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

NCT ID: NCT05297474

Last Updated: 2022-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Systemic Sclerosis Multisystem Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SSc patiant

We recruited 95 patients with systemic sclerosis

MRI

Intervention Type OTHER

No intervention was performed in this study.

health control

We recruited 95 healthy people for control

MRI

Intervention Type OTHER

No intervention was performed in this study.

Interventions

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MRI

No intervention was performed in this study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Clinical diagnosis of systemic sclerosis

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

Tsinghua University

OTHER

Sponsor Role lead

Responsible Party

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Xihai Zhao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huilin He, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Chenlin Du, PhD

Role: PRINCIPAL_INVESTIGATOR

Tsinghua University

Locations

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Huilin He

Beijing, , China

Site Status RECRUITING

China Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xihai Zhao, PhD

Role: CONTACT

861062792662

Dong Xu, PhD

Role: CONTACT

861062792662

Facility Contacts

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Huilin He, MD

Role: primary

8615801455216

Yandong Zhu, B.S.

Role: primary

861062796175

Provided Documents

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Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

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12040740374

Identifier Type: -

Identifier Source: org_study_id

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