Prevalence of Cardiac Thrombi in Cardiac Amyloidosis | NCT07648303

Studies
Prevalence of Cardiac Thrombi in Cardiac Amyloidosis

NCT07648303

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Not yet recruiting

Last Update Posted

Jun 16, 2026Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Cardiac Amyloidosis

Interventions

Cardiac CT scan with contrast

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2026Estimated

Primary Completion Date

Jul 2028Estimated

Completion Date

Jul 2028Estimated

First Submitted Date

Jun 10, 2026

First Submission Date that Met QC Criteria

Jun 10, 2026

First Posted Date

Jun 15, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2026

Last Update Posted Date

Jun 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Individuals with intracardiac amyloidosis	Other		Procedure: Cardiac CT scan with contrast

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac CT scan with contrast	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	During the first two months following enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Benjamin FERRAND	Contact	03.80.29.35.36	+33	benjamin.ferrand@chu-dijon.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Dijon Bourogne		Dijon		21000	France

Condition Browse Module

MeSH Terms

ID	Term
D028227	Amyloid Neuropathies, Familial

Ancestor Terms

ID	Term
D020271	Heredodegenerative Disorders, Nervous System
D019636	Neurodegenerative Diseases
D009422	Nervous System Diseases
D017772	Amyloid Neuropathies

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003287	Contrast Media

Ancestor Terms

ID	Term
D064907	Diagnostic Uses of Chemicals
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D020313	Specialty Uses of Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided