Atrial FibrillationNCT05598632
Risk Factors for Stroke or Systemic Embolism in Chinese Patients with Non-Valvular Atrial Fibrillation Registry
An observational study of Atrial Fibrillation and Stroke, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This study is aimed to validate the existing stroke risk stratification model for patients with atrial fibrillation (AF) (CHA2DS2-VASc Score, CHADS2 Score, ATRIA score, ABC score, etc.) and establish a new stroke risk assessment model using a nationwide AF -specific registry in China. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Atrial Fibrillation, Stroke
- How many people
- 22,000 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Atrial fibrillation patients without valvular heart disease, prevous/planned ablation or left atrial appendage closure.
Who may be able to join
- 18 years of age or older; male or female.
- History of documented atrial fibrillation.
- Able to provide written informed consent.
Who cannot join
- Subjects with moderate or severe mitral stenosis or a mechanical heart valve
- Subjects with previous or planned AF ablation.
- Subjects with previous or planned left atrial appendage closure.
- Subjects unable to cooperate with follow-up after assessment.
Trial locations and contacts
1 site in 1 country.
Shuo Yuan, MD contact
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, CAMS & PUMC
Beijing, Beijing Municipality, 100027
Yan Yao, MD, PhD, +86 187 0101 3797, ianyao@263.net
About this study
This study is aimed to validate the existing stroke risk stratification model for patients with atrial fibrillation (AF) (CHA2DS2-VASc Score, CHADS2 Score, ATRIA score, ABC score, etc.) and establish a new stroke risk assessment model using a nationwide AF -specific registry in China.
Read the detailed description
This study is a multicenter prospective disease-specific registry of patients with atrial fibrillation (AF) that will analyze factors that are associated with stroke or systemic embolic events in patients with AF in China. Approximately 5,000 prospective cohort of patients and 22,000 retrospective cohort of patients will be enrolled. Consecutive patients who meet the eligibility criteria and provide informed consent. Patients enrolled in the registry will be followed for approximately 3 years. Patient follow-up by National Center for Cardiovascular Diseases will continue as scheduled. Atrial Fibrillation Data capture will include demographics, cardiovascular risk factors, diagnosis, type of AF (paroxysmal, persistent, permanent AF), treatment strategy (rate vs. rhythm), antithrombotic therapy, concomitant medications and doses, laboratory tests, echo and computed tomography results, blood sample, insurance and provider information, comorbidities, and outcomes. The primary outcome will be stroke or non-CNS embolism. Other pre-defined outcomes of interest will include major adverse cardiac events, all-cause mortality, cause-specific death (sudden, non-sudden, heart failure-related), major bleeding, and hospitalization for heart failure.
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- Stroke, Atrial fibrillation, Risk factors, Registry
- Medical subject headings
- Atrial Fibrillation, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Stroke and Systemic Embolic Events (SEE)
The composite of stroke and Systemic Embolic Events (SEE) during follow-up. A stroke is defined as an abrupt onset, over minutes to hours, of a focal neurologic deficit that is generally in the distribution of a single brain artery (including the retinal artery) and that is not due to an identifiable nonvascular cause (ie, brain tumor or trauma).
A systemic embolic event is defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis, instrumentation). Arterial embolic events involving the central nervous system (including the eye), coronary, and pulmonary arterial circulation are not considered SEEs,. Diagnosis of embolism to the lower extremities requires arteriographic demonstration of abrupt arterial occlusion.
Measured: At 12-month after recruiting
Secondary outcomes (4)
Major Bleeding Events
A major bleeding event is defined as clinically overt bleeding event (ie, bleeding that is visualized by examination or radiologic imaging) that meets ≥1 of the following:
- Fatal bleeding
- Symptomatic bleeding in a critical area or organ such as:
- Retroperitoneal
- Intracranial
- Intraocular
- Intraspinal
- Intraarticular
- Pericardial
- Intramuscular with compartment syndrome
Measured: At 12-month after recruiting
All-Cause Mortality
All-Cause Mortality during follow-up
Measured: At 12-month after recruiting
Cardiac Death
Cardiac Death during follow-up
Measured: At 12-month after recruiting
Hospitalization for heart failure
Hospitalization for heart failure during follow-up
Measured: At 12-month after recruiting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start18 Apr 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Prospective
- Enrolment
- 22,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Zhe Zheng, MD, PhD, Study chair, Fuwai Hospital, Chinese Academy of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598632
- Sponsor's protocol ID
- 2021-CXGC09-1
- Status last verified
- Oct 2024
- First submitted
- 26 Oct 2022
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Qi W, Yuan S, Liu H, Xu M, Yang Y, Peng X, Hu Z, Zhang Y, Zhao Y, Zheng L, Yao Y, Zheng Z; Investigators the REFINE Registry; investors. Rationale, design and protocol for risk factors for stroke in patients with non-valvular atrial fibrillation in China: a nationwide registry (REFINE registry). BMJ Open. 2025 Nov 4;15(11):e104806. doi: 10.1136/bmjopen-2025-104806.
PubMed 41193204
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Stroke or Systemic Embolism in Chinese Patients with Non-Valvular Atrial Fibrillation Registry
- ClinicalTrials.gov ID
- NCT05598632
- Acronym / sponsor ID
- 2021-CXGC09-1
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- Stroke, Atrial fibrillation, Risk factors, Registry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22,000 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Oct 2022 (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 is aimed to validate the existing stroke risk stratification model for patients with atrial fibrillation (AF) (CHA2DS2-VASc Score, CHADS2 Score, ATRIA score, ABC score, etc.) and establish a new stroke risk assessment model using a nationwide AF -specific registry in China.
Detailed description
This study is a multicenter prospective disease-specific registry of patients with atrial fibrillation (AF) that will analyze factors that are associated with stroke or systemic embolic events in patients with AF in China. Approximately 5,000 prospective cohort of patients and 22,000 retrospective cohort of patients will be enrolled. Consecutive patients who meet the eligibility criteria and provide informed consent. Patients enrolled in the registry will be followed for approximately 3 years. Patient follow-up by National Center for Cardiovascular Diseases will continue as scheduled. Atrial Fibrillation Data capture will include demographics, cardiovascular risk factors, diagnosis, type of AF (paroxysmal, persistent, permanent AF), treatment strategy (rate vs. rhythm), antithrombotic therapy, concomitant medications and doses, laboratory tests, echo and computed tomography results, blood sample, insurance and provider information, comorbidities, and outcomes. The primary outcome will be stroke or non-CNS embolism. Other pre-defined outcomes of interest will include major adverse cardiac events, all-cause mortality, cause-specific death (sudden, non-sudden, heart failure-related), major bleeding, and hospitalization for heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Atrial fibrillation patients without valvular heart disease, prevous/planned ablation or left atrial appendage closure.
Key inclusion criteria (3 listed)
- 18 years of age or older; male or female.
- History of documented atrial fibrillation.
- Able to provide written informed consent.
Key exclusion criteria (4 listed)
- Subjects with moderate or severe mitral stenosis or a mechanical heart valve
- Subjects with previous or planned AF ablation.
- Subjects with previous or planned left atrial appendage closure.
- Subjects unable to cooperate with follow-up after assessment.
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
Composite of Stroke and Systemic Embolic Events (SEE)
Time frame: At 12-month after recruiting
The composite of stroke and Systemic Embolic Events (SEE) during follow-up. A stroke is defined as an abrupt onset, over minutes to hours, of a focal neurologic deficit that is generally in the distribution of a single brain artery (including the retinal artery) and that is not due to an identifiable nonvascular cause (ie, brain tumor or trauma). A systemic embolic event is defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis, instrumentation). Arterial embolic events involving the central nervous system (including the eye), coronary, and pulmonary arterial circulation are not considered SEEs,. Diagnosis of embolism to the lower extremities requires arteriographic demonstration of abrupt arterial occlusion.
4 secondary outcomes
Major Bleeding Events
Time frame: At 12-month after recruiting
All-Cause Mortality
Time frame: At 12-month after recruiting
Cardiac Death
Time frame: At 12-month after recruiting
Hospitalization for heart failure
Time frame: At 12-month after recruiting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Derived from this study: PubMed 41193204Qi W, Yuan S, Liu H, Xu M, Yang Y, Peng X, Hu Z, Zhang Y, Zhao Y, Zheng L, Yao Y, Zheng Z; Investigators the REFINE Registry; investors. Rationale, design and protocol for risk factors for stroke in patients with non-valvular atrial fibrillation in China: a nationwide registry (REFINE registry). BMJ Open. 2025 Nov 4;15(11):e104806. doi: 10.1136/bmjopen-2025-104806.
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Atrial Fibrillation (AF)
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. This study is not recruiting at the moment.
Shuo Yuan, MD contact
Zhe Zheng, MD, PhD study chair
Fuwai Hospital, Chinese Academy of Medical Science
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 Atrial Fibrillation and Stroke, run by China National Center for Cardiovascular Diseases 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhe Zheng, MD, PhD (+86-010-88396051, zhengzhe@fuwai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Stroke and Systemic Embolic Events (SEE) (time frame: At 12-month after recruiting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05598632, which also lists 1 linked publication.
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 6 Nov 2024.