Myocardial Inflammation in Systemic Lupus Erythematosus

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Stacy Ardoin MD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01761422
First received: January 3, 2013
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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


Condition
SLE

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Myocardial Inflammation in Systemic Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • T2 edema on Cardiac MRI [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Compare T2 edema at flare and 3 months later


Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
SLE active flare
Patients who are having an active flare of their lupus confirmed by labs

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761422

Locations
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
Principal Investigator: Stacy Ardoin, MD Ohio State University
  More Information

No publications provided

Responsible Party: Stacy Ardoin MD, Assistant Professor-Clinical, The Ohio State University
ClinicalTrials.gov Identifier: NCT01761422     History of Changes
Other Study ID Numbers: 2012H0132
Study First Received: January 3, 2013
Last Updated: January 23, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Inflammation
Lupus Erythematosus, Systemic
Myocarditis
Pathologic Processes
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014