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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJinan Central Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial population

Adult patients who had acute ischemic stroke symptoms within 7 days and previously or during this hospitalization diagnosed with non-valvular atrial fibrillation.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Patients with acute ischemic stroke and atrial fibrillation1 intervention

Trial outcomes

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

Time frame
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

Time frame
3 years

Other outcomes

1

Ischemic stroke

Rapid onset of a new focal neurological deficit with clinical and imaging evidence of infarction and not attributable to a non-ischemic etiology.

Time frame
12, 36months
2

Hemorrhagic stroke

Hemorrhagic stroke is defined as an acute episode of focal or global cerebral or spinal dysfunction caused by a nontraumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage

Time frame
12, 36months
3

Systemic embolism

Systemic embolism was defined as an acute vascular occlusion of an extremity or organ confirmed by imaging or either surgery or autopsy.

Time frame
12, 36months
4

Myocardial infarction (MI)

Myocardial infarction will be assessed according to the third universal definition of myocardial infarction (Eur Heart J, 2012).

Time frame
12, 36months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.