Acute Ischemic StrokeNCT01233986
Association of Apolipoprotein B-48 Level and Large arterY Atherosclerotic iSchemic Stroke(ABYSS)
An observational study of Acute Ischemic Stroke, run by Hallym University Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate whether the serum apoB48 level is associated with atherosclerotic ischemic stroke. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- How many people
- 112 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tertiary Hospital
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hallym University Sacred Heart Hospital
Anyang, Anyang
Byung-chul Lee, MD,PhD, +82-31-380-3741, ssbrain@hallym.ac.kr
Kyung-Ho Yu, MD, PhD, +82-31-380-3743, ykh1030@hallym.ac.kr
About this study
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)
The purpose of this study is to evaluate whether the serum apoB48 level is associated with atherosclerotic ischemic stroke.
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Atherosclerosis, Apolipoprotein B48
- Medical subject headings
- Ischemic Stroke, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case group - Large artery atherosclerosis | Not described | |
| Control group-Small vessel occlusion | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The serum level of fasting apolipoprotein B-48
Measured: 72 hours within stroke onset
The serum level of postprandial apolipoprotein B-48
Measured: within 72 hours after stroke onset
Secondary outcomes (5)
The serum level of the postprandial triglyceride
Measured: 72 hours within stroke onset
The serum level of fasting total cholesterol
Measured: within 72 hours after stroke onset
The serum level of fasting LDL cholesterol
Measured: within 72 hours after stroke onset
the level of fasting HDL cholesterol
Measured: within 72 hours after stroke onset
the level of fasting triglyceride
Measured: within 72 hours after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startMay 2010
- Primary completionMar 2011
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Byung-Chul Lee, MD,PhD, Principal investigator, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233986
- Sponsor's protocol ID
- ABYSS
- Status last verified
- Nov 2010
- First submitted
- 21 Oct 2010
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01233986
- Acronym / sponsor ID
- ABYSS
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Atherosclerosis, Apolipoprotein B48
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Oct 2011 (estimated)
- First posted
- 4 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether the serum apoB48 level is associated with atherosclerotic ischemic stroke.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group - Large artery atherosclerosis | – | – |
| Control group-Small vessel occlusion | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary Hospital
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byung-Chul Lee, MD,PhD principal investigator
Hallym University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Hallym University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Byung-Chul Lee, MD, PhD (+82-31-380-3741, ssbrain@hallym.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The serum level of fasting apolipoprotein B-48 (time frame: 72 hours within stroke onset). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2011.