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

Acute Ischemic Stroke Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01233986
• Other study ID #: ABYSS
• Status: Recruiting
• Phase: N/A
• First received: October 21, 2010
• Last updated: October 4, 2011
• Start date: May 2010
• Est. completion date: October 2011

Study information

• Verified date: November 2010
• Source: Hallym University Medical Center
• Contact: Byung-Chul Lee, MD, PhD
• Phone: +82-31-380-3741
• Email: ssbrain[@]hallym.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: October 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Stroke

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The serum level of fasting apolipoprotein B-48		72 hours within stroke onset	No
Primary	The serum level of postprandial apolipoprotein B-48		within 72 hours after stroke onset	No
Secondary	The serum level of the postprandial triglyceride		72 hours within stroke onset	No
Secondary	The serum level of fasting total cholesterol		within 72 hours after stroke onset	No
Secondary	The serum level of fasting LDL cholesterol		within 72 hours after stroke onset	No
Secondary	the level of fasting HDL cholesterol		within 72 hours after stroke onset	No
Secondary	the level of fasting triglyceride		within 72 hours after stroke onset	No