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.