Stroke, AcuteNCT02251665
National Cerebral and Cardiovascular Center (NCVC) Stroke Registry
An observational study of Stroke, Acute, run by National Cerebral and Cardiovascular Center, Japan at 1 site in Japan.
Trial summary
A single-center registry of patients with acute ischemic stroke, intracerebral hemorrhage, and transient ischemic attack (TIA) who are emergently managed in the stroke care unit in the National Cerebral and Cardiovascular Center (NCVC) to determine change in underlying characteristics, stroke features and severity… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Acute
- How many people
- 5,374 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2016to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Inpatients
Who may be able to join
- A patient with acute ischemic stroke, intracerebral hemorrhage, and transient ischemic attack who are emergently managed in the stroke care unit or stroke units in the National Cerebral and Cardiovascular Center (NCVC)
- Consent to participate in the registration by a patient or relatives obtained using an opt-out approach by the demonstrating contents of the registration on the hospital bulletin board
Who cannot join
- 1) Patients considered by the investigator to be unsuitable for participating in this registry
Trial locations and contacts
1 site in 1 country.
About this study
A single-center registry of patients with acute ischemic stroke, intracerebral hemorrhage, and transient ischemic attack (TIA) who are emergently managed in the stroke care unit in the National Cerebral and Cardiovascular Center (NCVC) to determine change in underlying characteristics, stroke features and severity, process for diagnosis and acute treatment, and long-term outcomes of stroke/TIA patients over the years.
Read the detailed description
This is a single-center registry of consecutive patients with acute ischemic stroke, intracerebral hemorrhage, and transient ischemic attack (TIA) who are emergently managed in the stroke care unit in the National Cerebral and Cardiovascular Center, a flagship stroke center in Japan.
Neurological emergencies other than stroke/TIA and subclinical cerebrobvascular inpatients are also enrolled.
Data are collected and analyzed to determine change in underlying characteristics, stroke features and severity, process for diagnosis and acute treatment, and long-term outcomes of stroke/TIA patients over the years.
The National Cerebral and Cardiovascular Center was founded in 1977 in Suita, Osaka, in order to provide the public with the most advanced treatment for cardiovascular and cerebrovascular diseases and to conduct the highest level of basic as well as applied research on the cardiovascular and cerebrovascular systems.
- Conditions
- Stroke, Acute
- Being tested
- No intervention
- Keywords
- Acute ischemic stroke, Acute intracerebral hemorrhage, Transient ischemic attack
- Medical subject headings
- Stroke, Ischemic Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
a single-center prospective observational study
| Study group | Role | What they receive |
|---|---|---|
| Acute ischemic stroke, acute ICH, TIA | Consecutive patients with acute ischemic stroke, intracerebral hemorrhage, and transient ischemic attack who are emergently managed in the stroke care unit or stroke units in the National Cerebral and Cardiovascular Center Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The modified Rankin Scale (mRS), a measure of disability
mRS scores range from 0 (no symptoms at all) to 6 (death)
Measured: 3 monhts
Secondary outcomes (8)
Number of participants
Also assessing underlying patients' characteristics prior to index stroke/TIA
Measured: at entry
National Institutes of Health Stroke Scale score
Also assessing neurological and cognitive states
Measured: at entry
Volume of culprit infarcts/hematoma
ASPECTS on DWI for ischemia or hematoma volume using the ABC/2 method
Measured: at entry
The modified Rankin Scale (mRS), a measure of disability
mRS scores range from 0 (no symptoms at all) to 6 (death). Participants will be followed at hospital discharge, an expected average of 3 weeks.
Measured: around 3 weeks
The modified Rankin Scale (mRS), a measure of disability
mRS scores range from 0 (no symptoms at all) to 6 (death)
Measured: 1 year
Events of cardiovascular diseases including stroke/TIA
Participants will be followed at hospital discharge, an expected average of 3 weeks.
Measured: around 3 weeks
Events of cardiovascular diseases including stroke/TIA
Measured: 3 months
Events of cardiovascular diseases including stroke/TIA
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startOct 2016
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 5,374 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cerebral and Cardiovascular Center, Japan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazunori Toyoda, National Cerebral and Cardiovascular Center, Japan
- Investigators
- Kazunori Toyoda, MD, PhD, Principal investigator, Vice Director of the Hospital, National Cerebral and Cardiovascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251665
- Sponsor's protocol ID
- NationalCardioCenter
- Status last verified
- Nov 2023
- First submitted
- 23 Sep 2014
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Toyoda K, Ninomiya T. Stroke and cerebrovascular diseases in patients with chronic kidney disease. Lancet Neurol. 2014 Aug;13(8):823-33. doi: 10.1016/S1474-4422(14)70026-2.
PubMed 25030514Osaki M, Miyashita F, Koga M, Fukuda M, Shigehatake Y, Nagatsuka K, Minematsu K, Toyoda K. Simple clinical predictors of stroke outcome based on National Institutes of Health Stroke scale score during 1-h recombinant tissue-type plasminogen activator infusion. Eur J Neurol. 2014 Mar;21(3):411-8. doi: 10.1111/ene.12294. Epub 2013 Nov 7.
PubMed 24200315Sakamoto Y, Sato S, Kuronuma Y, Nagatsuka K, Minematsu K, Toyoda K. Factors associated with proximal carotid axis occlusion in patients with acute stroke and atrial fibrillation. J Stroke Cerebrovasc Dis. 2014 May-Jun;23(5):799-804. doi: 10.1016/j.jstrokecerebrovasdis.2013.07.002. Epub 2013 Oct 6.
PubMed 24103668Sato S, Uehara T, Hayakawa M, Nagatsuka K, Minematsu K, Toyoda K. Intra- and extracranial atherosclerotic disease in acute spontaneous intracerebral hemorrhage. J Neurol Sci. 2013 Sep 15;332(1-2):116-20. doi: 10.1016/j.jns.2013.06.031. Epub 2013 Jul 13.
PubMed 23859180Kobayashi J, Uehara T, Toyoda K, Endo K, Ohara T, Fujinami J, Nagatsuka K, Minematsu K. Clinical significance of fluid-attenuated inversion recovery vascular hyperintensities in transient ischemic attack. Stroke. 2013 Jun;44(6):1635-40. doi: 10.1161/STROKEAHA.111.000787. Epub 2013 May 7.
PubMed 23652273Tanaka K, Koga M, Sato K, Suzuki R, Minematsu K, Toyoda K. Three-dimensional analysis of the left atrial appendage for detecting paroxysmal atrial fibrillation in acute ischemic stroke. Int J Stroke. 2014 Dec;9(8):1045-51. doi: 10.1111/ijs.12268. Epub 2014 Mar 13.
PubMed 24621380Tomii Y, Toyoda K, Suzuki R, Naganuma M, Fujinami J, Yokota C, Minematsu K. Effects of 24-hour blood pressure and heart rate recorded with ambulatory blood pressure monitoring on recovery from acute ischemic stroke. Stroke. 2011 Dec;42(12):3511-7. doi: 10.1161/STROKEAHA.111.628586. Epub 2011 Sep 29.
PubMed 21960578Koga M, Arihiro S, Miyashita F, Yamamoto H, Yamada N, Nagatsuka K, Minematsu K, Toyoda K. Factors associated with early recanalization failure following intravenous rt-PA therapy for ischemic stroke. Cerebrovasc Dis. 2013;36(4):299-305. doi: 10.1159/000355054. Epub 2013 Oct 16.
PubMed 24135558Inoue Y, Miyashita F, Koga M, Minematsu K, Toyoda K. Unclear-onset intracerebral hemorrhage: Clinical characteristics, hematoma features, and outcomes. Int J Stroke. 2017 Dec;12(9):961-968. doi: 10.1177/1747493017702664. Epub 2017 Mar 31.
PubMed 28361615Miwa K, Toyoda K, Arakaki Y, Ogawa A, Inutsuka R, Iwamoto S, Shiozawa M, Ihara M, Koga M. Covert cerebral small vessel disease and outcomes after spontaneous intracerebral hemorrhage. J Cereb Blood Flow Metab. 2026 Sep 10:271678X261490344. doi: 10.1177/0271678X261490344. Online ahead of print.
PubMed 42723274Kuroda T, Tanaka T, Saito S, Bhaskar S, Ishiyama H, Inui R, Shiomi Y, Nakaoku Y, Ogata S, Morita Y, Ozaki E, Kuriyama N, Nishimura K, Koga M, Nakahara J, Toyoda K, Ihara M. Differential impact of smoking on intracerebral haemorrhage based on cerebral microbleed status: a case-control study. BMJ Open. 2026 Jun 30;16(6):e116158. doi: 10.1136/bmjopen-2025-116158.
PubMed 42379713Koge J, Tanaka K, Yoshimoto T, Shiozawa M, Ohta T, Satow T, Kataoka H, Ihara M, Koga M, Toyoda K. Mechanical Thrombectomy Beyond 2b Reperfusion: Should We Pursue a Higher Reperfusion Grade after Achievement of 2b? Stroke Vasc Interv Neurol. 2022 Jan 12;2(1):e000196. doi: 10.1161/SVIN.121.000196. eCollection 2022 Jan.
PubMed 41585290Yamaguchi E, Yoshimoto T, Ogura S, Saito K, Saito S, Hattori Y, Wasida K, Nishimura K, Toyoda K, Koga M, Ihara M. Association of the RNF213 p.R4810K Variant With the Outer Diameter of Cervical Arteries in Patients With Ischemic Stroke. Stroke Vasc Interv Neurol. 2022 Mar 24;2(6):e000298. doi: 10.1161/SVIN.121.000298. eCollection 2022 Nov.
PubMed 41582976Inui R, Koge J, Tanaka K, Yoshimoto T, Shiozawa M, Abe S, Ishiyama H, Imamura H, Nakahara J, Kataoka H, Ihara M, Toyoda K, Koga M. Detrimental effect of anemia after mechanical thrombectomy on functional outcome in patients with ischemic stroke. Front Neurol. 2023 Dec 19;14:1299891. doi: 10.3389/fneur.2023.1299891. eCollection 2023.
PubMed 38187149Yoshimoto T, Inoue M, Tanaka K, Koge J, Shiozawa M, Kamogawa N, Ishiyama H, Abe S, Imamura H, Kataoka H, Koga M, Ihara M, Toyoda K. Tmax Mismatch Ratio to Identify Intracranial Atherosclerotic Stenosis-Related Large-Vessel Occlusion Before Endovascular Therapy. J Am Heart Assoc. 2023 Jul 18;12(14):e029899. doi: 10.1161/JAHA.123.029899. Epub 2023 Jul 8.
PubMed 37421278
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Cerebral and Cardiovascular Center (NCVC) Stroke Registry
- ClinicalTrials.gov ID
- NCT02251665
- Acronym / sponsor ID
- NationalCardioCenter
- Conditions
- Stroke, Acute
- Keywords
- Acute ischemic stroke, Acute intracerebral hemorrhage, Transient ischemic attack
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,374 participants (actual)
- Lead sponsor
- National Cerebral and Cardiovascular Center, JapanUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 29 Sep 2014 (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.
A single-center registry of patients with acute ischemic stroke, intracerebral hemorrhage, and transient ischemic attack (TIA) who are emergently managed in the stroke care unit in the National Cerebral and Cardiovascular Center (NCVC) to determine change in underlying characteristics, stroke features and severity, process for diagnosis and acute treatment, and long-term outcomes of stroke/TIA patients over the years.
Detailed description
This is a single-center registry of consecutive patients with acute ischemic stroke, intracerebral hemorrhage, and transient ischemic attack (TIA) who are emergently managed in the stroke care unit in the National Cerebral and Cardiovascular Center, a flagship stroke center in Japan.
Neurological emergencies other than stroke/TIA and subclinical cerebrobvascular inpatients are also enrolled.
Data are collected and analyzed to determine change in underlying characteristics, stroke features and severity, process for diagnosis and acute treatment, and long-term outcomes of stroke/TIA patients over the years.
The National Cerebral and Cardiovascular Center was founded in 1977 in Suita, Osaka, in order to provide the public with the most advanced treatment for cardiovascular and cerebrovascular diseases and to conduct the highest level of basic as well as applied research on the cardiovascular and cerebrovascular systems.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute ischemic stroke, acute ICH, TIA | – | Other: No interventionConsecutive patients with acute ischemic stroke, intracerebral hemorrhage, and transient ischemic attack who are emergently managed in the stroke care unit or stroke units in the National Cerebral and Cardiovascular Center |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inpatients
Key inclusion criteria (2 listed)
- A patient with acute ischemic stroke, intracerebral hemorrhage, and transient ischemic attack who are emergently managed in the stroke care unit or stroke units in the National Cerebral and Cardiovascular Center (NCVC)
- Consent to participate in the registration by a patient or relatives obtained using an opt-out approach by the demonstrating contents of the registration on the hospital bulletin board
Key exclusion criteria (1 listed)
- 1) Patients considered by the investigator to be unsuitable for participating in this registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventiona single-center prospective observational study | Other | Acute ischemic stroke, acute ICH, TIA |
Primary outcome
The modified Rankin Scale (mRS), a measure of disability
Time frame: 3 monhts
mRS scores range from 0 (no symptoms at all) to 6 (death)
8 secondary outcomes
Number of participants
Time frame: at entry
National Institutes of Health Stroke Scale score
Time frame: at entry
Volume of culprit infarcts/hematoma
Time frame: at entry
The modified Rankin Scale (mRS), a measure of disability
Time frame: around 3 weeks
The modified Rankin Scale (mRS), a measure of disability
Time frame: 1 year
Events of cardiovascular diseases including stroke/TIA
Time frame: around 3 weeks
Events of cardiovascular diseases including stroke/TIA
Time frame: 3 months
Events of cardiovascular diseases including stroke/TIA
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Results publication: PubMed 25030514Toyoda K, Ninomiya T. Stroke and cerebrovascular diseases in patients with chronic kidney disease. Lancet Neurol. 2014 Aug;13(8):823-33. doi: 10.1016/S1474-4422(14)70026-2.
- Results publication: PubMed 24200315Osaki M, Miyashita F, Koga M, Fukuda M, Shigehatake Y, Nagatsuka K, Minematsu K, Toyoda K. Simple clinical predictors of stroke outcome based on National Institutes of Health Stroke scale score during 1-h recombinant tissue-type plasminogen activator infusion. Eur J Neurol. 2014 Mar;21(3):411-8. doi: 10.1111/ene.12294. Epub 2013 Nov 7.
- Results publication: PubMed 24103668Sakamoto Y, Sato S, Kuronuma Y, Nagatsuka K, Minematsu K, Toyoda K. Factors associated with proximal carotid axis occlusion in patients with acute stroke and atrial fibrillation. J Stroke Cerebrovasc Dis. 2014 May-Jun;23(5):799-804. doi: 10.1016/j.jstrokecerebrovasdis.2013.07.002. Epub 2013 Oct 6.
- Results publication: PubMed 23859180Sato S, Uehara T, Hayakawa M, Nagatsuka K, Minematsu K, Toyoda K. Intra- and extracranial atherosclerotic disease in acute spontaneous intracerebral hemorrhage. J Neurol Sci. 2013 Sep 15;332(1-2):116-20. doi: 10.1016/j.jns.2013.06.031. Epub 2013 Jul 13.
- Results publication: PubMed 23652273Kobayashi J, Uehara T, Toyoda K, Endo K, Ohara T, Fujinami J, Nagatsuka K, Minematsu K. Clinical significance of fluid-attenuated inversion recovery vascular hyperintensities in transient ischemic attack. Stroke. 2013 Jun;44(6):1635-40. doi: 10.1161/STROKEAHA.111.000787. Epub 2013 May 7.
- Results publication: PubMed 24621380Tanaka K, Koga M, Sato K, Suzuki R, Minematsu K, Toyoda K. Three-dimensional analysis of the left atrial appendage for detecting paroxysmal atrial fibrillation in acute ischemic stroke. Int J Stroke. 2014 Dec;9(8):1045-51. doi: 10.1111/ijs.12268. Epub 2014 Mar 13.
- Results publication: PubMed 21960578Tomii Y, Toyoda K, Suzuki R, Naganuma M, Fujinami J, Yokota C, Minematsu K. Effects of 24-hour blood pressure and heart rate recorded with ambulatory blood pressure monitoring on recovery from acute ischemic stroke. Stroke. 2011 Dec;42(12):3511-7. doi: 10.1161/STROKEAHA.111.628586. Epub 2011 Sep 29.
- Results publication: PubMed 24135558Koga M, Arihiro S, Miyashita F, Yamamoto H, Yamada N, Nagatsuka K, Minematsu K, Toyoda K. Factors associated with early recanalization failure following intravenous rt-PA therapy for ischemic stroke. Cerebrovasc Dis. 2013;36(4):299-305. doi: 10.1159/000355054. Epub 2013 Oct 16.
- Results publication: PubMed 28361615Inoue Y, Miyashita F, Koga M, Minematsu K, Toyoda K. Unclear-onset intracerebral hemorrhage: Clinical characteristics, hematoma features, and outcomes. Int J Stroke. 2017 Dec;12(9):961-968. doi: 10.1177/1747493017702664. Epub 2017 Mar 31.
- Derived from this study: PubMed 42723274Miwa K, Toyoda K, Arakaki Y, Ogawa A, Inutsuka R, Iwamoto S, Shiozawa M, Ihara M, Koga M. Covert cerebral small vessel disease and outcomes after spontaneous intracerebral hemorrhage. J Cereb Blood Flow Metab. 2026 Sep 10:271678X261490344. doi: 10.1177/0271678X261490344. Online ahead of print.
- Derived from this study: PubMed 42379713Kuroda T, Tanaka T, Saito S, Bhaskar S, Ishiyama H, Inui R, Shiomi Y, Nakaoku Y, Ogata S, Morita Y, Ozaki E, Kuriyama N, Nishimura K, Koga M, Nakahara J, Toyoda K, Ihara M. Differential impact of smoking on intracerebral haemorrhage based on cerebral microbleed status: a case-control study. BMJ Open. 2026 Jun 30;16(6):e116158. doi: 10.1136/bmjopen-2025-116158.
- Derived from this study: PubMed 41585290Koge J, Tanaka K, Yoshimoto T, Shiozawa M, Ohta T, Satow T, Kataoka H, Ihara M, Koga M, Toyoda K. Mechanical Thrombectomy Beyond 2b Reperfusion: Should We Pursue a Higher Reperfusion Grade after Achievement of 2b? Stroke Vasc Interv Neurol. 2022 Jan 12;2(1):e000196. doi: 10.1161/SVIN.121.000196. eCollection 2022 Jan.
- Official home page of the National Cerebral and Cardiovascular CenterLink 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.
Kazunori Toyoda, MD, PhD principal investigator
Vice Director of the Hospital, National Cerebral and Cardiovascular 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 Stroke, Acute, run by National Cerebral and Cardiovascular Center, Japan at 1 site in Japan.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 9 Nov 2023. 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 Japan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The modified Rankin Scale (mRS), a measure of disability (time frame: 3 monhts). 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 NCT02251665, which also lists 25 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 9 Nov 2023.