An observational study in Systemic Sclerosis and Multisystem Disorder, sponsored by Tsinghua University. Status unknown at 2 sites in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-29.
Sponsored by Tsinghua University · Observational
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.
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.
688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.
This study's planned enrollment of 95 is close to the median of 100 across 169 observational studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Tsinghua University is the lead sponsor of 24 studies on the registry; 15 are open to participants now.
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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.
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
We recruited 95 patients with systemic sclerosis
Other: MRI
We recruited 95 healthy people for control
Other: MRI
No intervention was performed in this study.
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.
Time frame: 1year.
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Plan to share: No
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Tsinghua University