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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
Sponsor:
Information provided by (Responsible Party):
Hallym University Medical Center

Study Description
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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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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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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

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


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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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