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Not yet recruiting NCT05965375

Risk Stratification Value of Biomarkers in Patients With Ventricular Arrhythmias

Observational Ventricular Arrythmia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational; No Interventions were given..
Who it may be relevant to
Registry conditions: Ventricular Arrythmia. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other Observational; No Interventions were given.
    Observational; No Interventions were given.

Primary outcome measures

  • Change in the incidence of MACCE [Time frame: 3,6 months,1,3,5 years after enrollment.]
Secondary outcome measures (4)
  • Change in the incidence of myocardial infarction [Time frame: 3,6 months,1,3,5 years after enrollment.]
  • Change in the incidence of stroke [Time frame: 3,6 months,1,3,5 years after enrollment.]
  • Change in the incidence of vessel revascularization [Time frame: 3,6 months,1,3,5 years after enrollment.]
  • Change in the incidence of all-cause death [Time frame: 3,6 months,1,3,5 years after enrollment.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • First Affiliated Hospital of Xian Jiantong University — Xi'an

Identifiers

NCT: NCT05965375 · XJTU1AF2023LSK-171

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗