Diagnostic and Imaging Indicators of Immunocardiomyopathic Patients
Multimodal Imaging Evaluation of Myocardial Involvement in Immunocardiomyopathic Patients
1 other identifier
observational
100
1 country
1
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).
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 Apr 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2018
CompletedFirst Submitted
Initial submission to the registry
January 2, 2019
CompletedFirst Posted
Study publicly available on registry
March 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedMarch 21, 2019
September 1, 2018
2 years
January 2, 2019
March 19, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
Change in myocardial perfusion during follow-up period
SUVmax examined by PET
1 year - 2 years
Eligibility 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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hostipal
Beijing, Beijing Municipality, 100010, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2019
First Posted
March 21, 2019
Study Start
April 1, 2018
Primary Completion
April 1, 2020
Study Completion
April 30, 2020
Last Updated
March 21, 2019
Record last verified: 2018-09