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

Systemic Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05297474
• Other study ID #: 12040740374
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: March 2022
• Source: Tsinghua University
• Contact: Xihai Zhao, PhD
• Phone: 861062792662
• Email: xihaizhao[@]tsinghua.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: December 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Other:
• MRI
No intervention was performed in this study.

Locations

Country	Name	City	State
China	China Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University	Beijing
China	Huilin He	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Tsinghua University	Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1year.