Acute Cerebrovascular Events Secondary to Patients Receiving Cardiac Electronic Implants

Stroke Clinical Trial

— SOS-CARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05623527
• Other study ID #: XJTU1AF2022LSK-408
• Status: Recruiting
• Start date: November 20, 2022
• Est. completion date: December 28, 2023

Study information

• Verified date: October 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: guoliang li
• Phone: +8613759982523
• Email: lgl[@]xjtufh.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 28, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Pacemaker
• Stroke

Intervention

Device:
• cardiac electronic implants
Cardiac electronic implants(CIED) includes permanent pacemaker (PPM), implantable cardioverter defibrillator (ICD), three-chamber pacemaker for cardiac resynchronization therapy defibrillator, lead free pacemaker, etc.

Locations

Country	Name	City	State
China	Guoliang Li	Xi'an	Shannxi Province

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	In-hospital mortality	In-hospital mortality of acute cerebrovascular disease in patients receiving cardiac electronic implants	up to 4 weeks in hospital
Secondary	all-cause mortality	all-cause mortality within 3 months of telephone follow-up	3 months