Structural and Functional Impairment of Multiple Organs in Patients With Systemic Sclerosis: A MR Imaging Study
1 other identifier
observational
95
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2021
CompletedFirst Submitted
Initial submission to the registry
March 17, 2022
CompletedFirst Posted
Study publicly available on registry
March 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMarch 29, 2022
March 1, 2022
1 year
March 17, 2022
March 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (2)
SSc patiant
We recruited 95 patients with systemic sclerosis
health control
We recruited 95 healthy people for control
Interventions
Eligibility Criteria
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.
You may qualify if:
- Clinical diagnosis of systemic sclerosis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tsinghua Universitylead
- Peking Union Medical College Hospitalcollaborator
Study Sites (2)
Huilin He
Beijing, 100032, China
China Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University
Beijing, 100084, China
Biospecimen
ForIL-2/6/9、5Ht and PON-1
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huilin He, MD
Peking Union Medical College Hospital
- PRINCIPAL INVESTIGATOR
Chenlin Du, PhD
Tsinghua University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 17, 2022
First Posted
March 28, 2022
Study Start
July 1, 2021
Primary Completion
July 1, 2022
Study Completion
December 1, 2022
Last Updated
March 29, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share