Multimodal Prognostic Assessment of Acute Ischemic Stroke Patients With Atrial Fibrillation: a Prospective, Multicenter, Observational Study (IAT-CLOSURE)

NCT06548269 | Recruiting DMC

• 1 other identifier: IAT-CLOSURE
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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 assessment from combined brain and cardiologic work-up, and to optimize secondary prevention.

Conditions

Acute Ischemic Stroke; Atrial Fibrillation

Keywords

Acute Ischemic Stroke; Atrial fibrillation; AF burden; Left atrial appendage closure

Outcome Measures

Primary Outcomes (1)

• Composite endpoints of ischemic stroke, systemic embolism, myocardial infarction, major bleeding (BARC type 3-5) and all-cause mortality

  Stroke only including ischemic stroke

  1 year

Secondary Outcomes (1)

• Composite endpoints of stroke, systemic embolism, myocardial infarction, major bleeding (BARC type 3-5) and all-cause mortality

  3 years

Other Outcomes (10)

• Ischemic stroke

  12, 36months

• Hemorrhagic stroke

  12, 36months

• Systemic embolism

  12, 36months

Study Arms (1)

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.

Diagnostic Test: Cardiologic work-up

Interventions

Cardiologic work-up DIAGNOSTIC_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.

Patients with acute ischemic stroke and atrial fibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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；

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinan Central Hospital: lead

Study Sites (1)

Jinan Central Hospital

Jinan, Shandong, 250013, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Liqun Jiao

CONTACT

13911224991; liqunjiao@sina.cn

Guohai Su

CONTACT

19953193319; suguohai1@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 12, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2029
• Last Updated: May 22, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)