Association of Apolipoprotein B-48 Level and Large arterY Atherosclerotic iSchemic Stroke(ABYSS)
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ClinicalTrials.gov Identifier: NCT01233986 |
Recruitment Status
: Unknown
Verified November 2010 by Hallym University Medical Center.
Recruitment status was: Recruiting
First Posted
: November 4, 2010
Last Update Posted
: October 5, 2011
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Condition or disease |
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Acute Ischemic Stroke |
Study Type : | Observational |
Estimated Enrollment : | 112 participants |
Observational Model: | Case Control |
Time Perspective: | Prospective |
Official Title: | Prospective, Matched Case Control, Multicenter, Observational Study for the Association of Serum Apolipoprotein B-48 Level and Large arterY Atherosclerotic iSchemic Stroke(ABYSS) |
Study Start Date : | May 2010 |
Actual Primary Completion Date : | March 2011 |
Estimated Study Completion Date : | October 2011 |
Group/Cohort |
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Case group - Large artery atherosclerosis |
Control group-Small vessel occlusion |
- The serum level of fasting apolipoprotein B-48 [ Time Frame: 72 hours within stroke onset ]
- The serum level of postprandial apolipoprotein B-48 [ Time Frame: within 72 hours after stroke onset ]
- The serum level of the postprandial triglyceride [ Time Frame: 72 hours within stroke onset ]
- The serum level of fasting total cholesterol [ Time Frame: within 72 hours after stroke onset ]
- The serum level of fasting LDL cholesterol [ Time Frame: within 72 hours after stroke onset ]
- the level of fasting HDL cholesterol [ Time Frame: within 72 hours after stroke onset ]
- the level of fasting triglyceride [ Time Frame: within 72 hours after stroke onset ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01233986
Contact: Byung-Chul Lee, MD, PhD | +82-31-380-3741 | ssbrain@hallym.ac.kr | |
Contact: Kyung-Ho Yu, MD, PhD | +82-31-380-3743 | ykh1030@hallym.ac.kr |
Korea, Republic of | |
Hallym University Sacred Heart Hospital | Recruiting |
Anyang, Korea, Republic of | |
Contact: Byung-chul Lee, MD,PhD +82-31-380-3741 ssbrain@hallym.ac.kr | |
Contact: Kyung-Ho Yu, MD, PhD +82-31-380-3743 ykh1030@hallym.ac.kr | |
Sub-Investigator: Mi Sun Oh, MD |
Principal Investigator: | Byung-Chul Lee, MD,PhD | Hallym University Medical Center |
Responsible Party: | Hallym University Medical Center |
ClinicalTrials.gov Identifier: | NCT01233986 History of Changes |
Other Study ID Numbers: |
ABYSS |
First Posted: | November 4, 2010 Key Record Dates |
Last Update Posted: | October 5, 2011 |
Last Verified: | November 2010 |
Keywords provided by Hallym University Medical Center:
Acute Ischemic Stroke Atherosclerosis Apolipoprotein B48 |
Additional relevant MeSH terms:
Stroke Ischemia Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia |