Risk Stratification Value of Biomarkers in Patients With Ventricular Arrhythmias

Ventricular Arrythmia Clinical Trial

— FUTURE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05965375
• Other study ID #: XJTU1AF2023LSK-171
• Status: Not yet recruiting
• Start date: December 31, 2024
• Est. completion date: May 31, 2027

Study information

• Verified date: April 2024
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Guoliang Li
• Phone: +8613759982523
• Email: liguoliang_med[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: May 31, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Ventricular Arrythmia

Intervention

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

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiantong University	Xi'an	Shaanxi

Sponsors (5)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	521 Hospital of NORINCO Group, Henan Provincial People's Hospital, Shaanxi Provincial People's Hospital, Xiangyang Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.