StrokeSOS-CARENCT05623527
Clinical Characteristics and Prognosis of Acute Cerebrovascular Events Secondary to Patients Receiving Cardiac Electronic Implants
An observational study of Stroke and Atrial Fibrillation, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Atrial Fibrillation, Pacemaker
- What is being tested?
- cardiac electronic implants
- Type of treatment
- Medical device
- How many people
- 13,324 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2022to 30 Sep 2023
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: From January 2012 to September 2022, any patients with cardiac implantable electronic device
Who may be able to join
- Clinical diagnosis of acute cerebrovascular disease secondary to cardiac electronic device implantation.
- Hospitalized from January 2012 to September 2022.
Who cannot join
- Patients were absent of cranial CT/MRI scan data.
- Patients refuse to take follow-up interviews.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Characteristics and Prognosis of Acute Cerebrovascular Events Secondary to Patients Receiving Cardiac Electronic Implants (SOS-CARE) - A Multicenter Real-world Trial
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.
- Conditions
- Stroke, Atrial Fibrillation, Pacemaker
- Being tested
- cardiac electronic implants
- Medical subject headings
- Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac electronic implantsDevice
Cardiac electronic implants(CIED) includes permanent pacemaker (PPM), implantable cardioverter defibrillator (ICD), three-chamber pacemaker for cardiac resynchronization therapy defibrillator, lead free pacemaker, etc.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic stroke group | 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. Receives: Device: cardiac electronic implants | |
| Transient ischemic attack group | 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. Receives: Device: cardiac electronic implants | |
| Cerebral hemorrhage group | 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. Receives: Device: cardiac electronic implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of acute cerebrovascular disease
Number and rate of patients with acute cerebrovascular disease secondary to patients receiving cardiac electronic implants. The data were obtained from the medical records.
Measured: About 4 weeks after the enrollment
Secondary outcomes (2)
In-hospital mortality
In-hospital mortality of acute cerebrovascular disease in patients receiving cardiac electronic implants. The data were obtained from the medical records.
Measured: About 4 weeks after the enrollment
All-cause mortality
All-cause mortality within 3 months of telephone follow-up.
Measured: 3 months after the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start20 Nov 2022
- Primary completion31 Aug 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13,324 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guoliang Li, Principal investigator, Xi'an Jiaotong University First Affiliated Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623527
- Sponsor's protocol ID
- XJTU1AF2022LSK-408
- Acronym
- SOS-CARE
- Status last verified
- Oct 2023
- First submitted
- 27 Oct 2022
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided