Acute Cerebrovascular Events in Patients Undergoing Catheter Ablation (CENTRAL)

April 2, 2024 updated by: First Affiliated Hospital Xi'an Jiaotong University

Acute Cerebrovascular Events in Patients Undergoing Catheter Ablation (CENTRAL): an Investigator-initiated, Multicenter Real-world Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • First Affiliated Hospital of Xian Jiantong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of MACCE
Time Frame: 3 months after enrollment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of all-cause mortality
Time Frame: 3 months after enrollment
The data will be obtained at 3-month follow-up, according to medical records of all patients.
3 months after enrollment
Incidence of myocardial infarction
Time Frame: 3 months after enrollment
The data will be obtained at 3-month follow-up, according to medical records of all patients.
3 months after enrollment
Incidence of stroke
Time Frame: 3 months after enrollment
The data will be obtained at 3-month follow-up, according to medical records of all patients.
3 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Collaborators

Shaanxi Provincial People's Hospital
Chinese Academy of Medical Sciences, Fuwai Hospital
Tianjin Medical University Second Hospital
Fu Wai Hospital, Beijing, China
Baoji Central Hospital
521 Hospital of NORINCO Group
Luoyang Central Hospital
Ankang Central Hospital
Xiangyang Central Hospital
Fuwai Yunnan Cardiovascular Hospital

Investigators

  • Principal Investigator: Guoliang Li, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2023LSK-531

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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