Proprotein Convertase Subtilisin Kexin 9 in Rheumatoid Arthritis

PCSK9 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05191342
• Other study ID #: Atrial fibrillation and RA
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: December 2021
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: Meijiao He, Doctor
• Phone: 86-451-85555673
• Email: hemeijiao99[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• PCSK9

Intervention

Diagnostic Test:
• Enzyme-linked immunosorbent assay for PCSK9
Enzyme-linked immunosorbent assay for plasma PCSK9

Locations

Country	Name	City	State
China	the first affiliated hospital of Harbin medical university	Harbin	Heilongjiang
China	Thrombelastogram	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The expression of PCSK9 in patients with RA combined with AF	To assess the expression and significance of plasma PCSK9 in three groups.	One year