Diagnostic and Imaging Indicators of Immunocardiomyopathic Patients

Autoimmune Diseases Clinical Trial

Official title:

Multimodal Imaging Evaluation of Myocardial Involvement in Immunocardiomyopathic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03885375
• Other study ID #: Immunocardiomyopathy
• Status: Recruiting
• Start date: April 1, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: September 2018
• Source: Peking Union Medical College Hospital
• Contact: Wei Chen, MD
• Phone: 13911363358
• Email: chen_wei0201[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases

Locations

Country	Name	City	State
China	Peking Union Medical College Hostipal	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

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