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

The recruitment status of this study is unknown because the information has not been verified recently.
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
  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)

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
  • The serum level of postprandial apolipoprotein B-48 [ Time Frame: within 72 hours after stroke onset ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The serum level of the postprandial triglyceride [ Time Frame: 72 hours within stroke onset ] [ Designated as safety issue: No ]
  • The serum level of fasting total cholesterol [ Time Frame: within 72 hours after stroke onset ] [ Designated as safety issue: No ]
  • The serum level of fasting LDL cholesterol [ Time Frame: within 72 hours after stroke onset ] [ Designated as safety issue: No ]
  • the level of fasting HDL cholesterol [ Time Frame: within 72 hours after stroke onset ] [ Designated as safety issue: No ]
  • the level of fasting triglyceride [ Time Frame: within 72 hours after stroke onset ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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

No publications provided

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
Health Authority: South Korea: Institutional Review Board

Keywords provided by Hallym University Medical Center:
Acute Ischemic Stroke
Atherosclerosis
Apolipoprotein B48

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 21, 2014