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NCT01761422 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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