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NCT Number: NCT05965375

Risk Stratification Value of Biomarkers in Patients With Ventricular Arrhythmias

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Xian Jiantong University

Xi'an, Shaanxi, 710061, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational; No Interventions were given.

Other

Observational; No Interventions were given.

Primary outcomes

  1. Change in the incidence of MACCE

    Time frame: 3,6 months,1,3,5 years after enrollment.

    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.

Secondary outcomes

  1. Change in the incidence of myocardial infarction

    Time frame: 3,6 months,1,3,5 years after enrollment.

    Myocardial infarction diagnosed by clinical doctors will be assessed from the medical records.

  2. Change in the incidence of stroke

    Time frame: 3,6 months,1,3,5 years after enrollment.

    Stroke diagnosed by clinical doctors will be assessed from the medical records.

  3. Change in the incidence of vessel revascularization

    Time frame: 3,6 months,1,3,5 years after enrollment.

    Vessel revascularization assessed by clinical doctors will be assessed from the medical records.

  4. Change in the incidence of all-cause death

    Time frame: 3,6 months,1,3,5 years after enrollment.

    All-cause death diagnosed by clinical doctors will be assessed from the medical records.

Study contacts

Contact information is provided by the study sponsor or research team.

Chaofeng Sun

CONTACT

[email protected]

Guoliang Li

CONTACT

[email protected]

+8613759982523

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Collaborators

  • 521 Hospital of NORINCO Group
  • Henan Provincial People's Hospital
  • Shaanxi Provincial People's Hospital
  • Xiangyang Central Hospital

Registry information

Official study title

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

Acronym: FUTURE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2023
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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