Cardiac AmyloidosisCATICANCT07648303
Prevalence of Cardiac Thrombi in Cardiac Amyloidosis
A study testing Cardiac CT scan with contrast in people with Cardiac Amyloidosis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Amyloidosis
- What is being tested?
- Cardiac CT scan with contrast
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2026to 7 Sep 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Individuals not enrolled in or not eligible for a social security program
- Individuals under legal guardianship
- Individuals under conservatorship
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourogne
Dijon, 21000
Benjamin FERRAND, 03.80.29.35.36 ext. +33, benjamin.ferrand@chu-dijon.fr
About this study
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.
Read more
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.
- Conditions
- Cardiac Amyloidosis
- Being tested
- Cardiac CT scan with contrast
- Medical subject headings
- Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CT scan with contrastProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with intracardiac amyloidosis | Other | Not described Receives: Procedure: Cardiac CT scan with contrast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the first two months following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start7 Sep 2026
- Primary completion7 Sep 2030 (estimated)
- Study completion7 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648303
- Sponsor's protocol ID
- GUENANCIA Astra Zeneca 2025
- Acronym
- CATICA
- Status last verified
- Sep 2026
- First submitted
- 10 Jun 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No