PCSK9NCT05191342
Proprotein Convertase Subtilisin Kexin 9 in Rheumatoid Arthritis
An observational study of PCSK9, run by First Affiliated Hospital of Harbin Medical University at 2 sites in China.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- PCSK9
- What is being tested?
- Enzyme-linked immunosorbent assay for PCSK9
- How many people
- 75 participants
- Where
- 2 sitesChina
- Study dates
- 1 Nov 2021to 1 Nov 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Rheumatoid arthritis
- Rheumatoid arthritis combined with AF
Who cannot join
- 1. (1) History of hypertension, diabetes, cardiovascular disease, severe impairment of liver function, severe renal insufficiency.
- 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.
- Infectious diseases. (3) History malignant tumor. (4) Pregnant women, Lactating women. (5) Other autoimmune diseases.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
the first affiliated hospital of Harbin medical university
Harbin, Heilongjiang, 150001
Yue Li, PhD, 86-451-85552216, ly99ly@vip.163.com
- Recruiting
Thrombelastogram
Harbin, Heilongjiang, 150001
Meijiao He, Doctor, 86-451-85555672 ext. 0451-85555673, hemeijiao99@sina.com
Jing Shi, Doctor, 86-451-85555671 ext. 0451-85555673, yidashijing@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- PCSK9
- Being tested
- Enzyme-linked immunosorbent assay for PCSK9
- Keywords
- Atrial fibrillation, Rheumatoid arthritis, PCSK9
- Medical subject headings
- Atrial Fibrillation, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzyme-linked immunosorbent assay for PCSK9Diagnostic test
Enzyme-linked immunosorbent assay for plasma PCSK9
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis | Patients with rheumatoid arthritis (n=25). Receives: Diagnostic Test: Enzyme-linked immunosorbent assay for PCSK9 | |
| Rheumatoid arthritis complicated atrial fibrillation | Patients with rheumatoid arthritis complicated atrial fibrillation (n=25). Receives: Diagnostic Test: Enzyme-linked immunosorbent assay for PCSK9 | |
| healthy volunteers | Healthy volunteers (n=25). Receives: Diagnostic Test: Enzyme-linked immunosorbent assay for PCSK9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The expression of PCSK9 in patients with RA combined with AF
To assess the expression and significance of plasma PCSK9 in three groups.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Nov 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCSK9Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yue LI, First Affiliated Hospital of Harbin Medical University
- Investigators
- Yue Li, Doctor, Principal investigator, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191342
- Sponsor's protocol ID
- Atrial fibrillation and RA
- Status last verified
- Dec 2021
- First submitted
- 30 Dec 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Expression of Proprotein Convertase Subtilisin Kexin 9 in Patients With Rheumatoid Arthritis Combined Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05191342
- Acronym / sponsor ID
- Atrial fibrillation and RA
- Conditions
- PCSK9
- Keywords
- Atrial fibrillation, Rheumatoid arthritis, PCSK9
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis | – | Diagnostic Test: Enzyme-linked immunosorbent assay for PCSK9Patients with rheumatoid arthritis (n=25). |
| Rheumatoid arthritis complicated atrial fibrillation | – | Diagnostic Test: Enzyme-linked immunosorbent assay for PCSK9Patients with rheumatoid arthritis complicated atrial fibrillation (n=25). |
| healthy volunteers | – | Diagnostic Test: Enzyme-linked immunosorbent assay for PCSK9Healthy volunteers (n=25). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Rheumatoid arthritis
- Rheumatoid arthritis combined with AF
Key exclusion criteria (4 listed)
- 1. (1) History of hypertension, diabetes, cardiovascular disease, severe impairment of liver function, severe renal insufficiency.
- 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.
- Infectious diseases. (3) History malignant tumor. (4) Pregnant women, Lactating women. (5) Other autoimmune diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enzyme-linked immunosorbent assay for PCSK9Enzyme-linked immunosorbent assay for plasma PCSK9 | Diagnostic test | Rheumatoid arthritis, Rheumatoid arthritis complicated atrial fibrillation, healthy volunteers |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yue Li, Doctor principal investigator
First Affiliated Hospital of Harbin Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PCSK9, run by First Affiliated Hospital of Harbin Medical University at 2 sites 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 2 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 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Meijiao He, Doctor (86-451-85555673, hemeijiao99@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The expression of PCSK9 in patients with RA combined with AF (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2022; AzTrials last refreshed its copy on 7 Nov 2026.