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7.0 Tesla Resonance Magnetic Imaging of the Hand in Systemic Sclerosis (PREM'S)

Primary Purpose

Systemic Sclerosis, 7.0 Tesla Magnetic Resonance Imaging, Hand Vascular Involvement

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
7.0 T RMI
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Systemic Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with SSc:

    - ScS fulfilling ACR/EULAR 2013 classification criteria and followed in the department of internal medicine of Poitiers University Hospital, without clinical signs of digital arthrose

  • Control subjects:

    - Hospitalized patients in the department of internal medicine of Poitiers University Hospital, without Raynaud's phenomenon, neither antecedent of inflammatory rheumatism and/or autoimmune disease, neither inflammatory articular symptoms during the previous month and no clinical signs of arthoses and/or arthritis at the inclusion in the study

  • For both:

    • Age ≥ 18 years-old
    • Written informatory consent

Exclusion Criteria:

  • Patients with SSc:

    - SSc associated with other define autoimmune disease (overlap syndrome)

  • For both:

    • Absolute contraindication to 7.0 T RMI: pregnancy; ocular metallic foreign body ; cardiac pacemaker ; neurostimulator no compatible 7.0 T RMI ; cochlear implants; all electronic medical device implantedfor less than 6 weeks ; metallic heart valve ; old cranial vascular clips
    • Individuals with current health condition not allowing realization of the 7.0 T RMI in sufficient comfort conditions according to investigator appreciation (i.e. acute cardiac and/or respiratory failure, impossibility to maintain procubitus, bedridden individuals, claustrophobia)
    • Individuals under tutorship or guardianship
    • Individuals with reinforced protection: minors, judiciary or administrative decision
    • No affiliation to social insurance
    • Pregnancy or breastfeeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    7.0 Tesla MRI of both hands

    Arm Description

    Single 7.0 Tesla MRI of both hands for all the SSc and control subjects

    Outcomes

    Primary Outcome Measures

    Frequency of hand osteoarticular involvement in SSc and control subjects in 7.0 T RMI
    Frequency of type and localisation of hand osteoarticular abnormality (erosions, bone oedema, synovitis, tenosynovitis, intraarticular swoilling) in 7.0 T RMI in patients with SSc and control subjects

    Secondary Outcome Measures

    Arterial pattern in the hand of SSc patients and control subjects in 7.0 T RMI
    Digital arteries count in both hand in 7.0 T RMI in SSc patients and control subjects
    Arterial pattern in the hand of SSc patients and control subjects in 7.0 T RMI
    Lumen area of the selective section of the vessel (in mm2) in 7.0 T RMI in SSc patients and control subjects
    Arterial pattern in the hand of SSc patients and control subjects in 7.0 T RMI
    Quality of arterial opacification in terms of percentage of digital artery that did not reach the first phalanx, in 7.0 T RMI in SSc patients and control subjects
    Arterial pattern in the hand of SSc patients and control subjects in 7.0 T RMI
    Quality of venous return in terms of percentage of no visible venous return as far as the proximal phalanx in 7.0 T RMI in SSc patients and control subjects
    Correlation between hand osteoarticular involvement in 7.0 T RMI and general and SSc-related factors, including hand vascular involvement, in SSc patients
    Proportion of hand osteoarticular abnormalities and : age (yrs) ; SSc duration (yrs) ; bone mass index ; modified Rodnan skin score (0-51) ; interlabial length (cm) ; arterial pattern in the hand in 7.0 T RMI ; proportions of female, active tabagism, SSc subtypes, SSc-related autoantibodies, antiphospholipid autoantibodies, immunosuppressant use, vasoactive drugs and SSc-related visceral involvement (Raynaud's phenomenon, digital tip ulcerations and/or gangrene and/or amputation, arterial pulmonary hypertension, interstitial lung disease, upper and/or lower digital tract involvement, renal crisis, arthritis, inflammatory myopathy, subcutaneous calcifications, telangiectasia) ; EUSTAR-Activity Index ; NT-proBNP level (ng/mL) ; troponin level (ng/mL) ; C reactive protein level (mg/L) ; proportion of capillaroscopic pattern (cutulo's classification) ; Raynaud's Condition Score ; patient's visual scale for Raynaud's phenomenon severity (1 to 10) ; SSc-HAQ ; "main de Cochin" score
    Correlation between hand arterial involvement in 7.0 T RMI and general and SSc-related factors, including hand osteoarticular involvement, in SSc patients
    Proportion of hand hand arterial abnormalities and : age (yrs) ; SSc duration (yrs) ; bone mass index ; modified Rodnan skin score (0-51) ; interlabial length (cm) ; hand osteoarticular abnormalities in 7.0 T RMI ; proportions of female, active tabagism, SSc subtypes, SSc-related autoantibodies, antiphospholipid autoantibodies, immunosuppressant use, vasoactive drugs and SSc-related visceral involvement (Raynaud's phenomenon, digital tip ulcerations and/or gangrene and/or amputation, arterial pulmonary hypertension, interstitial lung disease, upper and/or lower digital tract involvement, renal crisis, arthritis, inflammatory myopathy, subcutaneous calcifications, telangiectasia) ; EUSTAR-Activity Index ; NT-proBNP level (ng/mL) ; troponin level (ng/mL) ; C reactive protein level (mg/L) ; proportion of capillaroscopic pattern (cutulo's classification) ; Raynaud's Condition Score ; patient's visual scale for Raynaud's phenomenon severity (1 to 10) ; SSc-HAQ ; "main de Cochin" score
    Sodium articular concentration in the hand in 7.0 T RMI in SSc patients and control subjects
    Mean values of sodium articular concentration in the hands of SSc patients of control subjects

    Full Information

    First Posted
    December 30, 2019
    Last Updated
    January 28, 2021
    Sponsor
    Poitiers University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04223817
    Brief Title
    7.0 Tesla Resonance Magnetic Imaging of the Hand in Systemic Sclerosis
    Acronym
    PREM'S
    Official Title
    Contribution of 7.0 Tesla RMI in Screening of Osteoarticular Involvement and Vasculopathy of the Hands in Systemic Sclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2021 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    December 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Poitiers University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Systemic sclerosis (SSc) is a rare systemic autoimmune disease with specific osteoarticular pattern of unknown mechanism. Ischemic phenomenon have been suggested to participate to the osteoarticular involvement in SSc. To date, osteoarticular pattern and hand vascular involvement have been few studied in magnetic resonance imaging in SSc, and most often with low resolution RMI. 7 Tesla RMI allows high resolution for morphology examination, together with dynamic and functional vascular study and sodium articular concentration. Indeed, the aim of the study is to describe hand osteoarticular and vascular involvement in SSc, as well as sodium articular concentration. Clinico-biological association will be also assessed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Systemic Sclerosis, 7.0 Tesla Magnetic Resonance Imaging, Hand Vascular Involvement, Hand Osteoarticular Involvement

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    SSc patients compared to control subjects without SSc matched on sex and age
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    7.0 Tesla MRI of both hands
    Arm Type
    Experimental
    Arm Description
    Single 7.0 Tesla MRI of both hands for all the SSc and control subjects
    Intervention Type
    Device
    Intervention Name(s)
    7.0 T RMI
    Intervention Description
    Single 7.0 Tesla MRI of both hands in the same time
    Primary Outcome Measure Information:
    Title
    Frequency of hand osteoarticular involvement in SSc and control subjects in 7.0 T RMI
    Description
    Frequency of type and localisation of hand osteoarticular abnormality (erosions, bone oedema, synovitis, tenosynovitis, intraarticular swoilling) in 7.0 T RMI in patients with SSc and control subjects
    Time Frame
    7 days maximum (delay between realization of the RMI and its final interpretation)
    Secondary Outcome Measure Information:
    Title
    Arterial pattern in the hand of SSc patients and control subjects in 7.0 T RMI
    Description
    Digital arteries count in both hand in 7.0 T RMI in SSc patients and control subjects
    Time Frame
    7 days maximum (delay between realization of the RMI and its final interpretation)
    Title
    Arterial pattern in the hand of SSc patients and control subjects in 7.0 T RMI
    Description
    Lumen area of the selective section of the vessel (in mm2) in 7.0 T RMI in SSc patients and control subjects
    Time Frame
    7 days maximum (delay between realization of the RMI and its final interpretation)
    Title
    Arterial pattern in the hand of SSc patients and control subjects in 7.0 T RMI
    Description
    Quality of arterial opacification in terms of percentage of digital artery that did not reach the first phalanx, in 7.0 T RMI in SSc patients and control subjects
    Time Frame
    7 days maximum (delay between realization of the RMI and its final interpretation)
    Title
    Arterial pattern in the hand of SSc patients and control subjects in 7.0 T RMI
    Description
    Quality of venous return in terms of percentage of no visible venous return as far as the proximal phalanx in 7.0 T RMI in SSc patients and control subjects
    Time Frame
    7 days maximum (delay between realization of the RMI and its final interpretation)
    Title
    Correlation between hand osteoarticular involvement in 7.0 T RMI and general and SSc-related factors, including hand vascular involvement, in SSc patients
    Description
    Proportion of hand osteoarticular abnormalities and : age (yrs) ; SSc duration (yrs) ; bone mass index ; modified Rodnan skin score (0-51) ; interlabial length (cm) ; arterial pattern in the hand in 7.0 T RMI ; proportions of female, active tabagism, SSc subtypes, SSc-related autoantibodies, antiphospholipid autoantibodies, immunosuppressant use, vasoactive drugs and SSc-related visceral involvement (Raynaud's phenomenon, digital tip ulcerations and/or gangrene and/or amputation, arterial pulmonary hypertension, interstitial lung disease, upper and/or lower digital tract involvement, renal crisis, arthritis, inflammatory myopathy, subcutaneous calcifications, telangiectasia) ; EUSTAR-Activity Index ; NT-proBNP level (ng/mL) ; troponin level (ng/mL) ; C reactive protein level (mg/L) ; proportion of capillaroscopic pattern (cutulo's classification) ; Raynaud's Condition Score ; patient's visual scale for Raynaud's phenomenon severity (1 to 10) ; SSc-HAQ ; "main de Cochin" score
    Time Frame
    7 days maximum (delay between realization of the RMI and its final interpretation)
    Title
    Correlation between hand arterial involvement in 7.0 T RMI and general and SSc-related factors, including hand osteoarticular involvement, in SSc patients
    Description
    Proportion of hand hand arterial abnormalities and : age (yrs) ; SSc duration (yrs) ; bone mass index ; modified Rodnan skin score (0-51) ; interlabial length (cm) ; hand osteoarticular abnormalities in 7.0 T RMI ; proportions of female, active tabagism, SSc subtypes, SSc-related autoantibodies, antiphospholipid autoantibodies, immunosuppressant use, vasoactive drugs and SSc-related visceral involvement (Raynaud's phenomenon, digital tip ulcerations and/or gangrene and/or amputation, arterial pulmonary hypertension, interstitial lung disease, upper and/or lower digital tract involvement, renal crisis, arthritis, inflammatory myopathy, subcutaneous calcifications, telangiectasia) ; EUSTAR-Activity Index ; NT-proBNP level (ng/mL) ; troponin level (ng/mL) ; C reactive protein level (mg/L) ; proportion of capillaroscopic pattern (cutulo's classification) ; Raynaud's Condition Score ; patient's visual scale for Raynaud's phenomenon severity (1 to 10) ; SSc-HAQ ; "main de Cochin" score
    Time Frame
    7 days maximum (delay between realization of the RMI and its final interpretation)
    Title
    Sodium articular concentration in the hand in 7.0 T RMI in SSc patients and control subjects
    Description
    Mean values of sodium articular concentration in the hands of SSc patients of control subjects
    Time Frame
    7 days maximum (delay between realization of the RMI and its final interpretation)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with SSc: - ScS fulfilling ACR/EULAR 2013 classification criteria and followed in the department of internal medicine of Poitiers University Hospital, without clinical signs of digital arthrose Control subjects: - Hospitalized patients in the department of internal medicine of Poitiers University Hospital, without Raynaud's phenomenon, neither antecedent of inflammatory rheumatism and/or autoimmune disease, neither inflammatory articular symptoms during the previous month and no clinical signs of arthoses and/or arthritis at the inclusion in the study For both: Age ≥ 18 years-old Written informatory consent Exclusion Criteria: Patients with SSc: - SSc associated with other define autoimmune disease (overlap syndrome) For both: Absolute contraindication to 7.0 T RMI: pregnancy; ocular metallic foreign body ; cardiac pacemaker ; neurostimulator no compatible 7.0 T RMI ; cochlear implants; all electronic medical device implantedfor less than 6 weeks ; metallic heart valve ; old cranial vascular clips Individuals with current health condition not allowing realization of the 7.0 T RMI in sufficient comfort conditions according to investigator appreciation (i.e. acute cardiac and/or respiratory failure, impossibility to maintain procubitus, bedridden individuals, claustrophobia) Individuals under tutorship or guardianship Individuals with reinforced protection: minors, judiciary or administrative decision No affiliation to social insurance Pregnancy or breastfeeding
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mickaël MARTIN, MD, PhD
    Phone
    0549444004
    Ext
    +33
    Email
    mickael.martin@chu-poitiers.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cédric LANDRON, MD, PhD
    Phone
    0549444004
    Ext
    +33
    Email
    cedric.landron@chu-poitiers.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    7.0 Tesla Resonance Magnetic Imaging of the Hand in Systemic Sclerosis

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