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Diagnostic and Imaging Indicators of Immunocardiomyopathic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885375
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease
Autoimmune Diseases

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Multimodal Imaging Evaluation of Myocardial Involvement in Immunocardiomyopathic Patients
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in deformational parameters in echocardiography during follow-up period [ Time Frame: 6 months - 1 year - 2 years ]
    global longitudinal strain (%), circumferential strain (%) and radial strain (%) measured by STE in autoimmune diseases

  2. Progression of myocardial fibrosis and edema during follow-up period [ Time Frame: 1 year - 2 years ]
    Late Gadolinium Enhanced, T1 mapping and T2 mapping tested by CMRI

  3. Change in myocardial perfusion during follow-up period [ Time Frame: 1 year - 2 years ]
    SUVmax examined by PET



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885375


Contacts
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Contact: Wei Chen, MD 13911363358 chen_wei0201@aliyun.com

Locations
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China, Beijing
Peking Union Medical College Hostipal Recruiting
Beijing, Beijing, China, 100010
Contact: Wei Chen, MD    13911363358    chen_wei0201@aliyun.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Additional Information:

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03885375    
Other Study ID Numbers: Immunocardiomyopathy
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autoimmune Diseases
Immune System Diseases