Risk Stratification Value of Biomarkers in Patients With Ventricular Arrhythmias

NCT ID: NCT05965375

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2027-05-31

Brief Summary

The investigation of biomarkers for immune status and metabolic state, as well as host microbiota composition, in patients with ventricular arrhythmias before and after radiofrequency ablation, can provide new insights for specific and personalized treatment. This can help establish early prediction and prognosis models and provide a basis for clinically effective diagnosis and treatment.

Detailed Description

Abnormal immune and metabolic states can lead to the occurrence of various systemic diseases, including the development of cardiovascular diseases through multiple mechanisms. On the other hand, various diseases can also feedback and regulate the immune and metabolic systems. However, currently there is no research on the impact of immune and metabolic states on ventricular arrhythmia. Exploring the biomarker characteristics and risk stratification of patients with ventricular arrhythmias undergoing radiofrequency ablation before and after the procedure can provide new insights for specific and personalized treatment. It can establish early prediction and prognostic models, providing evidence for clinically effective diagnosis and treatment.

Conditions

Ventricular Arrythmia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Occasional premature ventricular contractions group

Premature ventricular contractions (PVCs) occur when an electrical impulse originates from an ectopic focus within the ventricle or the interventricular septum, causing premature depolarization of the ventricle before the impulse from the sinoatrial node has reached the ventricle. Occasional PVCs refer to PVCs that occur less than 6 times per minute.

Observational; No Interventions were given.

Intervention Type: OTHER

Observational; No Interventions were given.

Frequent premature ventricular contractions group

Premature ventricular contractions (PVCs) occur when an electrical impulse originates from an ectopic focus within the ventricle or the interventricular septum, causing premature depolarization of the ventricle before the impulse from the sinoatrial node has reached the ventricle. Frequent PVCs refer to PVCs that occur more than 6 times per minute.

Observational; No Interventions were given.

Intervention Type: OTHER

Observational; No Interventions were given.

Short runs of ventricular tachycardia group

Premature ventricular contractions (PVCs) occur when an electrical impulse originates from an ectopic focus within the ventricle or the interventricular septum, causing premature depolarization of the ventricle before the impulse from the sinoatrial node has reached the ventricle. Short runs of ventricular tachycardia refer to three or more consecutive PVCs that occur within 30 seconds.

Observational; No Interventions were given.

Intervention Type: OTHER

Observational; No Interventions were given.

Sustained ventricular tachycardia group

Sustained ventricular tachycardia (VT) is defined as ventricular arrhythmia that lasts for at least 30 seconds and has a heart rate exceeding 100 bpm, or requires termination before 30 seconds due to hemodynamic instability.

Observational; No Interventions were given.

Intervention Type: OTHER

Observational; No Interventions were given.

Ventricular fibrillation group

Ventricular fibrillation refers to the complete disappearance of QRS waves, ST segments, and T waves in the ECG, replaced by different shapes, varying amplitudes, and extremely irregular ventricular fibrillation waves.

Observational; No Interventions were given.

Intervention Type: OTHER

Observational; No Interventions were given.

Interventions

Observational; No Interventions were given.

Observational; No Interventions were given.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with ventricular premature beats, ventricular tachycardia, or ventricular fibrillation detected by regular surface twelve-lead electrocardiogram or Holter.

Exclusion Criteria

• Age <18 or >80 years old;
• Patients with autoimmune diseases or immune deficiencies, or those who have used immunosuppressive or immune modulating agents in the past 3 months;
• Platelet count <100×10^9/L or functional platelet defects;
• Congenital or acquired coagulation or bleeding disorders;
• Patients with a history of organ transplantation or are preparing to receive organ transplantation;
• Unwilling to sign an informed consent or cooperate with the examination.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

521 Hospital of NORINCO Group

OTHER

Sponsor Role: collaborator

Shaanxi Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Xiangyang Central Hospital

OTHER

Sponsor Role: collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guoliang Li

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Chaofeng Sun

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

First Affiliated Hospital of Xian Jiantong University

Xi'an, Shaanxi, China

Countries

China

Central Contacts

Guoliang Li

Role: CONTACT

liguoliang_med@163.com

+8613759982523

Chaofeng Sun

Role: CONTACT

cfsun1@mail.xjtu.edu.cn

Other Identifiers

XJTU1AF2023LSK-171

Identifier Type: -

Identifier Source: org_study_id