Acute Cerebrovascular Events Secondary to Patients Receiving Cardiac Electronic Implants

Study Overview
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Brief Summary
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Objective: 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. Methods: 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.

Official Title
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Clinical Characteristics and Prognosis of Acute Cerebrovascular Events Secondary to Patients Receiving Cardiac Electronic Implants-A Multicenter Real-world Trial

Conditions
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Stroke, Atrial Fibrillation, Pacemaker

Intervention / Treatment
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* Device: cardiac electronic implants


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Clinical diagnosis of acute cerebrovascular disease secondary to cardiac electronic device implantation. 2.Hospitalized from January 2012 to September 2022. Exclusion Criteria: 1. Patients were absent of cranial CT/MRI scan data. 2. Patients refuse to take follow-up interviews.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ischemic stroke group<br>Ischemic stroke secondary to patients receiving cardiac electronic implants 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. | Device: cardiac electronic implants<br>* Cardiac electronic implants(CIED) includes permanent pacemaker (PPM), implantable cardioverter defibrillator (ICD), three-chamber pacemaker for cardiac resynchronization therapy defibrillator, lead free pacemaker, etc.<br>|
| Transient ischemic attack group<br>Transient ischemic attack secondary to patients receiving cardiac electronic implants 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. | Device: cardiac electronic implants<br>* Cardiac electronic implants(CIED) includes permanent pacemaker (PPM), implantable cardioverter defibrillator (ICD), three-chamber pacemaker for cardiac resynchronization therapy defibrillator, lead free pacemaker, etc.<br>|
| Cerebral hemorrhage group<br>Cerebral hemorrhage secondary to patients receiving cardiac electronic implants 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. | Device: cardiac electronic implants<br>* Cardiac electronic implants(CIED) includes permanent pacemaker (PPM), implantable cardioverter defibrillator (ICD), three-chamber pacemaker for cardiac resynchronization therapy defibrillator, lead free pacemaker, etc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of acute cerebrovascular disease | Number and rate of patients with acute cerebrovascular disease secondary to patients receiving cardiac electronic implants | up to 4 weeks in hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality | In-hospital mortality of acute cerebrovascular disease in patients receiving cardiac electronic implants | up to 4 weeks in hospital | 
| all-cause mortality | all-cause mortality within 3 months of telephone follow-up | 3 months |