Back to resultsDetection of Amyloid Deposits in the Wrist by MRI With Mapping and High Resolution Sequences in Systemic Amyloidosis (AMYLOCARP) (AMYLOCARP)
Primary Purpose
Amyloid, Systemic Amyloidosis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional screening trial for Amyloid
Eligibility Criteria
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.
Sites / Locations
- Hôpital Privé Paul d'EgineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Patients with cardiac amyloidosis
Healthy volunteers
Arm Description
Outcomes
Primary Outcome Measures
T1 measurement (ms) associated with each of the 5 regions of interest at the wrist
Secondary Outcome Measures
Full Information
NCT ID
NCT05150353
First Posted
November 25, 2021
Last Updated
November 25, 2021
Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network
1. Study Identification
Unique Protocol Identification Number
NCT05150353
Brief Title
Detection of Amyloid Deposits in the Wrist by MRI With Mapping and High Resolution Sequences in Systemic Amyloidosis (AMYLOCARP)
Acronym
AMYLOCARP
Official Title
Detection of Amyloid Deposits in the Wrist by MRI With Mapping and High Resolution Sequences in Systemic Amyloidosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2020 (Actual)
Primary Completion Date
October 24, 2021 (Actual)
Study Completion Date
April 24, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyloid, Systemic Amyloidosis
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with cardiac amyloidosis
Arm Type
Experimental
Arm Title
Healthy volunteers
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
MRI
Intervention Description
Wrist MRI
Primary Outcome Measure Information:
Title
T1 measurement (ms) associated with each of the 5 regions of interest at the wrist
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-François Oudet
Phone
0683346567
Email
jf.oudet@ecten.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Hélène Barba
Email
mh.barba@ecten.eu
Facility Information:
Facility Name
Hôpital Privé Paul d'Egine
City
Champigny-sur-Marne
ZIP/Postal Code
94500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruxandra COSSON-STANESCU, Dr
Phone
0612247248
Email
ruxandra.cosson@wanadoo.fr
12. IPD Sharing Statement
Learn more about this trial
Detection of Amyloid Deposits in the Wrist by MRI With Mapping and High Resolution Sequences in Systemic Amyloidosis (AMYLOCARP)
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