Acute Ischemic StrokeNCT06548269
Multimodal Prognostic Assessment of Acute Ischemic Stroke Patients With Atrial Fibrillation: a Prospective, Multicenter, Observational Study (IAT-CLOSURE)
An observational study of Acute Ischemic Stroke and Atrial Fibrillation, run by Jinan Central Hospital at 1 site in China.
Trial summary
The main purpose of this study is to investigate the safety and outcomes of different treatment strategies, including best medical therapy (OAC [oral anticoagulation], antiplatelet [APT]) and left atrial appendage closure [LAAC] in acute ischemic stroke (AIS) patients with atrial fibrillation (AF) based on multimodal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Atrial Fibrillation
- What is being tested?
- Cardiologic work-up
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2024to 31 May 2029
- How long will I take part?
- 3 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who had acute ischemic stroke symptoms within 7 days and previously or during this hospitalization diagnosed with non-valvular atrial fibrillation.
Who may be able to join
- Age > 18 years old;
- Acute ischemic stroke with onset ≤ 14 days;
- Previously or during this hospitalization diagnosed with non-valvular atrial fibrillation;
- Informed consent obtained from the patient or his/her legal representative;
Who cannot join
- Pacemaker, implantable cardioverter defibrillator or implantable cardiac monitor;
- Left atrial appendage has been removed or post occlusion device implantation;
- Transient AF secondary to other reversible disorders;
- Life expectancy less than 1 year;
- Patients that cannot complete subsequent follow-up (e.g. no fixed residence, overseas patients, etc.);
- Females who are pregnant or in lactation;
- Participating in other clinical trials that could confound the evaluation of the study;
- Other circumstances that the investigator considers inappropriate for participation or may pose a significant risk to patients.
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, 1 recruiting
- Recruiting
Jinan Central Hospital
Jinan, Shandong, 250013
Yanxin Zhao, +86 13370582882, 13370582882@163.com
Wencheng Kong, +86 15614656050, kongwencheng@163.com
About this study
The main purpose of this study is to investigate the safety and outcomes of different treatment strategies, including best medical therapy (OAC [oral anticoagulation], antiplatelet [APT]) and left atrial appendage closure [LAAC] in acute ischemic stroke (AIS) patients with atrial fibrillation (AF) based on multimodal assessment from combined brain and cardiologic work-up, and to optimize secondary prevention.
Read the detailed description
Ischemic stroke is the leading cause of disability and mortality globally. Atrial fibrillation(AF) is a well-established risk factor for ischemic stroke and responsible for up to one-third of all strokes. AF-related ischemic strokes are more frequently fatal or disabling than non-AF strokes. The overall prevalence of known or newly diagnosed AF in stroke patients is approximately 39.0%. Detecting underlying AF remains important for secondary prevention of recurrent stroke, with a different strategy from atherosclerotic cause of stroke. The increasingly common use of prolonged cardiac monitoring (PCM) after ischemic stroke has greatly increased the detection rates of previously undiagnosed AF in ischemic strokes, which was demonstrated by a series of trials. Additionally, AF burden, defined as percentage of the time in AF during cardiac monitoring, has been regarded as an important prognostic risk factor for thromboembolism.
Currently, the CHA2DS2-VASc score is the most widely used scoring system for assessing ischemic stroke risk in patients with AF and basis for initiation of anticoagulation. Anticoagulation is currently recommended for male with CHA2DS2-VASc score≥2 or female with CHA2DS2-VASc score≥3. Direct oral anticoagulants (DOACs) have been increasingly used in the past decade due to their similar to superior efficacy to vitamin K antagonists (VKAs), but a lower intracerebral bleeding risk in non-valvular atrial fibrillation (NVAF), defined as AF in the absence of moderate to severe mitral stenosis or a mechanical heart valve. For patients with AF who cannot tolerate long-term OACs due to various relative or absolute contraindications, left atrial appendage closure (LAAC) offers an alternative treatment strategy for these patients. Moreover, as one-third of patients with ischemic stroke and AF may have concomitant large artery atherosclerosis or small vessel disease, it is still unclear whether these patients should be left untreated or treated with antiplatelet (APT), DOACs, or with LAAC.
Traditional clinical practice mainly focuses on the presence of AF but rarely incorporates AF burden into a risk stratification scoring system. To our knowledge, no studies to date have investigated recurrent stroke risk stratification in AIS patients with AF based on AF burden assessed by PCM, not to mention guidance of treatment strategy selection. Further, other multimodal assessments, such as cerebral CT/MRI (e.g. infarct size and location), serum biomarkers (e.g. BNP, troponin, D-dimer levels) and cardiac structural markers (e.g. LA volume or volume index, LAA morphologies) have been reported as promising prognostic factors of stroke severity and recurrence. A comprehensive evaluation system is still lacking. In this prospective and multicenter registry study, we determine to test the safety and effectiveness of best medical therapy (OAC, APT) and LAAC using multimodal assessment from combined brain and cardiologic work-up, with the aim to optimize secondary prevention in this patient population.
- Conditions
- Acute Ischemic Stroke, Atrial Fibrillation
- Being tested
- Cardiologic work-up
- Keywords
- Acute Ischemic Stroke, Atrial fibrillation, AF burden, Left atrial appendage closure
- Medical subject headings
- Ischemic Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiologic work-upDiagnostic test
Noninvasive prolonged ECG monitoring with a duration of 7 days measuring AF burden; Echocardiography measuring LA volume or volume index, LA diameter or diameter index; Cardiac CTA measuring LAA morphologies, cardiac thrombus.
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute ischemic stroke and atrial fibrillation | Adult patients with an acute ischemic stroke and atrial fibrillation will undergo a baseline work-up and cardiologic work-up. Baseline work-up includes admission 12-lead ECG,blood analysis, brain CT/MRI, brain CTA/MRA/vessel ultrasound. Cardiologic work-up includes prolonged ECG monitoring, echocardiography and cardiac CTA. Treatment will follow the current guidelines. Receives: Diagnostic Test: Cardiologic work-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoints of ischemic stroke, systemic embolism, myocardial infarction, major bleeding (BARC type 3-5) and all-cause mortality
Stroke only including ischemic stroke
Measured: 1 year
Secondary outcomes (1)
Composite endpoints of stroke, systemic embolism, myocardial infarction, major bleeding (BARC type 3-5) and all-cause mortality
Stroke including ischemic or hemorrhagic stroke
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start15 Nov 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Jinan Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548269
- Sponsor's protocol ID
- IAT-CLOSURE
- Status last verified
- Dec 2024
- First submitted
- 7 Aug 2024
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Prognostic Assessment of Acute Ischemic Stroke Patients With Atrial Fibrillation: a Prospective, Multicenter, Observational Study (IAT-CLOSURE)
- ClinicalTrials.gov ID
- NCT06548269
- Acronym / sponsor ID
- IAT-CLOSURE
- Conditions
- Acute Ischemic Stroke, Atrial Fibrillation
- Keywords
- Acute Ischemic Stroke, Atrial fibrillation, AF burden, Left atrial appendage closure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Jinan Central HospitalUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 12 Aug 2024 (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.
The main purpose of this study is to investigate the safety and outcomes of different treatment strategies, including best medical therapy (OAC [oral anticoagulation], antiplatelet [APT]) and left atrial appendage closure [LAAC] in acute ischemic stroke (AIS) patients with atrial fibrillation (AF) based on multimodal assessment from combined brain and cardiologic work-up, and to optimize secondary prevention.
Detailed description
Ischemic stroke is the leading cause of disability and mortality globally. Atrial fibrillation(AF) is a well-established risk factor for ischemic stroke and responsible for up to one-third of all strokes. AF-related ischemic strokes are more frequently fatal or disabling than non-AF strokes. The overall prevalence of known or newly diagnosed AF in stroke patients is approximately 39.0%. Detecting underlying AF remains important for secondary prevention of recurrent stroke, with a different strategy from atherosclerotic cause of stroke. The increasingly common use of prolonged cardiac monitoring (PCM) after ischemic stroke has greatly increased the detection rates of previously undiagnosed AF in ischemic strokes, which was demonstrated by a series of trials. Additionally, AF burden, defined as percentage of the time in AF during cardiac monitoring, has been regarded as an important prognostic risk factor for thromboembolism.
Currently, the CHA2DS2-VASc score is the most widely used scoring system for assessing ischemic stroke risk in patients with AF and basis for initiation of anticoagulation. Anticoagulation is currently recommended for male with CHA2DS2-VASc score≥2 or female with CHA2DS2-VASc score≥3. Direct oral anticoagulants (DOACs) have been increasingly used in the past decade due to their similar to superior efficacy to vitamin K antagonists (VKAs), but a lower intracerebral bleeding risk in non-valvular atrial fibrillation (NVAF), defined as AF in the absence of moderate to severe mitral stenosis or a mechanical heart valve. For patients with AF who cannot tolerate long-term OACs due to various relative or absolute contraindications, left atrial appendage closure (LAAC) offers an alternative treatment strategy for these patients. Moreover, as one-third of patients with ischemic stroke and AF may have concomitant large artery atherosclerosis or small vessel disease, it is still unclear whether these patients should be left untreated or treated with antiplatelet (APT), DOACs, or with LAAC.
Traditional clinical practice mainly focuses on the presence of AF but rarely incorporates AF burden into a risk stratification scoring system. To our knowledge, no studies to date have investigated recurrent stroke risk stratification in AIS patients with AF based on AF burden assessed by PCM, not to mention guidance of treatment strategy selection. Further, other multimodal assessments, such as cerebral CT/MRI (e.g. infarct size and location), serum biomarkers (e.g. BNP, troponin, D-dimer levels) and cardiac structural markers (e.g. LA volume or volume index, LAA morphologies) have been reported as promising prognostic factors of stroke severity and recurrence. A comprehensive evaluation system is still lacking. In this prospective and multicenter registry study, we determine to test the safety and effectiveness of best medical therapy (OAC, APT) and LAAC using multimodal assessment from combined brain and cardiologic work-up, with the aim to optimize secondary prevention in this patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute ischemic stroke and atrial fibrillation | – | Diagnostic Test: Cardiologic work-upAdult patients with an acute ischemic stroke and atrial fibrillation will undergo a baseline work-up and cardiologic work-up. Baseline work-up includes admission 12-lead ECG,blood analysis, brain CT/MRI, brain CTA/MRA/vessel ultrasound. Cardiologic work-up includes prolonged ECG monitoring, echocardiography and cardiac CTA. Treatment will follow the current guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who had acute ischemic stroke symptoms within 7 days and previously or during this hospitalization diagnosed with non-valvular atrial fibrillation.
Key inclusion criteria (4 listed)
- Age > 18 years old;
- Acute ischemic stroke with onset ≤ 14 days;
- Previously or during this hospitalization diagnosed with non-valvular atrial fibrillation;
- Informed consent obtained from the patient or his/her legal representative;
Key exclusion criteria (8 listed)
- Pacemaker, implantable cardioverter defibrillator or implantable cardiac monitor;
- Left atrial appendage has been removed or post occlusion device implantation;
- Transient AF secondary to other reversible disorders;
- Life expectancy less than 1 year;
- Patients that cannot complete subsequent follow-up (e.g. no fixed residence, overseas patients, etc.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiologic work-upNoninvasive prolonged ECG monitoring with a duration of 7 days measuring AF burden; Echocardiography measuring LA volume or volume index, LA diameter or diameter index; Cardiac CTA measuring LAA morphologies, cardiac thrombus. | Diagnostic test | Patients with acute ischemic stroke and atrial fibrillation |
Primary outcome
Composite endpoints of ischemic stroke, systemic embolism, myocardial infarction, major bleeding (BARC type 3-5) and all-cause mortality
Time frame: 1 year
Stroke only including ischemic stroke
1 secondary outcome
Composite endpoints of stroke, systemic embolism, myocardial infarction, major bleeding (BARC type 3-5) and all-cause mortality
Time frame: 3 years
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 22 May 2025.
- Individual participant dataSharing planned: No
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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.
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 Acute Ischemic Stroke and Atrial Fibrillation, run by Jinan Central Hospital 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 22 May 2025. 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 Liqun Jiao (13911224991, liqunjiao@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoints of ischemic stroke, systemic embolism, myocardial infarction, major bleeding (BARC type 3-5) and all-cause mortality (time frame: 1 year). 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 22 May 2025.