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

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.

Study Overview

• Status: Recruiting
• Conditions: Systemic Sclerosis; Multisystem Disorder
• Intervention / Treatment: Other: MRI

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.

• Study Type: Observational
• Enrollment (Anticipated): 95

Contacts and Locations

• Study Contact: Name: Xihai Zhao, PhD; Phone Number: 861062792662; Email: xihaizhao@tsinghua.edu.cn
• Study Contact Backup: Name: Dong Xu, PhD; Phone Number: 861062792662; Email: xudong74@hotmail.com

Study Locations

• China
  • Beijing, China, 100032
    • Recruiting
    • Huilin He
    • Contact: Huilin He, MD; Phone Number: 8615801455216; Email: hh_huilin@qq.com
    • Principal Investigator: Dong Xu, PhD
  • Beijing, China, 100084
    • Recruiting
    • China Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University
    • Contact: Yandong Zhu, B.S.; Phone Number: 861062796175; Email: yandong2012@tsinghua.edu.cn
    • Principal Investigator: Xihai Zhao, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SSc patiant; We recruited 95 patients with systemic sclerosis	Other: MRI; No intervention was performed in this study.
health control; We recruited 95 healthy people for control	Other: MRI; No intervention was performed in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Tsinghua University
• Collaborators: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Huilin He, MD, Peking Union Medical College Hospital; Principal Investigator: Chenlin Du, PhD, Tsinghua University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Connective Tissue Diseases; Sclerosis; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: 12040740374

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No