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

NCT ID: NCT01233986

Last Updated: 2011-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-10-31

Brief Summary

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

Detailed Description

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Conditions

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Acute Ischemic Stroke

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Case group - Large artery atherosclerosis

No interventions assigned to this group

Control group-Small vessel occlusion

No interventions assigned to this group

Eligibility Criteria

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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

* 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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hallym University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Byung-Chul Lee, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Hallym University Medical Center

Locations

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Hallym University Sacred Heart Hospital

Anyang, Anyang, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Byung-Chul Lee, MD, PhD

Role: CONTACT

+82-31-380-3741

Kyung-Ho Yu, MD, PhD

Role: CONTACT

+82-31-380-3743

Facility Contacts

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Byung-chul Lee, MD,PhD

Role: primary

+82-31-380-3741

Kyung-Ho Yu, MD, PhD

Role: backup

+82-31-380-3743

Other Identifiers

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ABYSS

Identifier Type: -

Identifier Source: org_study_id