence of an intracardiac thrombus (atrial or ventricular) detected by a contrast-enhanced CT scan performed within the first two months following enrollment

    To determine the prevalence of intracardiac thrombi (atria and ventricles) diagnosed by contrast-enhanced cardiac CT in all patients treated for cardiac amyloidosis

    Time frame: During the first two months following enrollment

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Sep 2030, 48 months after the start.

Of 30 interventional studies with no phase under Amyloid Neuropathies, Familial, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 67. This study's planned 48 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 10, 2026
First posted
Jun 15, 2026
StartActual
Sep 7, 2026
Primary completionEst.
Sep 7, 2030
CompletionEst.
Sep 7, 2030
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07648303
Responsible party
Sponsor
First posted
Jun 15, 2026
Start date
Sep 7, 2026
Primary completion
Sep 7, 2030 (estimated)
Completion
Sep 7, 2030 (estimated)
Last update
Sep 17, 2026

Study contacts

Benjamin FERRAND
Contact
benjamin.ferrand@chu-dijon.fr
03.80.29.35.36 ext. +33

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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