ArrhythmiaCENTRALNCT05694273
Acute Cerebrovascular Events in Patients Undergoing Catheter Ablation
An observational study of Arrhythmia and Acute Cerebrovascular Disease, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
This study aims to evaluate the incidence, clinical characteristics, and short-term prognosis of acute cerebrovascular events occurring in-hospital in patients with arrhythmias following catheter ablation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arrhythmia, Acute Cerebrovascular Disease
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study plans to enroll patients with arrhythmias who undergo catheter ablation and meet the specified inclusion and exclusion criteria.
Who may be able to join
- 1.Patients who undergo catheter ablation for arrhythmias.
Who cannot join
- 1. Patients were diagnosed of acute cerebrovascular disease prior to radiofrequency catheter ablation;
- 2. Patients < 18 years or > 80 years;
- 3. Patients with uncomplete clinical data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
First Affiliated Hospital of Xian Jiantong University
Xi'an, Shaanxi, 710061
Guoliang Li, 008613759982523, liguoliang_med@163.com
About this study
Official title: Acute Cerebrovascular Events in Patients Undergoing Catheter Ablation (CENTRAL): an Investigator-initiated, Multicenter Real-world Study
This study aims to evaluate the incidence, clinical characteristics, and short-term prognosis of acute cerebrovascular events occurring in-hospital in patients with arrhythmias following catheter ablation. The goal is to provide evidence supporting the improvement of patient quality of life and reduction of in-hospital acute cerebrovascular complications in patients with post-ablation arrhythmias. This will also contribute to the evidence-based clinical management of such patients.
Read the detailed description
With the steady development of catheter ablation, it has gradually become the main treatment of various arrhythmias. Antithrombotic and anticoagulant therapy after catheter ablation determines the occurrence of perioperative bleeding and ischemic events. However, the incidence, characteristics and short-term prognosis of secondary acute cerebrovascular events in patients with arrhythmia after catheter ablation have not been studied. Methods: This study was intended to retrospectively collect and analyze the case data and auxiliary examination results of patients with arrhythmia who underwent catheter ablation. To evaluate the incidence, clinical features and short-term prognosis of secondary acute ischemic and hemorrhagic cerebrovascular events in patients with arrhythmia after catheter ablation. In order to improve the quality of life of patients, reduce the secondary acute cerebrovascular complications in the hospital in patients with arrhythmia after catheter ablation, to provide evidence for promoting the clinical management of such patients, and to provide help for the maximum degree of prevention and control risk.
- Conditions
- Arrhythmia, Acute Cerebrovascular Disease
- Keywords
- Catheter ablation, Arrhythmia, Major adverse cardiovascular and cerebrovascular events (MACCE)
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic stroke group | 1. Ischemic stroke secondary to patients receiving catheter ablation. 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 | 1. Transient ischemic attack secondary to patients receiving catheter ablation. 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 | 1. Cerebral hemorrhage secondary to patients receiving catheter ablation. 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. | |
| Contral group | Patients who did not experience acute cerebrovascular events in the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of MACCE
Major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, myocardial infarction and stroke. The data will be obtained at 3-month follow-up, according to medical records of all patients.
Measured: 3 months after enrollment
Secondary outcomes (3)
Incidence of all-cause mortality
The data will be obtained at 3-month follow-up, according to medical records of all patients.
Measured: 3 months after enrollment
Incidence of myocardial infarction
The data will be obtained at 3-month follow-up, according to medical records of all patients.
Measured: 3 months after enrollment
Incidence of stroke
The data will be obtained at 3-month follow-up, according to medical records of all patients.
Measured: 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start15 Jan 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shaanxi Provincial People's Hospital, 521 Hospital of NORINCO Group, Xiangyang Central Hospital, Ankang Central Hospital, Baoji Central Hospital, Luoyang Central Hospital, Tianjin Medical University Second Hospital, Fu Wai Hospital, Beijing, China, Fuwai Yunnan Cardiovascular Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital
- Responsible party
- Sponsor
- Investigators
- Guoliang Li, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694273
- Sponsor's protocol ID
- XJTU1AF2023LSK-531
- Acronym
- CENTRAL
- Status last verified
- Mar 2024
- First submitted
- 10 Jan 2023
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Cerebrovascular Events in Patients Undergoing Catheter Ablation (CENTRAL): an Investigator-initiated, Multicenter Real-world Study
- ClinicalTrials.gov ID
- NCT05694273
- Acronym / sponsor ID
- CENTRAL / XJTU1AF2023LSK-531
- Conditions
- Arrhythmia, Acute Cerebrovascular Disease
- Keywords
- Catheter ablation, Arrhythmia, Major adverse cardiovascular and cerebrovascular events (MACCE)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Shaanxi Provincial People's Hospital, 521 Hospital of NORINCO Group, Xiangyang Central Hospital, Ankang Central Hospital, Baoji Central Hospital, Luoyang Central Hospital, Tianjin Medical University Second Hospital, Fu Wai Hospital, Beijing, China, Fuwai Yunnan Cardiovascular Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the incidence, clinical characteristics, and short-term prognosis of acute cerebrovascular events occurring in-hospital in patients with arrhythmias following catheter ablation. The goal is to provide evidence supporting the improvement of patient quality of life and reduction of in-hospital acute cerebrovascular complications in patients with post-ablation arrhythmias. This will also contribute to the evidence-based clinical management of such patients.
Detailed description
With the steady development of catheter ablation, it has gradually become the main treatment of various arrhythmias. Antithrombotic and anticoagulant therapy after catheter ablation determines the occurrence of perioperative bleeding and ischemic events. However, the incidence, characteristics and short-term prognosis of secondary acute cerebrovascular events in patients with arrhythmia after catheter ablation have not been studied. Methods: This study was intended to retrospectively collect and analyze the case data and auxiliary examination results of patients with arrhythmia who underwent catheter ablation. To evaluate the incidence, clinical features and short-term prognosis of secondary acute ischemic and hemorrhagic cerebrovascular events in patients with arrhythmia after catheter ablation. In order to improve the quality of life of patients, reduce the secondary acute cerebrovascular complications in the hospital in patients with arrhythmia after catheter ablation, to provide evidence for promoting the clinical management of such patients, and to provide help for the maximum degree of prevention and control risk.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ischemic stroke group | – | –1. Ischemic stroke secondary to patients receiving catheter ablation. 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 | – | –1. Transient ischemic attack secondary to patients receiving catheter ablation. 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 | – | –1. Cerebral hemorrhage secondary to patients receiving catheter ablation. 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. |
| Contral group | – | –Patients who did not experience acute cerebrovascular events in the hospital. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study plans to enroll patients with arrhythmias who undergo catheter ablation and meet the specified inclusion and exclusion criteria.
Key inclusion criteria (1 listed)
- 1.Patients who undergo catheter ablation for arrhythmias.
Key exclusion criteria (3 listed)
- 1. Patients were diagnosed of acute cerebrovascular disease prior to radiofrequency catheter ablation;
- 2. Patients < 18 years or > 80 years;
- 3. Patients with uncomplete clinical data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of MACCE
Time frame: 3 months after enrollment
Major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, myocardial infarction and stroke. The data will be obtained at 3-month follow-up, according to medical records of all patients.
3 secondary outcomes
Incidence of all-cause mortality
Time frame: 3 months after enrollment
Incidence of myocardial infarction
Time frame: 3 months after enrollment
Incidence of stroke
Time frame: 3 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guoliang Li principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmia and Acute Cerebrovascular Disease, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoliang li (+8613759982523, liguoliang_med@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of MACCE (time frame: 3 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.