Association of Apolipoprotein B-48 Level and Large arterY Atherosclerotic iSchemic Stroke(ABYSS)

• Conditions: Acute Ischemic Stroke

• Registration Number: NCT01233986
• Lead Sponsor: Hallym University Medical Center

Brief Summary

The purpose of this study is to evaluate whether the serum apoB48 level is associated with atherosclerotic ischemic stroke.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-10-21
• Status Verified: 2010-11
• Study First Submitted QC: 2010-11-02
• Study First Posted: 2010-11-04
• Primary Completion: 2011-03
• Study Completion: 2011-10
• Last Update Submitted: 2011-10-04
• Last Update Posted: 2011-10-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Large artery atherosclerotic ischemic stroke group(LAA group)

• Age over 20 years
• Patients with symptomatic stenosis in the eligible vessels(the middle cerebral artery, anterior cerebral artery, or internal carotid artery) as assessed by MRA or CTA corresponding to the acute ischemic stroke
• Patients without the occlusion of corresponding artery by MRA or CTA
• The fasting and postprandial serum Apo B-48 level can be assessed within 72 hours after the symptom onset of ischemic stroke

Small vessel occlusive ischemic stroke group (SVO group)

• Age over 20 years
• Patients with acute ischemic stroke of basal ganglia, internal capsule, or corona radiata
• Patients without both symptomatic and asymptomatic arterial occlusion or stenosis by MRA or CTA
• Patients without a history of systemic atherosclerosis(for example, acute myocardial infarction, angina, peripheral arterial disease, aortic aneurysm)
• The fasting and postprandial serum Apo B-48 level can be assessed within 72 hours after the symptom onset of ischemic stroke

Exclusion Criteria

both LAA group and SVO group

• Patients with cardioembolic ischemic stroke
• Patients treated with lipid lowering agents or steroid within the previous 30 dsys
• Patients with severe liver disease (AST >100 or ALT >100) at the time of randomization
• Patients with endocrine disease except diabetes mellitus at the time of randomization (for example, thyroid disease, adrenal disease)
• Patients with severe renal disease (serum creatinine >2.0mg/dl)at the time of randomization
• chronic alcoholics or drug user
• Patients with infection at the time of randomization
• Patients, in the opinion of the investigator, unlikely to comply with the clinical study or unsuitable for the any other disease or reason
• Informed consent has not been obtained

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The serum level of fasting apolipoprotein B-48	72 hours within stroke onset
The serum level of postprandial apolipoprotein B-48	within 72 hours after stroke onset

Secondary Outcome Measures

Name	Time	Method
The serum level of fasting total cholesterol	within 72 hours after stroke onset
The serum level of the postprandial triglyceride	72 hours within stroke onset
The serum level of fasting LDL cholesterol	within 72 hours after stroke onset
the level of fasting HDL cholesterol	within 72 hours after stroke onset
the level of fasting triglyceride	within 72 hours after stroke onset

Trial Locations

Locations (1)

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Korea, Republic of