Premature Atherosclerosis in Systemic Lupus Erythematosus

Atherosclerosis Clinical Trial

— PASLE  

Official title:

Premature Atherosclerosis in Systemic Lupus Erythematosus: a Prospective Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04037293
• Other study ID #: JS-2057
• Status: Active, not recruiting
• Start date: May 1, 2013
• Est. completion date: December 2021

Study information

• Verified date: July 2019
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Lupus Erythematosus, Systemic
• SLE

Intervention

Diagnostic Test:
• CIMT 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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hostipal	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Beijing Municipal Science & Technology Commission, National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

References & Publications (3)

Esdaile JM, Abrahamowicz M, Grodzicky T, Li Y, Panaritis C, du Berger R, Côte R, Grover SA, Fortin PR, Clarke AE, Senécal JL. Traditional Framingham risk factors fail to fully account for accelerated atherosclerosis in systemic lupus erythematosus. Arthritis Rheum. 2001 Oct;44(10):2331-7. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quantitative change in CIMT from baseline	quantitative changes in CIMT at 5-year follow-up from baseline will be documented	Year 5
Secondary	quantitative change in baPWV from baseline	quantitative changes in baPWV at 5-year follow-up from baseline will be documented	Year 5
Secondary	Major cardiovascular events	the prevalence rate of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death	5 years