Systemic SclerosisNCT05297474
Structural and Functional Impairment of Multiple Organs in Patients With Systemic Sclerosis: A MR Imaging Study
An observational study of Systemic Sclerosis and Multisystem Disorder, run by Tsinghua University at 2 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis, Multisystem Disorder
- What is being tested?
- MRI
- How many people
- 95 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2021to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Clinical diagnosis of systemic sclerosis
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Huilin He
Beijing, 100032
Huilin He, MD, 8615801455216, hh_huilin@qq.com
Dong Xu, PhD
- Recruiting
China Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University
Beijing, 100084
Yandong Zhu, B.S., 861062796175, yandong2012@tsinghua.edu.cn
Xihai Zhao, PhD
About this 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.
Read the 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.
- Conditions
- Systemic Sclerosis, Multisystem Disorder
- Being tested
- MRI
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
No intervention was performed in this study.
| Study group | Role | What they receive |
|---|---|---|
| SSc patiant | We recruited 95 patients with systemic sclerosis Receives: Other: MRI | |
| health control | We recruited 95 healthy people for control Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Jul 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tsinghua University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital
- Responsible party
- Principal investigator, Xihai Zhao, Tsinghua University
- Investigators
- Huilin He, MD, Principal investigator, Peking Union Medical College HospitalChenlin Du, PhD, Principal investigator, Tsinghua University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297474
- Sponsor's protocol ID
- 12040740374
- Status last verified
- Mar 2022
- First submitted
- 17 Mar 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Functional Impairment of Multiple Organs in Patients With Systemic Sclerosis: A MR Imaging Study
- ClinicalTrials.gov ID
- NCT05297474
- Acronym / sponsor ID
- 12040740374
- Conditions
- Systemic Sclerosis, Multisystem Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Tsinghua UniversityUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSc patiant | – | Other: MRIWe recruited 95 patients with systemic sclerosis |
| health control | – | Other: MRIWe recruited 95 healthy people for control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Clinical diagnosis of systemic sclerosis
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRINo intervention was performed in this study. | Other | SSc patiant, health control |
Primary outcome
The incidence of structural and functional disorders of heart, brain and kidney in SSc patients.
Time frame: 1year.
The incidence of structural and functional disorders of heart, brain and kidney in SSc patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huilin He, MD principal investigator
Peking Union Medical College Hospital
Chenlin Du, PhD principal investigator
Tsinghua University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis and Multisystem Disorder, run by Tsinghua University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xihai Zhao, PhD (861062792662, xihaizhao@tsinghua.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of structural and functional disorders of heart, brain and kidney in SSc patients. (time frame: 1year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.