Risk Stratification Value of Biomarkers in Patients With Ventricular Arrhythmias

NCT05965375 | Not Yet Recruiting

• 1 other identifier: XJTU1AF2023LSK-171
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Arrythmia

Keywords

Ventricular Arrhythmia; Prognosis

Outcome Measures

Primary Outcomes (1)

• Change in the incidence of MACCE

  Major adverse cardiovascular and cerebrovascular events, including myocardial infarction, stroke, vessel revascularization and all-cause death. The MACCE will be assessed from the medical records.

  3,6 months,1,3,5 years after enrollment.

Secondary Outcomes (4)

• Change in the incidence of myocardial infarction

  3,6 months,1,3,5 years after enrollment.

• Change in the incidence of stroke

  3,6 months,1,3,5 years after enrollment.

• Change in the incidence of vessel revascularization

  3,6 months,1,3,5 years after enrollment.

• Change in the incidence of all-cause death

  3,6 months,1,3,5 years after enrollment.

Study Arms (5)

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.

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.

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.

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.

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.

Other: Observational; No Interventions were given.

Interventions

Observational; No Interventions were given. OTHER

Observational; No Interventions were given.

Frequent premature ventricular contractions group; Occasional premature ventricular contractions group; Short runs of ventricular tachycardia group; Sustained ventricular tachycardia group; Ventricular fibrillation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• 521 Hospital of NORINCO Group: collaborator
• Shaanxi Provincial People's Hospital: collaborator
• Xiangyang Central Hospital: collaborator
• Henan Provincial People's Hospital: collaborator

Study Sites (1)

First Affiliated Hospital of Xian Jiantong University

Xi'an, Shaanxi, 710061, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, feces and urine.

Study Officials

• Guoliang Li

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

• Chaofeng Sun

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoliang Li

CONTACT

+8613759982523; liguoliang_med@163.com

Chaofeng Sun

CONTACT

cfsun1@mail.xjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 28, 2023
• Study Start: December 31, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

CN (1)