Risk Stratification Value of Biomarkers in Patients With Ventricular Arrhythmias (FUTURE)

Risk Stratification Value of Biomarkers in Patients With Ventricular Arrhythmias (FUTURE): an Investigator-initiated, National, Multicenter, Retrospective-prospective, Cohort Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ventricular Arrythmia
• Intervention / Treatment: Other: Observational; No Interventions were given.

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.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Guoliang Li; Phone Number: +8613759982523; Email: liguoliang_med@163.com
• Study Contact Backup: Name: Chaofeng Sun; Email: cfsun1@mail.xjtu.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • First Affiliated Hospital of Xian Jiantong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.; 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.; 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.; 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.; 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.; Observational; No Interventions were given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the incidence of myocardial infarction	Myocardial infarction diagnosed by clinical doctors will be assessed from the medical records.	3,6 months,1,3,5 years after enrollment.
Change in the incidence of stroke	Stroke diagnosed by clinical doctors will be assessed from the medical records.	3,6 months,1,3,5 years after enrollment.
Change in the incidence of vessel revascularization	Vessel revascularization assessed by clinical doctors will be assessed from the medical records.	3,6 months,1,3,5 years after enrollment.
Change in the incidence of all-cause death	All-cause death diagnosed by clinical doctors will be assessed from the medical records.	3,6 months,1,3,5 years after enrollment.

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: Shaanxi Provincial People's Hospital; Henan Provincial People's Hospital; 521 Hospital of NORINCO Group; Xiangyang Central Hospital
• Investigators: Principal Investigator: Guoliang Li, First Affiliated Hospital Xi'an Jiaotong University; Principal Investigator: Chaofeng Sun, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Estimated): December 31, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Prognosis; Ventricular Arrhythmia
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: XJTU1AF2023LSK-171

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No