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Myocardial Inflammation in Systemic Lupus Erythematosus

Sponsor
Stacy Ardoin MD (Other)
Overall Status
Recruiting
CT.gov ID
NCT01761422
Collaborator
(none)
40
Enrollment
1
Location
132
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Myocardial Inflammation in Systemic Lupus Erythematosus
    Study Start Date :
    Jul 1, 2012
    Anticipated Primary Completion Date :
    Jul 1, 2023
    Anticipated Study Completion Date :
    Jul 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    SLE active flare

    Patients who are having an active flare of their lupus confirmed by labs

    Outcome Measures

    Primary Outcome Measures

    1. T2 edema on Cardiac MRI [3 months]

      Compare T2 edema at flare and 3 months later

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 OSUMC Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Stacy Ardoin MD

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stacy Ardoin MD, Assistant Professor-Clinical, Ohio State University
    ClinicalTrials.gov Identifier:
    NCT01761422
    Other Study ID Numbers:
    • 2012H0132
    First Posted:
    Jan 4, 2013
    Last Update Posted:
    Nov 2, 2021
    Last Verified:
    Oct 1, 2021
    Additional relevant MeSH terms:
    Myocarditis
    Lupus Erythematosus, Systemic
    Inflammation

    Study Results

    No Results Posted as of Nov 2, 2021