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Status unknownNCT05297474Updated Mar 29, 2022

Structural and Functional Impairment of Multiple Organs in Patients With Systemic Sclerosis: A MR Imaging Study

An observational study in Systemic Sclerosis and Multisystem Disorder, sponsored by Tsinghua University. Status unknown at 2 sites in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-29.

Sponsored by Tsinghua University · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
95
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study intends to carry out a prospective, multi-center cohort study based on MRI to explore the incidence of structural and functional damage of central, brain and kidney in patiant with SSc and its clinical relevance, and to search for the characteristics of serological markers of structural and functional damage of heart, brain and kidney.

Read the detailed description

Systemic sclerosis (SSc) is a autoimmune disease of unknown etiology with an estimated global incidence of 0.1‰. SSc characterized by abnormal immune activation, neovascularization, vascular remodeling in pathology, and eventually leads to fibrosis of tissues, skin, and organs [2]. In addition to skin sclerosis, SSc often involved multiple organ involvement, such as finger ulcer, gastroesophageal reflux, interstitial lung disease, pulmonary hypertension, cardiomyopathy, kidney damage, etc. Neuropsychiatric manifestations such as anxiety and depression may also occur in SSc patients. A long-term follow-up study indicated that cardiomyopathy (14%), cardiovascular disease (12%), and kidney injury (4%) were important causes of death in SSc patients. Therefore, early diagnosis and early intervention for multi-organ complications of SSc can significantly prolong the survival time of SSc patients.Magnetic resonance imaging (MRI) is a non-invasive, radiation-free imaging examination method with excellent soft tissue contrast, which can achieve one-stop multi-parameter imaging. At present, MRI has been widely used to accurately diagnose and evaluate the structure and function of organs such as heart, brain and kidney. Previous literature has shown that cardiac MRI can identify cardiac injury in patients with SSc earlier than echocardiography even in the early stage. Meanwhile it can find the abnormalities before clinical symptoms. Therefore, MRI is an effective noninvasive imaging method to evaluate the structural and functional damage of heart, brain and kidney in SSc patients.

02

Conditions studied

  • Systemic Sclerosis
  • Multisystem Disorder
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In context

Scleroderma, Systemic

688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.

This study's planned enrollment of 95 is close to the median of 100 across 169 observational studies indexed under Scleroderma, Systemic.

Browse Scleroderma, Systemic studies →

Lead sponsor

Tsinghua University is the lead sponsor of 24 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

In this study, we plan to recruit patients with systemic sclerosis and to explore the incidence and clinical correlation of structural and functional damage of heart, brain and kidney by MRI.The patients will be recruited in China.

Inclusion criteria

Clinical diagnosis of systemic sclerosis

Exclusion criteria

Exclusion Criteria:

Complicated with other immune disease Claustrophobia Contraindications for MR examination Heart or respiratory failure Diseases that affect MR findings (e.g. rapid atrial fibrillation) Complicated with heart, brain and kidney diseases not caused by SSc(such as diabetic nephropathy and congenital heart disease) Pregnant Disturbance of consciousness

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
95 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • SSc patiant

    We recruited 95 patients with systemic sclerosis

    Other: MRI

  • health control

    We recruited 95 healthy people for control

    Other: MRI

Interventions

  • OtherMRI

    No intervention was performed in this study.

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What researchers measure

Primary outcomes

  1. The incidence of structural and functional disorders of heart, brain and kidney in SSc patients.

    The incidence of structural and functional disorders of heart, brain and kidney in SSc patients.

    Time frame: 1year.

07

Study locations

2 of 2 sites recruiting
  • Huilin He
    Beijing, 100032, China
    • Huilin He, MD · Contact · hh_huilin@qq.com · 8615801455216
    • Dong Xu, PhD · Principal investigator
    Recruiting
  • China Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University
    Beijing, 100084, China
    Recruiting
08

References and documents

Study documents

  • Protocol and informed consent form · Nov 30, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05297474
Lead sponsor
Tsinghua University
Collaborators
Peking Union Medical College Hospital
Responsible party
Xihai Zhao (Professor, Tsinghua University) — Principal investigator
First posted
Mar 28, 2022
Start date
Jul 1, 2021
Primary completion
Jul 1, 2022 (estimated)
Completion
Dec 1, 2022 (estimated)
Last update
Mar 29, 2022

Study contacts

Xihai Zhao, PhD
Contact
xihaizhao@tsinghua.edu.cn
861062792662
Dong Xu, PhD
Contact
xudong74@hotmail.com
861062792662
Huilin He, MD
principal investigator · Peking Union Medical College Hospital
Chenlin Du, PhD
principal investigator · Tsinghua University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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