Clinical trial NCT05694273: Acute Cerebrovascular Events in Patients Undergoing Catheter Ablation
Official title: Acute Cerebrovascular Events in Patients Undergoing Catheter Ablation (CENTRAL): an Investigator-initiated, Multicenter Real-world Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Arrhythmia
Acute Cerebrovascular Disease
Keywords: Catheter ablation
Arrhythmia
Major adverse cardiovascular and cerebrovascular events (MACCE)
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Shaanxi Provincial People's Hospital
name: 521 Hospital of NORINCO Group
name: Xiangyang Central Hospital
name: Ankang Central Hospital
name: Baoji Central Hospital
name: Luoyang Central Hospital
name: Tianjin Medical University Second Hospital
name: Fu Wai Hospital, Beijing, China
name: Fuwai Yunnan Cardiovascular Hospital
name: Chinese Academy of Medical Sciences, Fuwai Hospital
First posted: 2023-01-23
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study plans to enroll patients with arrhythmias who undergo catheter ablation and meet the specified inclusion and exclusion criteria.

Brief summary: This study aims to evaluate the incidence, clinical characteristics, and short-term prognosis of acute cerebrovascular events occurring in-hospital in patients with arrhythmias following catheter ablation. The goal is to provide evidence supporting the improvement of patient quality of life and reduction of in-hospital acute cerebrovascular complications in patients with post-ablation arrhythmias. This will also contribute to the evidence-based clinical management of such patients.

Detailed description: With the steady development of catheter ablation, it has gradually become the main treatment of various arrhythmias. Antithrombotic and anticoagulant therapy after catheter ablation determines the occurrence of perioperative bleeding and ischemic events. However, the incidence, characteristics and short-term prognosis of secondary acute cerebrovascular events in patients with arrhythmia after catheter ablation have not been studied. Methods: This study was intended to retrospectively collect and analyze the case data and auxiliary examination results of patients with arrhythmia who underwent catheter ablation. To evaluate the incidence, clinical features and short-term prognosis of secondary acute ischemic and hemorrhagic cerebrovascular events in patients with arrhythmia after catheter ablation. In order to improve the quality of life of patients, reduce the secondary acute cerebrovascular complications in the hospital in patients with arrhythmia after catheter ablation, to provide evidence for promoting the clinical management of such patients, and to provide help for the maximum degree of prevention and control risk.

Eligibility criteria: Inclusion Criteria:

* 1.Patients who undergo catheter ablation for arrhythmias.

Exclusion Criteria:

* 1. Patients were diagnosed of acute cerebrovascular disease prior to radiofrequency catheter ablation;
* 2. Patients \< 18 years or \> 80 years;
* 3. Patients with uncomplete clinical data.

Primary outcomes:
measure: Incidence of MACCE
timeFrame: 3 months after enrollment
Secondary outcomes:
measure: Incidence of all-cause mortality
timeFrame: 3 months after enrollment
measure: Incidence of myocardial infarction
timeFrame: 3 months after enrollment
measure: Incidence of stroke
timeFrame: 3 months 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
References: