The Mechanism of Endogenous Nociceptin/Orphanin FQ(N/OFQ) and β1-adrenoceptor Autoantibody in Promoting Ischemic Arrhythmia in Rats

NCT ID: NCT06947551

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In the early stage of ischemic arrhythmia, endogenous N/OFQ regulates the expression of β 1-AA, mediates the internalization of β 1-AR by PKC/ERK1/2, and thus affects the occurrence of arrhythmia. Further clarify the regulatory mechanism of N/OFQ on β 1-AR internalization and arrhythmia, providing experimental basis for drug development and target exploration of clinical ischemic arrhythmia; To observe the relationship between endogenous N/OFQ and β 1-AA in serum of patients with coronary heart disease and diabetes.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This project mainly involves animal experiments and cell experiments. The part of clinical trials involved is the extraction of autoantibodies to β 1-adrenoceptor (β 1-AA) from the serum of patients with coronary heart disease and diabetes. The purified antibodies are intended to be used as agonists to rapidly increase the concentration of β 1-AA in the body of animals and the environment of cells in a short time, observe the impact of the antibodies on animals and cells, and further clarify that β 1-AA affects the internalization of β 1-AR through PKC/ERK1/2 at the early stage of blood arrhythmia, so as to regulate the occurrence of arrhythmia. After reviewing the literature, we found that β 1-AA exists in patients with ischemic arrhythmia, coronary heart disease, dilated cardiomyopathy, heart failure, diabetes, dogs with dilated heart disease and hypertensive rats. These β 1-AA targets the second extracellular ring of β 1-AR. Moreover, it can produce an agonist like response to spontaneously beating rat cardiomyocytes, inducing ventricular arrhythmias by stimulating β 1-AR and its downstream pathways. This experiment plans to select 60 patients and extract 8ml and 4ml of blood from the elbow vein for centrifugation and serum extraction. β 1-AA will be separated and extracted using a chromatography column; 4ml is used to detect endogenous N/OFQ and β 1-AA levels using an ELISA kit.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myocardial Ischemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with coronary heart disease or diabetes under different course of disease

Select patients with coronary heart disease and diabetes who meet the standard, take 8ml of blood from the elbow vein, 4ml of blood for centrifugation, take serum, and use chromatography column to separate and extract β 1-AA; 4ml is used to detect endogenous N/OFQ and β 1-AA levels using an ELISA kit.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Inclusion Criteria:1) Inclusion criteria for patients with diabetes: refer to the diagnostic criteria for type 2 diabetes (T2DM) in the Chinese Guidelines for the Prevention and Treatment of Type 2 diabetes (2017) 2) Inclusion criteria for patients with coronary heart disease: patients with clinically diagnosed coronary heart disease according to the 1979 WHO Diagnostic Criteria for Ischemic Heart Disease, and exclusion criteria include heart failure, tumor, immune disease and diabetes. -

Exclusion Criteria:Exclusion criteria for patients with coronary heart disease: including heart failure, tumor, immune disease and diabetes. -
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Second Hospital of Shanxi Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zheng Guo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

yi Han

Role: STUDY_DIRECTOR

Second Hospital of Shanxi Medical University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

xinyu shang

Role: CONTACT

18451655670

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HY20240410

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.