Clinical trial NCT05297474: Structural and Functional Impairment of Multiple Organs in Patients With Systemic Sclerosis: A MR Imaging Study
Official title: Structural and Functional Impairment of Multiple Organs in Patients With Systemic Sclerosis: A MR Imaging Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Sclerosis
Multisystem Disorder
Lead sponsor: Tsinghua University
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
First posted: 2022-03-28
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of structural and functional disorders of heart, brain and kidney in SSc patients.
timeFrame: 1year.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Huilin He
city: Beijing
country: China
facility: China Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University
Study officials:
affiliation: Peking Union Medical College Hospital
name: Huilin He, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tsinghua University
name: Chenlin Du, PhD
role: PRINCIPAL_INVESTIGATOR
References: