Myocardial Inflammation in Systemic Lupus Erythematosus

SLE Clinical Trial

Official title:

Myocardial Inflammation in Systemic Lupus Erythematosus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01761422
• Other study ID #: 2012H0132
• Status: Active, not recruiting
• Start date: July 1, 2012
• Est. completion date: November 2025

Study information

• Verified date: October 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: November 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Lupus Erythematosus, Systemic
• Myocarditis
• SLE

Locations

Country	Name	City	State
United States	Stacy Payne Ardoin	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Stacy Ardoin MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T2 edema on Cardiac MRI	Compare T2 edema at flare and 3 months later	3 months