NCT00563082

Brief Summary

Systemic lupus erythematosus (SLE) is an autoimmune disease that predominantly affects younger premenopausal women. The risk of coronary heat disease (CHD) in women with SLE is up to 50 times higher than in the general population. The conventional risk factors are insufficient to explain this increased risk of CHD in SLE-affected women. This study will perform genetic analysis to determine if genetic variation in the F2 gene is associated with both SLE risk and CHD risk in women with SLE.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,254

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2000

Longer than P75 for all trials

Status
completed

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 Start

First participant enrolled

May 1, 2000

Completed
7.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
Last Updated

November 18, 2023

Status Verified

March 1, 2014

First QC Date

November 21, 2007

Last Update Submit

November 16, 2023

Conditions

Lupus Erythematosus, Systemic

Keywords

SLEGenetics

Outcome Measures

Primary Outcomes (1)

  • Rare and common variants of F2 that contribute to SLE risk and CHD risk in SLE

    Measured at Year 4

Study Arms (2)

1

SLE participants positive for both APA and CHD

2

Normal participants with a high titer of APA

Eligibility Criteria

Age18 Years - 79 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will include genetic samples from women with SLE and CHD and from normal control women. The population will be 80.5% U.S. white women and 19.5% U.S. black women.

You may qualify if:

  • Diagnosis of SLE

You may not qualify if:

  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

DNA and serum

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • M. Ilyas Kamboh, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 26, 2007

Study Start

May 1, 2000

Study Completion

August 1, 2007

Last Updated

November 18, 2023

Record last verified: 2014-03