NCT05191342

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

January 13, 2022

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

December 30, 2021

Last Update Submit

December 30, 2021

Conditions

PCSK9

Keywords

Atrial fibrillationRheumatoid arthritisPCSK9

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Rheumatoid arthritis

Patients with rheumatoid arthritis (n=25).

Diagnostic Test: Enzyme-linked immunosorbent assay for PCSK9

Rheumatoid arthritis complicated atrial fibrillation

Patients with rheumatoid arthritis complicated atrial fibrillation (n=25).

Diagnostic Test: Enzyme-linked immunosorbent assay for PCSK9

healthy volunteers

Healthy volunteers (n=25).

Diagnostic Test: Enzyme-linked immunosorbent assay for PCSK9

Interventions

Enzyme-linked immunosorbent assay for PCSK9DIAGNOSTIC_TEST

Enzyme-linked immunosorbent assay for plasma PCSK9

Rheumatoid arthritisRheumatoid arthritis complicated atrial fibrillationhealthy volunteers

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Rheumatoid arthritis
  • Rheumatoid arthritis combined with AF

You may not qualify if:

  • \. (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.
  • \. (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

the first affiliated hospital of Harbin medical university

Harbin, Heilongjiang, 150001, China

RECRUITING

Thrombelastogram

Harbin, Heilongjiang, 150001, China

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Yue Li, Doctor

    First Affiliated Hospital of Harbin Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meijiao He, Doctor

CONTACT

86-451-85555673hemeijiao99@sina.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 30, 2021

First Posted

January 13, 2022

Study Start

November 1, 2021

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

January 13, 2022

Record last verified: 2021-12

Locations

CN(2)