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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05297474
Enrollment
95
Registered
2022-03-28
Start date
2021-07-01
Completion date
2022-12-01
Last updated
2022-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multisystem Disorder, Systemic Sclerosis

Brief 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.

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.

Interventions

OTHERMRI

No intervention was performed in this study.

Sponsors

Peking Union Medical College Hospital
CollaboratorOTHER
Tsinghua University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactXihai Zhao, PhD
xihaizhao@tsinghua.edu.cn861062792662
Backup ContactDong Xu, PhD
xudong74@hotmail.com861062792662

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026