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
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Condition or disease |
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SLE |
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 |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |

Group/Cohort |
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SLE active flare
Patients who are having an active flare of their lupus confirmed by labs
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- T2 edema on Cardiac MRI [ Time Frame: 3 months ]Compare T2 edema at flare and 3 months later

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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• Diagnosis of SLE by American College of Rheumatology Classification Criteria [21]
- 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:
- Pregnant
- 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

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 | |
OSUMC | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Amanda S Kibler, BS 614-366-4982 amanda.kibler@osumc.edu | |
Principal Investigator: Stacy Ardoin, MD |
Principal Investigator: | Stacy Ardoin, MD | Ohio State University |
Responsible Party: | Stacy Ardoin MD, Assistant Professor-Clinical, Ohio State University |
ClinicalTrials.gov Identifier: | NCT01761422 |
Other Study ID Numbers: |
2012H0132 |
First Posted: | January 4, 2013 Key Record Dates |
Last Update Posted: | January 24, 2014 |
Last Verified: | January 2014 |
Myocarditis Lupus Erythematosus, Systemic Inflammation Pathologic Processes Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Cardiomyopathies Heart Diseases Cardiovascular Diseases |