- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07648303
Prevalence of Cardiac Thrombi in Cardiac Amyloidosis (CATICA)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Benjamin FERRAND
- Telefonnummer: +33 03.80.29.35.36
- E-post: benjamin.ferrand@chu-dijon.fr
Studiesteder
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Dijon, Frankrike, 21000
- Rekruttering
- Chu Dijon Bourogne
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Ta kontakt med:
- Benjamin FERRAND
- Telefonnummer: +33 03.80.29.35.36
- E-post: benjamin.ferrand@chu-dijon.fr
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Annen: Individuals with intracardiac amyloidosis
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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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Presence of an intracardiac thrombus (atrial or ventricular) detected by a contrast-enhanced CT scan performed within the first two months following enrollment
Tidsramme: During the first two months following enrollment
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To determine the prevalence of intracardiac thrombi (atria and ventricles) diagnosed by contrast-enhanced cardiac CT in all patients treated for cardiac amyloidosis
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During the first two months following enrollment
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i nervesystemet
- Nevromuskulære sykdommer
- Metabolisme, medfødte feil
- Genetiske sykdommer, medfødte
- Metabolske sykdommer
- Sykdommer i det perifere nervesystemet
- Nevrodegenerative sykdommer
- Heredodegenerative lidelser, nervesystemet
- Proteostase mangler
- Amyloide nevropatier
- Amyloidose, familiær
- Amyloidose
- Medfødte, arvelige og neonatale sykdommer og abnormiteter
- Ernæringsmessige og metabolske sykdommer
- Amyloide neuropatier, familiær
- Farmakologiske handlinger
- Kjemiske handlinger og bruk
- Spesialbruk av kjemikalier
- Diagnostisk bruk av kjemikalier
- Kontrastmedier
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