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Trials / Active Not Recruiting

Active Not RecruitingNCT01761422

Myocardial Inflammation in Systemic Lupus Erythematosus

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
40 (estimated)
Sponsor
Stacy Ardoin MD · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

The goal is to assess for myocardial edema on cardiac MRI during SLE flare to assess for myocardial inflammation.

Detailed description

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.

Conditions

Timeline

Start date
2012-07-01
Primary completion
2026-11-01
Completion
2026-11-01
First posted
2013-01-04
Last updated
2025-12-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01761422. Inclusion in this directory is not an endorsement.