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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease
Acute Ischemic Stroke

Study Design

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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

Groups and Cohorts

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. The serum level of fasting apolipoprotein B-48 [ Time Frame: 72 hours within stroke onset ]
2. The serum level of postprandial apolipoprotein B-48 [ Time Frame: within 72 hours after stroke onset ]

Secondary Outcome Measures :

1. The serum level of the postprandial triglyceride [ Time Frame: 72 hours within stroke onset ]
2. The serum level of fasting total cholesterol [ Time Frame: within 72 hours after stroke onset ]
3. The serum level of fasting LDL cholesterol [ Time Frame: within 72 hours after stroke onset ]
4. the level of fasting HDL cholesterol [ Time Frame: within 72 hours after stroke onset ]
5. the level of fasting triglyceride [ Time Frame: within 72 hours after stroke onset ]

Biospecimen Retention:   Samples Without DNA

Serum level of apolipoprotein B-48

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Study Population

Tertiary Hospital

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

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

Locations

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

Sponsors and Collaborators

Hallym University Medical Center

Investigators

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

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Hallym University Medical Center
ClinicalTrials.gov Identifier:	NCT01233986 History of Changes
Other Study ID Numbers:	ABYSS
First Posted:	November 4, 2010
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