Clinical Characteristics and Prognosis of Acute Cerebrovascular Events Secondary to Patients Receiving Cardiac Electronic Implants

Completed

• Conditions: Atrial Fibrillation; Pacemaker; Stroke
• Interventions: Device: cardiac electronic implants

• Registration Number: NCT05623527
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

To investigate the incidence, clinical characteristics and prognosis of acute ischemic and hemorrhagic cerebrovascular disease secondary to the implantation of cardiovascular implantable electronic devices, so as to provide a basis for subsequent treatment strategies and risk factor stratification.

This study intends to retrospectively collect the incidence and case characteristics of acute cerebral infarction, cerebral embolism, transient ischemic attack and cerebral hemorrhage in CIED patients admitted to the First Affiliated Hospital of Xi 'an Jiaotong University and other centers from January 2012 to September 2022. Then, the incidence of poor prognosis and related factors of patients within 3 months were followed up by telephone to provide a basis for subsequent treatment strategy and risk factor stratification.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2022-11-13
• Study Start: 2022-11-20
• Study First Posted: 2022-11-21
• Primary Completion: 2023-08-31
• Study Completion: 2023-09-30
• Status Verified: 2023-10
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13324

Inclusion Criteria

• Clinical diagnosis of acute cerebrovascular disease secondary to cardiac electronic device implantation.
• Hospitalized from January 2012 to September 2022.

Exclusion Criteria

• Patients were absent of cranial CT/MRI scan data.
• Patients refuse to take follow-up interviews.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ischemic stroke group	cardiac electronic implants	1. Ischemic stroke secondary to patients receiving cardiac electronic implants 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	cardiac electronic implants	1. Transient ischemic attack secondary to patients receiving cardiac electronic implants 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	cardiac electronic implants	1. Cerebral hemorrhage secondary to patients receiving cardiac electronic implants 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.

Primary Outcome Measures

Name	Time	Method
The incidence of acute cerebrovascular disease	About 4 weeks after the enrollment	Number and rate of patients with acute cerebrovascular disease secondary to patients receiving cardiac electronic implants. The data were obtained from the medical records.

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	3 months after the enrollment	All-cause mortality within 3 months of telephone follow-up.
In-hospital mortality	About 4 weeks after the enrollment	In-hospital mortality of acute cerebrovascular disease in patients receiving cardiac electronic implants. The data were obtained from the medical records.

Trial Locations

Locations (1)

Guoliang Li; 🇨🇳 Xi'an, Shannxi Province, China