Myocardial Inflammation in Systemic Lupus Erythematosus

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

Study Overview

• Status: Active, not recruiting
• Conditions: SLE

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43221
      • Stacy Payne Ardoin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults ages 18 years and older who are diagnosed with SLE

Description

Inclusion Criteria:

• • 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
SLE active flare; Patients who are having an active flare of their lupus confirmed by labs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
T2 edema on Cardiac MRI	Compare T2 edema at flare and 3 months later	3 months

Collaborators and Investigators

• Sponsor: Stacy Ardoin MD
• Investigators: Principal Investigator: Stacy Ardoin, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: January 3, 2013
• First Submitted That Met QC Criteria: January 3, 2013
• First Posted (Estimated): January 4, 2013

Study Record Updates

• Last Update Posted (Estimated): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Cardiomyopathies; Lupus Erythematosus, Systemic; Inflammation; Myocarditis
• Other Study ID Numbers: 2012H0132