Myocardial Inflammation in Systemic Lupus Erythematosus
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Myocardial Inflammation in Systemic Lupus Erythematosus|
- T2 edema on Cardiac MRI [ Time Frame: 3 months ] [ Designated as safety issue: No ]Compare T2 edema at flare and 3 months later
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
SLE active flare
Patients who are having an active flare of their lupus confirmed by labs
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761422
|United States, Ohio|
|Columbus, Ohio, United States, 43210|
|Contact: Amanda S Kibler, BS 614-366-4982 email@example.com|
|Principal Investigator: Stacy Ardoin, MD|
|Principal Investigator:||Stacy Ardoin, MD||Ohio State University|