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

R

Ramsay Générale de Santé

Status

Unknown

Conditions

Amyloid
Systemic Amyloidosis

Treatments

Procedure: MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT05150353
2018-A00881-54 Promoteur

Details and patient eligibility

About

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.

Enrollment

140 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Screening

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

140 participants in 2 patient groups, including a placebo group

Patients with cardiac amyloidosis
Experimental group
Treatment:
Procedure: MRI
Healthy volunteers
Placebo Comparator group
Treatment:
Procedure: MRI

Trial contacts and locations

1

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Central trial contact

Jean-François Oudet; Marie-Hélène Barba

Data sourced from clinicaltrials.gov

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