Myocardial Inflammation in Systemic Lupus Erythematosus
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|ClinicalTrials.gov Identifier: NCT01761422|
Recruitment Status : Unknown
Verified January 2014 by Stacy Ardoin MD, Ohio State University.
Recruitment status was: Recruiting
First Posted : January 4, 2013
Last Update Posted : January 24, 2014
|Condition or disease|
The over-arching goal of this work is to further the understanding of myocardial damage in systemic lupus erythematosus (SLE) using state of the art CV imaging to investigate a novel potential mechanism of CV injury in SLE, subclinical myocardial inflammation.
Aim 1: Investigate an alternative pathway for CV morbidity in SLE by measuring myocardial edema at time of moderate to severe flare and compare values to post-flare studies and historical healthy controls.
Hypothesis 1: Myocardial edema, measured quantitatively with T2 CMR mapping during moderate to severe SLE flare will be significantly increased compared to 1) historical controls and 2) in SLE patients after resolution of flare.
Aim 2: Perform exploratory analyses investigating relationships between myocardial edema on CMR and markers of SLE disease activity and CV risk factors.
Hypothesis 2: Markers of disease activity including inflammatory makers (ESR and high sensitivity c-reactive protein), complement and autoantibody levels will predict the presence of T2 CMR detected myocardial edema during flare.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Myocardial Inflammation in Systemic Lupus Erythematosus|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||July 2016|
SLE active flare
Patients who are having an active flare of their lupus confirmed by labs
- T2 edema on Cardiac MRI [ Time Frame: 3 months ]Compare T2 edema at flare and 3 months later
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): NCT01761422
|United States, Ohio|
|Columbus, Ohio, United States, 43210|
|Contact: Amanda S Kibler, BS 614-366-4982 firstname.lastname@example.org|
|Principal Investigator: Stacy Ardoin, MD|
|Principal Investigator:||Stacy Ardoin, MD||Ohio State University|