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Status unknownNCT04037293PASLEUpdated Jul 31, 2019

Premature Atherosclerosis in Systemic Lupus Erythematosus

An observational study in SLE and Atherosclerosis, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-31.

Sponsored by Peking Union Medical College Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

Accelerated atherosclerosis is a major complication of systemic lupus erythematosus (SLE), and it leads to increased cardiovascular morbidity and mortality in patients with SLE. Prevention and intervention of premature atherosclerosis is beneficial for prognosis and survival of patients with SLE.

The primary aim of this study was to investigate the natural progress of carotid intima media thickness (CIMT) in 5 years, and examine the risk factors for progression of CIMT and atherosclerotic plaques based on a Chinese SLE cohort. The secondary aims of the study were to investigate progression of brachial-ankle pulse wave velocity (baPWV), and to examine the risk factors for increasing baPWV in patients with SLE.

Based on sample size calculation, 440 patients who meet the eligibility criteria will be enrolled in this study. All patients will be enrolled from Peking Union Medical College Hospital. After informed consent is obtained, the patients will be comprehensively evaluated from demographic characteristics, medical history, clinical assessments, laboratory tests results, CIMT and baPWV at baseline and 5-year follow-up. Descriptive analysis, univariate analysis, and multivariate analysis will be used to analyze the correlation between potential risk factors and CIMT/baPWV.

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Conditions studied

  • SLE
  • Atherosclerosis

Keywords

  • SLE
  • Atherosclerosis
  • carotid intima media thickness
  • brachial-ankle pulse wave velocity
  • risk factors
  • Cohort
03

In context

Atherosclerosis

1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.

This study's enrollment of 500 is above the median of 223 across 571 observational studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (actual)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Interventions

  • Diagnostic testCIMT and baPWV measurement

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

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What researchers measure

Primary outcomes

  1. quantitative change in CIMT from baseline

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

    Time frame: Year 5

Secondary outcomes

  1. quantitative change in baPWV from baseline

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

    Time frame: Year 5

  2. Major cardiovascular events

    the prevalence rate of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death

    Time frame: 5 years

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Study locations

1 site
  • Peking Union Medical College Hostipal
    Beijing, Beijing 100010, China
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References and documents

Publications

  • 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. PubMed 28606749 ↗
  • 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. PubMed 11665973 ↗
  • 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. PubMed 9048514 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04037293
Lead sponsor
Peking Union Medical College Hospital
Collaborators
Beijing Municipal Science & Technology Commission, National Natural Science Foundation of China
Responsible party
Sponsor
First posted
Jul 30, 2019
Start date
May 1, 2013
Primary completion
Dec 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Jul 31, 2019

Study contacts

Shuyang Zhang, MD
study chair · Peking Union Medical College Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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