Last updated: April 4, 2023
Sponsor: Asan Medical Center
Overall Status: Active - Recruiting
Phase
N/A
Condition
Dysrhythmia
Cerebral Ischemia
Chest Pain
Treatment
N/AClinical Study ID
NCT05431972
SOLO-ESUS
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Inclusion NO. 3 or 4 must be satisfied, and No. 2, 5 and 6 must be satisfied. 2. On the Screening date, Stroke onset date is not over 60 days. 3. ESUS Diagnosis : all of a~e must be satisfied.
- a. Ischemic stroke detected by CT or MRI that is not lacunar
- b. A person without arteriosclerosis which causes at least 50% stenosis of theintracranial/external arteries supplied to the ischemic site
- c. During continuous monitoring or halter monitoring In the stroke intensive careunit, Person without atrial fibrillation and persistent atrial fibrillation
- d. When checked the Transthoracic echocardiography, No major risk cardioembolic sourceof embolism. (ex. Myocardial infarction within 4 weeks, mitral stenosis, artificialheart valve and so on)
- e. NO other specific cause of stroke identified(et, arteritis, dissection and drugabuse)
- cardioembolism is classified by TOAST classification.
- Left ventricle Enlargement(male >40mm, female >38mm, LAVI >35ml/m2
- Voluntarily sign the consent form
Exclusion
Exclusion Criteria:
- Transient cerebral ischemic attack
- Active cancer
- Heart embolism, stroke of major heart embolism, stroke high-risk disease
- Left atrial thrombus
- Left ventricular thrombus
- Sick sinus syndrome
- Myocardiac infarction in 1 month
- Rheumatic left atrioventricular valve or aortic valve disease
- Artificial heart valve
- Myocardiac infarction (EF<28%)
- Congestive heart failure (EF<30%)
- Dilated cardiomyopathy
- Nonbacterial thrombotic endocarditis
- Endocarditis
- Intracardiac mass
- Atrial fibrillation
- Restriction for echocardiography (obesity, lung disease etc)
- High risk PFO
- Patch apply difficulty(skin allergy, ulticaria, atopic dermatitis, hyperhidrosis)
- Implant cardiac pacemaker
- Life-threatening arrhythmia
- Radiation therapy or MRI scan
- Restriction for Cardia SOLO attachment
- The person who investigator judged unsuitable for the trial
Study Design
Total Participants: 370
Study Start date:
November 01, 2022
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
BumJoon Kim
Seoul,
Korea, Republic ofActive - Recruiting
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