Detection of Amyloid Deposits in the Wrist by MRI With Mapping and High Resolution Sequences in Systemic Amyloidosis (AMYLOCARP)

Not Applicable

• Conditions: Amyloid; Systemic Amyloidosis
• Interventions: Procedure: MRI

• Registration Number: NCT05150353
• Lead Sponsor: Ramsay Générale de Santé

Brief Summary

This study is based on the hypothesis that MRI could make it possible to non-invasively detect these amyloid deposits at the level of the wrist using parametric sequences known as T1 mapping, in the form of an extension of T1 in the wrists. areas where amyloid deposits are found in the wrist.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-24
• Primary Completion: 2021-10-24
• Status Verified: 2021-11
• Study First Submitted: 2021-11-25
• Study First Submitted QC: 2021-11-25
• Last Update Submitted: 2021-11-25
• Study First Posted: 2021-12-09
• Last Update Posted: 2021-12-09
• Study Completion: 2022-04-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Patient group:

• Woman or man over 18 years old
• With ATTR or AL cardiac amyloidosis with or without carpal tunnel. The diagnosis of amyloidosis must be proven by a positive myocardial biopsy or diphosphonate scintigraphy.
• Affiliate or beneficiarie of a social security scheme.
• Having signed the free and informed consent.

Healthy volunteers:

• Woman or man over 18 years old
• Affiliate or beneficiarie of a social security scheme.
• Having signed the free and informed consent.

Exclusion Criteria

Patient group:

• Patients participating in another clinical study.
• Patients suffering from rheumatoid arthritis or other autoimmune disease (vasculitis, lupus, scleroderma, etc.)
• Patients with a medical history of wrist surgery (exclude the operated side).
• Patients with a contraindication to performing an MRI (pacemaker, etc.)
• Pregnant or breastfeeding women.
• Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision.

Healthy volunteer:

• Volunteers participating in another clinical study.
• Volunteers suffering from rheumatoid arthritis or other autoimmune disease (vasculitis, lupus, scleroderma, etc.)
• Pregnant or breastfeeding women.
• Volunteer with a contraindication to performing an MRI (pacemaker, etc.)
• Protected volunteers: Adults under guardianship, guardianship or other legal protection, deprived of their liberty by judicial or administrative decision.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with cardiac amyloidosis	MRI	-
Healthy volunteers	MRI	-

Primary Outcome Measures

Name	Time	Method
T1 measurement (ms) associated with each of the 5 regions of interest at the wrist	1 day

Trial Locations

Locations (1)

Hôpital Privé Paul d'Egine; 🇫🇷 Champigny-sur-Marne, France