Structural & Functional Impairment of Multiple Organs in Patients With

Status Recruiting

Clinical 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 damage of heart, brain and kidney.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05297474
Study type	Observational
Source	Tsinghua University
Contact	Xihai Zhao, PhD
Phone	861062792662
Email	xihaizhao@tsinghua.edu.cn
Status	Recruiting
Phase
Start date	July 1, 2021
Completion date	December 1, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03274076` - Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)	Phase 1/Phase 2
Completed	`NCT04300426` - Safety and Efficacy of Anaerobic Cultivated Human Intestinal Microbiome Transplantation in Systemic Sclerosis (ReSScue)	Phase 2
Recruiting	`NCT06058091` - RY_SW01 Cell Injection Therapy in Systemic Sclerosis	Phase 1/Phase 2
Recruiting	`NCT04356755` - Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma.	Phase 2
Suspended	`NCT06210945` - Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Sclerosis	Phase 2
Not yet recruiting	`NCT05947682` - Manufacturing of Allogeneic Adipose Tissue-derived Mesenchymal Stromal Cells for Treatment of Severe Systemic Sclerosis	N/A
Not yet recruiting	`NCT05177380` - Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis	N/A
Not yet recruiting	`NCT04303208` - Sirtuin 3 and Sirtuin 7 in Systemic Sclerosis	N/A
Recruiting	`NCT02551042` - CSL Behring Sclero XIII	Phase 2
Terminated	`NCT02246348` - Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc)	N/A
Terminated	`NCT02243111` - Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) by Ultrasound	N/A
Completed	`NCT01933334` - Safety and Tolerability of Pirfenidone in Patients With Systemic Sclerosis−Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)	Phase 2
Completed	`NCT01468792` - Hemodynamic Changes in Connective Tissue Disease	N/A
Terminated	`NCT00848107` - Open-Label Study of Oral Treprostinil in Digital Ulcers	Phase 2
Completed	`NCT00984932` - Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension	Phase 3
Completed	`NCT00074568` - Scleroderma Registry
Not yet recruiting	`NCT06412614` - Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies
Terminated	`NCT00622687` - Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis	Phase 2
Recruiting	`NCT04464434` - Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis	Phase 4
Recruiting	`NCT04246528` - SPIN Self-Management Feasibility Trial With Progression to Full-scale Trial (SPIN-SELF)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms