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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified November 2010 by Hallym University Medical Center.
Recruitment status was: Recruiting

Sponsor:

Information provided by (Responsible Party):

Hallym University Medical Center

ClinicalTrials.gov Identifier:

NCT01233986

First received: October 21, 2010

Last updated: October 4, 2011

Last verified: November 2010

History of Changes

Purpose

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

Condition
Acute Ischemic Stroke


Study Type:	Observational
Study Design:	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)

Further study details as provided by Hallym University Medical Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Serum level of apolipoprotein B-48


Estimated Enrollment:	112
Study Start Date:	May 2010
Estimated Study Completion Date:	October 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
Case group - Large artery atherosclerosis
Control group-Small vessel occlusion

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233986

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


Responsible Party:	Hallym University Medical Center
ClinicalTrials.gov Identifier:	NCT01233986 History of Changes
Other Study ID Numbers:	ABYSS
Study First Received:	October 21, 2010
Last Updated:	October 4, 2011

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

ClinicalTrials.gov processed this record on June 23, 2017

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