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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05965375
Other study ID # XJTU1AF2023LSK-171
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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