Acute Cerebrovascular Events in Patients Undergoing Catheter Ablation

NCT05694273 | Not Yet Recruiting

• 1 other identifier: XJTU1AF2023LSK-531
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Arrhythmia; Acute Cerebrovascular Disease

Keywords

Catheter ablation; Arrhythmia; Major adverse cardiovascular and cerebrovascular events (MACCE)

Outcome Measures

Primary Outcomes (1)

• Incidence of MACCE

  Major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, myocardial infarction and stroke. The data will be obtained at 3-month follow-up, according to medical records of all patients.

  3 months after enrollment

Secondary Outcomes (3)

• Incidence of all-cause mortality

  3 months after enrollment

• Incidence of myocardial infarction

  3 months after enrollment

• Incidence of stroke

  3 months after enrollment

Study Arms (4)

Ischemic stroke group

1. Ischemic stroke secondary to patients receiving catheter ablation. 2. Ischemic stroke met the diagnostic criteria of the 2018 edition of the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke, and was confirmed by cranial CT/MRI scan.

Transient ischemic attack group

1. Transient ischemic attack secondary to patients receiving catheter ablation. 2. Ischemic stroke met the diagnostic criteria of the 2018 edition of the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke, and was confirmed negative of new onset of infarction by cranial CT/MRI scan.

Cerebral hemorrhage group

1. Cerebral hemorrhage secondary to patients receiving catheter ablation. 2. Cerebral hemorrhage met the diagnostic criteria of the 2021 Chinese Guidelines for the Diagnosis and Treatment of cerebral hemorrhage and was confirmed by head CT/MRI.

Contral group

Patients who did not experience acute cerebrovascular events in the hospital.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who undergo catheter ablation for arrhythmias.

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Shaanxi Provincial People's Hospital: collaborator
• 521 Hospital of NORINCO Group: collaborator
• Xiangyang Central Hospital: collaborator
• Ankang Central Hospital: collaborator
• Baoji Central Hospital: collaborator
• Luoyang Central Hospital: collaborator
• Tianjin Medical University Second Hospital: collaborator
• Fu Wai Hospital, Beijing, China: collaborator
• Fuwai Yunnan Cardiovascular Hospital: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator

Study Sites (1)

First Affiliated Hospital of Xian Jiantong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guoliang Li

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoliang li

CONTACT

+8613759982523; liguoliang_med@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 23, 2023
• Study Start: January 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 4, 2024

Record last verified: 2024-03

Locations

CN (1)