Ischemic Attack, TransientNCT00553241
Short-Term Prognosis Evaluation of Transient Ischemic Attack Patients Using ABCD2 Score
An observational study of Ischemic Attack, Transient, run by Capital Medical University at 1 site in China.
Trial summary
The purpose of this study is to determine whether the ABCD2 score can be used in patients with transient ischemic attack, admitted to Beijing anzhen hospital, to evaluate the prognosis, risk factor of those patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Attack, Transient
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- Jun 2007to Jan 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients diagnosed with transient will be enrolled in this study
Who may be able to join
- Every patient admitted to Beijing anzhen hospital with transient ischemic attack will be enrolled in this study, from 06/2007 to 12/2008. duration of the symptom not larger than 1 hour.
- Magnetic resonance imaging negative on DWI(no fresh infarction).
- Old infarction or not the criminal infarction.
Who cannot join
- Patients with hemorrhage stroke were excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dept. of Neurology, Beijing Anzhen Hospital, Capital Medical University
Beijing, 100029
li F Wang, wlfsjnk@163.com
Bi Qi
About this study
Official title: Phase 1 of Clinical Trial of Risk Factor, Prognosis, Imaging and Standard Management of Transient Ischemic Attack.
The purpose of this study is to determine whether the ABCD2 score can be used in patients with transient ischemic attack, admitted to Beijing anzhen hospital, to evaluate the prognosis, risk factor of those patients.
Read the detailed description
The feasibility of risk stratification of patients with acute transient ischemic attack admitted to Beijing anzhen hospital by the ABCD2 score system is yet to be determined. The aim of this paper was to evaluate and validate the short-term prognosis of TIA patients in Peking area using this new score system.
- Conditions
- Ischemic Attack, Transient
- Keywords
- TIA, prognosis, evaluation, management
- Medical subject headings
- Ischemic Attack, Transient
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 |
|---|---|---|
| 1 | Dept. of Neurology, Beijing Anzhen Hospital, Capital Medical University Beijing 100029, P.R.China Every patient admitted to Beijing anzhen hospital with transient ischemic attack will be enrolled in this study, from 06/2007 to 12/2008. duration of the symptom not larger than 1 hour. |
What is being measured
The primary outcome is the main question the study is designed to answer.
end points are defined as follow: transient ischemic attack, stroke, angina, myocardial infraction, peripheral vascular disease, intracerebral hemorrhage and other vascular death.
Measured: two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2007 (estimated)
- Study startJun 2007
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Ischemic Attack, TransientStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Anzhen Hospital
- Investigators
- Qi Bi, Study chair, Dept. of Neurology, Beijing Anzhen Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553241
- Sponsor's protocol ID
- 2007020
- Status last verified
- Jan 2009
- First submitted
- 2 Nov 2007
- Last updated
- 30 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Prabhakaran S, Chong JY, Sacco RL. Impact of abnormal diffusion-weighted imaging results on short-term outcome following transient ischemic attack. Arch Neurol. 2007 Aug;64(8):1105-9. doi: 10.1001/archneur.64.8.1105.
PubMed 17698700Johnston SC, Gress DR, Browner WS, Sidney S. Short-term prognosis after emergency department diagnosis of TIA. JAMA. 2000 Dec 13;284(22):2901-6. doi: 10.1001/jama.284.22.2901.
PubMed 11147987Weisberg LA. Clinical characteristics of transient ischemic attacks in black patients. Neurology. 1991 Sep;41(9):1410-4. doi: 10.1212/wnl.41.9.1410.
PubMed 1891090Albers GW, Caplan LR, Easton JD, Fayad PB, Mohr JP, Saver JL, Sherman DG; TIA Working Group. Transient ischemic attack--proposal for a new definition. N Engl J Med. 2002 Nov 21;347(21):1713-6. doi: 10.1056/NEJMsb020987. No abstract available.
PubMed 12444191Coull AJ, Lovett JK, Rothwell PM; Oxford Vascular Study. Population based study of early risk of stroke after transient ischaemic attack or minor stroke: implications for public education and organisation of services. BMJ. 2004 Feb 7;328(7435):326. doi: 10.1136/bmj.37991.635266.44. Epub 2004 Jan 26.
PubMed 14744823Correia M, Silva MR, Magalhaes R, Guimaraes L, Silva MC. Transient ischemic attacks in rural and urban northern Portugal: incidence and short-term prognosis. Stroke. 2006 Jan;37(1):50-5. doi: 10.1161/01.STR.0000195209.26543.8f. Epub 2005 Dec 1.
PubMed 16322498Clark TG, Murphy MF, Rothwell PM. Long term risks of stroke, myocardial infarction, and vascular death in "low risk" patients with a non-recent transient ischaemic attack. J Neurol Neurosurg Psychiatry. 2003 May;74(5):577-80. doi: 10.1136/jnnp.74.5.577.
PubMed 12700296Giles MF, Flossman E, Rothwell PM. Patient behavior immediately after transient ischemic attack according to clinical characteristics, perception of the event, and predicted risk of stroke. Stroke. 2006 May;37(5):1254-60. doi: 10.1161/01.STR.0000217388.57851.62. Epub 2006 Mar 30.
PubMed 16574923Sylaja PN, Coutts SB, Subramaniam S, Hill MD, Eliasziw M, Demchuk AM; VISION Study Group. Acute ischemic lesions of varying ages predict risk of ischemic events in stroke/TIA patients. Neurology. 2007 Feb 6;68(6):415-9. doi: 10.1212/01.wnl.0000252938.76188.52.
PubMed 17283315Johnston SC, Rothwell PM, Nguyen-Huynh MN, Giles MF, Elkins JS, Bernstein AL, Sidney S. Validation and refinement of scores to predict very early stroke risk after transient ischaemic attack. Lancet. 2007 Jan 27;369(9558):283-92. doi: 10.1016/S0140-6736(07)60150-0.
PubMed 17258668Tsivgoulis G, Spengos K, Manta P, Karandreas N, Zambelis T, Zakopoulos N, Vassilopoulos D. Validation of the ABCD score in identifying individuals at high early risk of stroke after a transient ischemic attack: a hospital-based case series study. Stroke. 2006 Dec;37(12):2892-7. doi: 10.1161/01.STR.0000249007.12256.4a. Epub 2006 Oct 19.
PubMed 17053179Rothwell PM, Giles MF, Flossmann E, Lovelock CE, Redgrave JN, Warlow CP, Mehta Z. A simple score (ABCD) to identify individuals at high early risk of stroke after transient ischaemic attack. Lancet. 2005 Jul 2-8;366(9479):29-36. doi: 10.1016/S0140-6736(05)66702-5.
PubMed 15993230Bray JE, Coughlan K, Bladin C. Can the ABCD Score be dichotomised to identify high-risk patients with transient ischaemic attack in the emergency department? Emerg Med J. 2007 Feb;24(2):92-5. doi: 10.1136/emj.2006.041624.
PubMed 17251611
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 of Clinical Trial of Risk Factor, Prognosis, Imaging and Standard Management of Transient Ischemic Attack.
- ClinicalTrials.gov ID
- NCT00553241
- Acronym / sponsor ID
- 2007020
- Conditions
- Ischemic Attack, Transient
- Keywords
- TIA, prognosis, evaluation, management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Anzhen Hospital
- Study start
- Jun 2007
- Study completion
- Jan 2009 (estimated)
- First posted
- 5 Nov 2007 (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 determine whether the ABCD2 score can be used in patients with transient ischemic attack, admitted to Beijing anzhen hospital, to evaluate the prognosis, risk factor of those patients.
Detailed description
The feasibility of risk stratification of patients with acute transient ischemic attack admitted to Beijing anzhen hospital by the ABCD2 score system is yet to be determined. The aim of this paper was to evaluate and validate the short-term prognosis of TIA patients in Peking area using this new score system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Dept. of Neurology, Beijing Anzhen Hospital, Capital Medical University Beijing 100029, P.R.China Every patient admitted to Beijing anzhen hospital with transient ischemic attack will be enrolled in this study, from 06/2007 to 12/2008. duration of the symptom not larger than 1 hour. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients diagnosed with transient will be enrolled in this study
Key inclusion criteria (3 listed)
- Every patient admitted to Beijing anzhen hospital with transient ischemic attack will be enrolled in this study, from 06/2007 to 12/2008. duration of the symptom not larger than 1 hour.
- Magnetic resonance imaging negative on DWI(no fresh infarction).
- Old infarction or not the criminal infarction.
Key exclusion criteria (1 listed)
- Patients with hemorrhage stroke were excluded.
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
end points are defined as follow: transient ischemic attack, stroke, angina, myocardial infraction, peripheral vascular disease, intracerebral hemorrhage and other vascular death.
Time frame: two year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2009.
- Background: PubMed 17698700Prabhakaran S, Chong JY, Sacco RL. Impact of abnormal diffusion-weighted imaging results on short-term outcome following transient ischemic attack. Arch Neurol. 2007 Aug;64(8):1105-9. doi: 10.1001/archneur.64.8.1105.
- Background: PubMed 11147987Johnston SC, Gress DR, Browner WS, Sidney S. Short-term prognosis after emergency department diagnosis of TIA. JAMA. 2000 Dec 13;284(22):2901-6. doi: 10.1001/jama.284.22.2901.
- Background: PubMed 1891090Weisberg LA. Clinical characteristics of transient ischemic attacks in black patients. Neurology. 1991 Sep;41(9):1410-4. doi: 10.1212/wnl.41.9.1410.
- Background: PubMed 12444191Albers GW, Caplan LR, Easton JD, Fayad PB, Mohr JP, Saver JL, Sherman DG; TIA Working Group. Transient ischemic attack--proposal for a new definition. N Engl J Med. 2002 Nov 21;347(21):1713-6. doi: 10.1056/NEJMsb020987. No abstract available.
- Background: PubMed 14744823Coull AJ, Lovett JK, Rothwell PM; Oxford Vascular Study. Population based study of early risk of stroke after transient ischaemic attack or minor stroke: implications for public education and organisation of services. BMJ. 2004 Feb 7;328(7435):326. doi: 10.1136/bmj.37991.635266.44. Epub 2004 Jan 26.
- Background: PubMed 16322498Correia M, Silva MR, Magalhaes R, Guimaraes L, Silva MC. Transient ischemic attacks in rural and urban northern Portugal: incidence and short-term prognosis. Stroke. 2006 Jan;37(1):50-5. doi: 10.1161/01.STR.0000195209.26543.8f. Epub 2005 Dec 1.
- Background: PubMed 12700296Clark TG, Murphy MF, Rothwell PM. Long term risks of stroke, myocardial infarction, and vascular death in "low risk" patients with a non-recent transient ischaemic attack. J Neurol Neurosurg Psychiatry. 2003 May;74(5):577-80. doi: 10.1136/jnnp.74.5.577.
- Background: PubMed 16574923Giles MF, Flossman E, Rothwell PM. Patient behavior immediately after transient ischemic attack according to clinical characteristics, perception of the event, and predicted risk of stroke. Stroke. 2006 May;37(5):1254-60. doi: 10.1161/01.STR.0000217388.57851.62. Epub 2006 Mar 30.
- Background: PubMed 17283315Sylaja PN, Coutts SB, Subramaniam S, Hill MD, Eliasziw M, Demchuk AM; VISION Study Group. Acute ischemic lesions of varying ages predict risk of ischemic events in stroke/TIA patients. Neurology. 2007 Feb 6;68(6):415-9. doi: 10.1212/01.wnl.0000252938.76188.52.
- Results publication: PubMed 17258668Johnston SC, Rothwell PM, Nguyen-Huynh MN, Giles MF, Elkins JS, Bernstein AL, Sidney S. Validation and refinement of scores to predict very early stroke risk after transient ischaemic attack. Lancet. 2007 Jan 27;369(9558):283-92. doi: 10.1016/S0140-6736(07)60150-0.
- Results publication: PubMed 17053179Tsivgoulis G, Spengos K, Manta P, Karandreas N, Zambelis T, Zakopoulos N, Vassilopoulos D. Validation of the ABCD score in identifying individuals at high early risk of stroke after a transient ischemic attack: a hospital-based case series study. Stroke. 2006 Dec;37(12):2892-7. doi: 10.1161/01.STR.0000249007.12256.4a. Epub 2006 Oct 19.
- Results publication: PubMed 15993230Rothwell PM, Giles MF, Flossmann E, Lovelock CE, Redgrave JN, Warlow CP, Mehta Z. A simple score (ABCD) to identify individuals at high early risk of stroke after transient ischaemic attack. Lancet. 2005 Jul 2-8;366(9479):29-36. doi: 10.1016/S0140-6736(05)66702-5.
- Related InfoLink provided by the sponsor.
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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.
Dept. of Neurology, Beijing Anzhen Hospital, Capital Medical University
Beijing, China
Qi Bi study chair
Dept. of Neurology, Beijing Anzhen Hospital, Capital Medical University
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 Ischemic Attack, Transient, run by Capital Medical University at 1 site in China.
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 3 inclusion and 1 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 30 Jan 2009. 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
end points are defined as follow: transient ischemic attack, stroke, angina, myocardial infraction, peripheral vascular disease, intracerebral hemorrhage and other vascular death. (time frame: two year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00553241, which also lists 13 linked publications.
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 30 Jan 2009.