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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05150353
Other study ID # 2018-A00881-54 Promoteur
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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