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SLEPASLENCT04037293

Premature Atherosclerosis in Systemic Lupus Erythematosus

An observational study of SLE and Atherosclerosis, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
SLE, Atherosclerosis
What is being tested?
CIMT and baPWV measurement
How many people
500 participants
Where
1 siteChina
Study dates
1 May 2013to Dec 2021
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hostipal

    Beijing, Beijing Municipality, 100010

Other trials in China

About this study

Official title: Premature Atherosclerosis in Systemic Lupus Erythematosus: a Prospective Cohort Study

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.

Conditions
SLE, Atherosclerosis
Being tested
CIMT and baPWV measurement
Keywords
SLE, Atherosclerosis, carotid intima media thickness, brachial-ankle pulse wave velocity, risk factors, Cohort
Medical subject headings
Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. quantitative change in CIMT from baseline

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

    Measured: Year 5

Secondary outcomes (2)

  1. quantitative change in baPWV from baseline

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

    Measured: Year 5

  2. Major cardiovascular events

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

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2019
  2. Study start1 May 2013
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04037293
Sponsor's protocol ID
JS-2057
Acronym
PASLE
Status last verified
Jul 2019
First submitted
24 Jul 2019
Last updated
31 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of SLE and Atherosclerosis, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

quantitative change in CIMT from baseline (time frame: Year 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04037293, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.

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