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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital Xi'an Jiaotong University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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