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

Prospective, Matched Case Control, Multicenter, Observational Study for the Association of Serum Apolipoprotein B-48 Level and Large arterY Atherosclerotic iSchemic Stroke(ABYSS)

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

Study Overview

• Status: Unknown
• Conditions: Acute Ischemic Stroke

• Study Type: Observational
• Enrollment (Anticipated): 112

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Recruiting
    • Hallym University Sacred Heart Hospital
    • Contact: Kyung-Ho Yu, MD, PhD; Phone Number: +82-31-380-3743; Email: ykh1030@hallym.ac.kr
    • Contact: Byung-chul Lee, MD,PhD; Phone Number: +82-31-380-3741; Email: ssbrain@hallym.ac.kr
    • Sub-Investigator: Mi Sun Oh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Tertiary Hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Case group - Large artery atherosclerosis
Control group-Small vessel occlusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
The serum level of the postprandial triglyceride	72 hours within stroke onset
The serum level of fasting total cholesterol	within 72 hours after 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

Collaborators and Investigators

• Sponsor: Hallym University Medical Center
• Investigators: Principal Investigator: Byung-Chul Lee, MD,PhD, Hallym University Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ANTICIPATED): October 1, 2011

Study Registration Dates

• First Submitted: October 21, 2010
• First Submitted That Met QC Criteria: November 2, 2010
• First Posted (ESTIMATE): November 4, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 5, 2011
• Last Update Submitted That Met QC Criteria: October 4, 2011
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Atherosclerosis; Acute Ischemic Stroke; Apolipoprotein B48
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: ABYSS