Myocardial Inflammation in Systemic Lupus Erythematosus
NCT ID: NCT01761422
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
40 participants
OBSERVATIONAL
2012-07-01
2026-11-01
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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SLE active flare
Patients who are having an active flare of their lupus confirmed by labs
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Active SLE Flare defined by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)\[22\] \> 6 or British Isles Lupus Assessment Group (BILAG) Index A or B.\[23\]
Exclusion Criteria
* Allergy to gadolinium
* Severe claustrophobia
* Renal replacement therapy or glomerular filtration rate (GFR) \< 30 mL/min/1.75m²
* Medically unstable for transportation to Ross MRI scanner. Stability will be defined as: not on mechanical ventilation, HR \< 120 BPM, MAP \> 65 mmHg. The treating providers' input on the patient's stability will also be considered in addition to these criteria
* Weight \> 500 pounds
* MR incompatible implanted devices such as neurostimulator pacemakers and implantable defibrillators, presence of intracranial metal or any metal not compatible with CMR
18 Years
60 Years
ALL
No
Sponsors
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Stacy Ardoin MD
OTHER
Responsible Party
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Stacy Ardoin MD
Assistant Professor-Clinical
Principal Investigators
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Stacy Ardoin, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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Stacy Payne Ardoin
Columbus, Ohio, United States
Countries
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Other Identifiers
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2012H0132
Identifier Type: -
Identifier Source: org_study_id