Clinical trial NCT05965375: Risk Stratification Value of Biomarkers in Patients With Ventricular Arrhythmias
Official title: Risk Stratification Value of Biomarkers in Patients With Ventricular Arrhythmias (FUTURE): an Investigator-initiated, National, Multicenter, Retrospective-prospective, Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ventricular Arrythmia
Keywords: Ventricular Arrhythmia
Prognosis
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: 521 Hospital of NORINCO Group
name: Shaanxi Provincial People's Hospital
name: Xiangyang Central Hospital
name: Henan Provincial People's Hospital
First posted: 2023-07-28
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Primary outcomes:
measure: Change in the incidence of MACCE
timeFrame: 3,6 months,1,3,5 years after enrollment.
Secondary outcomes:
measure: Change in the incidence of myocardial infarction
timeFrame: 3,6 months,1,3,5 years after enrollment.
measure: Change in the incidence of stroke
timeFrame: 3,6 months,1,3,5 years after enrollment.
measure: Change in the incidence of vessel revascularization
timeFrame: 3,6 months,1,3,5 years after enrollment.
measure: Change in the incidence of all-cause death
timeFrame: 3,6 months,1,3,5 years after enrollment.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiantong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Guoliang Li
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Chaofeng Sun
role: PRINCIPAL_INVESTIGATOR
References: