NCT01761422

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started Jul 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jul 2012Nov 2026

Study Start

First participant enrolled

July 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

14.3 years

First QC Date

January 3, 2013

Last Update Submit

December 11, 2025

Conditions

SLE

Outcome Measures

Primary Outcomes (1)

  • T2 edema on Cardiac MRI

    Compare T2 edema at flare and 3 months later

    3 months

Study Arms (1)

SLE active flare

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adults ages 18 years and older who are diagnosed with SLE

You may qualify if:

  • 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.\[23\]

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stacy Payne Ardoin

Columbus, Ohio, 43221, United States

Location

Study Officials

  • Stacy Ardoin, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor-Clinical

Study Record Dates

First Submitted

January 3, 2013

First Posted

January 4, 2013

Study Start

July 1, 2012

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations

US(1)