Proprotein Convertase Subtilisin Kexin 9 in Rheumatoid Arthritis

December 30, 2021 updated by: Yue LI, First Affiliated Hospital of Harbin Medical University

The Expression of Proprotein Convertase Subtilisin Kexin 9 in Patients With Rheumatoid Arthritis Combined Atrial Fibrillation

Rheumatoid arthritis (RA) has been proved to increase the incidence of atrial fibrillation (AF) with persistent systemic inflammation. Proprotein convertase subtilisin/kexin type 9 (PCSK9) has been found to enhance the production of pro-inflammatory cytokines. Therefore, we performed the present study to observe the expression and significance of proprotein convertase subtilisin kexin 9 (PCSK9) in patients with RA combined atrial fibrillation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Atrial fibrillation (AF), the most common clinically relevant arrhythmia, is an important contributor to population morbidity and mortality. Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease, which affects approximately 1% of the population. Increasing studies demonstrated that RA had a positive correlation with increased cardiovascular diseases. Increasing studies showed that the prevalence of AF is significantly higher in RA patients than in the general population. Recently, some studies indicated that proprotein convertase subtilisin/kexin type 9 (PCSK9) promotes inflammatory by regulating macrophage secretion of inflammatory cytokines, inducing C-reaction protein (CRP), interleukin (IL)-6, IL-8, tumor necrosis factor-α (TNF-α) and so on. However, the levels of PCSK9 in atrial fibrillation patients with rheumatoid arthritis is still unclear. Therefore, the aim of this study was to assess the expression of PCSK9 in patients with RA combined atrial fibrillation.

Study Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Recruiting
        • The First Affiliated Hospital of Harbin Medical University
        • Contact:
      • Harbin, Heilongjiang, China, 150001
        • Recruiting
        • Thrombelastogram
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with rheumatoid arthritis (n=25), patients with rheumatoid arthritis complicated atrial fibrillation (n=25) and healthy volunteers (n=25). ELISA were used to test plasma PCSK9.

Description

Inclusion Criteria:

  1. Rheumatoid arthritis
  2. Rheumatoid arthritis combined with AF

Exclusion Criteria:

1. (1) History of hypertension, diabetes, cardiovascular disease, severe impairment of liver function, severe renal insufficiency.

(2) Infectious diseases. (3) History malignant tumor. (4) Pregnant women, Lactating women. (5) Other autoimmune diseases.

2. (1) History of hypertension, diabetes, cardiovascular disease (except for AF), severe impairment of liver function, severe renal insufficiency.

(2) Infectious diseases. (3) History malignant tumor. (4) Pregnant women, Lactating women. (5) Other autoimmune diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rheumatoid arthritis
Patients with rheumatoid arthritis (n=25).
Diagnostic test: Enzyme-linked immunosorbent assay for PCSK9
Enzyme-linked immunosorbent assay for plasma PCSK9
Rheumatoid arthritis complicated atrial fibrillation
Patients with rheumatoid arthritis complicated atrial fibrillation (n=25).
Diagnostic test: Enzyme-linked immunosorbent assay for PCSK9
Enzyme-linked immunosorbent assay for plasma PCSK9
healthy volunteers
Healthy volunteers (n=25).
Diagnostic test: Enzyme-linked immunosorbent assay for PCSK9
Enzyme-linked immunosorbent assay for plasma PCSK9

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The expression of PCSK9 in patients with RA combined with AF
Time Frame: One year
To assess the expression and significance of plasma PCSK9 in three groups.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Harbin Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

December 30, 2021

First Submitted That Met QC Criteria

December 30, 2021

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Actual)

January 13, 2022

Last Update Submitted That Met QC Criteria

December 30, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Atrial fibrillation and RA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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