NCT04037293

Brief Summary

Patients with SLE have increased rates of atherosclerosis, while the risk factors for atherosclerosis in those patients were not fully revealed. This study is an observational study to investigate the natural process and risk factors for atherosclerosis based on a Chinese SLE cohort. Carotid intima media thickness (CIMT) and brachial-ankle pulse wave velocity (baPWV) will be measured for each patient at baseline and 5-year follow-up. Blood tests including cholesterol levels, fasting plasma glucose levels and etc. will also be performed.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2013

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

8.6 years

First QC Date

July 24, 2019

Last Update Submit

July 29, 2019

Conditions

SLEAtherosclerosis

Keywords

SLEAtherosclerosiscarotid intima media thicknessbrachial-ankle pulse wave velocityrisk factorsCohort

Outcome Measures

Primary Outcomes (1)

  • quantitative change in CIMT from baseline

    quantitative changes in CIMT at 5-year follow-up from baseline will be documented

    Year 5

Secondary Outcomes (2)

  • quantitative change in baPWV from baseline

    Year 5

  • Major cardiovascular events

    5 years

Interventions

CIMT and baPWV measurementDIAGNOSTIC_TEST

All patients will receive carotid intima media thickness (CIMT) and brachial-ankle pulse wave velocity (baPWV) measurement at baseline and 5-year follow-up.

Eligibility Criteria

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

The target population was patients with the clinical diagnosis of SLE. Study participants were recruited through a nationwide registry system created by the Chinese SLE Treatment and Research group. All patients were continuously enrolled as outpatients of the Department of Rheumatology in Peking Union Medical College Hospital (PUMCH), which is a renowned hospital in China.

You may qualify if:

  • Age≥18 years
  • Fulfillment of clinical classification criteria of SLE (four or more 1997 American College of Rheumatology classification criteria)
  • Provision of signed written informed consent

You may not qualify if:

  • Clinically overt coronary artery disease
  • A history of cardiovascular disease (previous stroke, heart failure, myocardial infarction, angina, or symptomatic PAD)
  • Malignancy
  • Pregnant/lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hostipal

Beijing, Beijing Municipality, 100010, China

Location

Related Publications (3)

  • Giannelou M, Mavragani CP. Cardiovascular disease in systemic lupus erythematosus: A comprehensive update. J Autoimmun. 2017 Aug;82:1-12. doi: 10.1016/j.jaut.2017.05.008. Epub 2017 Jun 9.

    PMID: 28606749BACKGROUND

  • Esdaile JM, Abrahamowicz M, Grodzicky T, Li Y, Panaritis C, du Berger R, Cote R, Grover SA, Fortin PR, Clarke AE, Senecal JL. Traditional Framingham risk factors fail to fully account for accelerated atherosclerosis in systemic lupus erythematosus. Arthritis Rheum. 2001 Oct;44(10):2331-7. doi: 10.1002/1529-0131(200110)44:103.0.co;2-i.

    PMID: 11665973BACKGROUND

  • Manzi S, Meilahn EN, Rairie JE, Conte CG, Medsger TA Jr, Jansen-McWilliams L, D'Agostino RB, Kuller LH. Age-specific incidence rates of myocardial infarction and angina in women with systemic lupus erythematosus: comparison with the Framingham Study. Am J Epidemiol. 1997 Mar 1;145(5):408-15. doi: 10.1093/oxfordjournals.aje.a009122.

    PMID: 9048514BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

1.5ml blood plasma will be retained from each patient

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Shuyang Zhang, MD

    Peking Union Medical College Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2019

First Posted

July 30, 2019

Study Start

May 1, 2013

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

July 31, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)