CompletedNot Applicable

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

France128 participantsStarted 2020-01-24

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 administrat…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

T1 measurement (ms) associated with each of the 5 regions of interest at the wrist

Timeframe: 1 day

Trial details

NCT IDNCT05150353

SponsorRamsay Générale de Santé

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-26

View on ClinicalTrials.gov More Amyloid trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.