PASLE: Premature Atherosclerosis in Systemic Lupus Erythematosus

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04037293

Collaborator

Beijing Municipal Science & Technology Commission (Other), National Natural Science Foundation of China (Other)

500

Enrollment

Location

103

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SLE Atherosclerosis	Diagnostic Test: CIMT and baPWV measurement

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Premature Atherosclerosis in Systemic Lupus Erythematosus: a Prospective Cohort Study

Actual Study Start Date :

May 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Outcome Measures

Primary Outcome Measures

quantitative change in CIMT from baseline [Year 5]
quantitative changes in CIMT at 5-year follow-up from baseline will be documented

Secondary Outcome Measures

quantitative change in baPWV from baseline [Year 5]
quantitative changes in baPWV at 5-year follow-up from baseline will be documented
Major cardiovascular events [5 years]
the prevalence rate of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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