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

Amyloid Clinical Trial

— AMYLOCARP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05150353
• Other study ID #: 2018-A00881-54 Promoteur
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2020
• Est. completion date: April 24, 2022

Study information

• Verified date: November 2021
• Source: Ramsay Générale de Santé
• Contact: Jean-François Oudet
• Phone: 0683346567
• Email: jf.oudet[@]ecten.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: April 24, 2022
• Est. primary completion date: October 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyloid
• Amyloidosis
• Plaque, Amyloid
• Systemic Amyloidosis

Intervention

Procedure:
• MRI
Wrist MRI

Locations

Country	Name	City	State
France	Hôpital Privé Paul d'Egine	Champigny-sur-Marne

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T1 measurement (ms) associated with each of the 5 regions of interest at the wrist		1 day