Myocardial Inflammation in Systemic Lupus Erythematosus | NCT01761422

Studies
Myocardial Inflammation in Systemic Lupus Erythematosus

NCT01761422

Sponsor

Stacy Ardoin MD

Status

Active, not recruiting

Last Update Posted

Dec 18, 2025Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2012

Primary Completion Date

Nov 1, 2026Estimated

Completion Date

Nov 1, 2026Estimated

First Submitted Date

Jan 3, 2013

First Submission Date that Met QC Criteria

Jan 3, 2013

First Posted Date

Jan 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2025

Last Update Posted Date

Dec 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Label	Type	Description	Intervention Names
SLE active flare		Patients who are having an active flare of their lupus confirmed by labs

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
T2 edema on Cardiac MRI	Compare T2 edema at flare and 3 months later	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Adults ages 18 years and older who are diagnosed with SLE

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stacy Ardoin, MD	Ohio State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stacy Payne Ardoin		Columbus	Ohio	43221	United States