Diagnostic and Imaging Indicators of Immunocardiomyopathic Patients

• Conditions: Autoimmune Diseases

• Registration Number: NCT03885375
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

Cardiac involvements in autoimmune diseases (AD) is common but underestimated and an early detection remains a clinical challenge for lacking of efficient imaging methods. The objective of the study was to investigate LV myocardial abnormalities in AD patients by multimodal cardiac imaging, including speckle-tracking echocardiology (STE), cardiac magnetic resonance imaging (CMRI) and positron emission tomography (PET).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-01
• Status Verified: 2018-09
• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-03-19
• Last Update Submitted: 2019-03-19
• Study First Posted: 2019-03-21
• Last Update Posted: 2019-03-21
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patient is diagnosed with autoimmune diseases, including systemic lupus erythematosus (SLE), vasculitis, dermatomyositis, sjogren's syndrome, scleroderma, rheumatoid arthritis and IgG4 associated disease.
• Patient is capable of complying with study procedures

Exclusion Criteria

• Patient is pregnant or nursing
• Patient is complicated with congenital heart disease
• Patient had cardiac surgery before
• Patient is complicated with serious infections
• Patient is complicated with organ failure
• Patient is complicated with tumors
• Patient is diagnosed indefinitely
• Patient has been involved in other clinical trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression of myocardial fibrosis and edema during follow-up period	1 year - 2 years	Late Gadolinium Enhanced, T1 mapping and T2 mapping tested by CMRI
Change in deformational parameters in echocardiography during follow-up period	6 months - 1 year - 2 years	global longitudinal strain (%), circumferential strain (%) and radial strain (%) measured by STE in autoimmune diseases
Change in myocardial perfusion during follow-up period	1 year - 2 years	SUVmax examined by PET

Trial Locations

Locations (1)

Peking Union Medical College Hostipal; 🇨🇳 Beijing, Beijing, China