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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
Sponsor:
Information provided by (Responsible Party):
Stacy Ardoin MD, Ohio State University

Study Description
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Brief Summary:
The goal is to assess for myocardial edema on cardiac MRI during SLE flare to assess for myocardial inflammation.

Condition or disease
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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema Lupus

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


Outcome Measures
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Primary Outcome Measures :
  1. T2 edema on Cardiac MRI [ Time Frame: 3 months ]
    Compare T2 edema at flare and 3 months later


Eligibility Criteria
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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
Study Population
Adults ages 18 years and older who are diagnosed with SLE
Criteria

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
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Information from the National Library of Medicine

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


Locations
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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         
Sponsors and Collaborators
Stacy Ardoin MD
Investigators
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Principal Investigator: Stacy Ardoin, MD Ohio State University
More Information
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Responsible Party: Stacy Ardoin MD, Assistant Professor-Clinical, Ohio State University
ClinicalTrials.gov Identifier: NCT01761422     History of Changes
Other Study ID Numbers: 2012H0132
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: January 24, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Myocarditis
Lupus Erythematosus, Systemic
Inflammation
Pathologic Processes
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases