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OpenTrials
Completed

NCT Number: NCT05623527

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cardiac electronic implants

Device

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

Primary outcomes

  1. The incidence of acute cerebrovascular disease

    Time frame: 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 outcomes

  1. In-hospital mortality

    Time frame: 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.

  2. All-cause mortality

    Time frame: 3 months after the enrollment

    All-cause mortality within 3 months of telephone follow-up.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

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

Acronym: SOS-CARE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 21, 2022
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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