Clinical trial NCT01233986: Association of Apolipoprotein B-48 Level and Large arterY Atherosclerotic iSchemic Stroke(ABYSS)
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Ischemic Stroke
Keywords: Acute Ischemic Stroke
Atherosclerosis
Apolipoprotein B48
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2010-11-04
Enrollment: 112
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tertiary Hospital

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


Eligibility 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

Primary outcomes:
measure: The serum level of fasting apolipoprotein B-48
timeFrame: 72 hours within stroke onset
measure: The serum level of postprandial apolipoprotein B-48
timeFrame: within 72 hours after stroke onset
Secondary outcomes:
measure: The serum level of the postprandial triglyceride
timeFrame: 72 hours within stroke onset
measure: The serum level of fasting total cholesterol
timeFrame: within 72 hours after stroke onset
measure: The serum level of fasting LDL cholesterol
timeFrame: within 72 hours after stroke onset
measure: the level of fasting HDL cholesterol
timeFrame: within 72 hours after stroke onset
measure: the level of fasting triglyceride
timeFrame: within 72 hours after stroke onset
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
Study officials:
affiliation: Hallym University Medical Center
name: Byung-Chul Lee, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: