NCT02251665

Brief 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, process for diagnosis and acute treatment, and long-term outcomes of stroke/TIA patients over the years.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,374

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Oct 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Oct 2016Mar 2028

First Submitted

Initial submission to the registry

September 23, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2014

Completed
2 years until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

10.4 years

First QC Date

September 23, 2014

Last Update Submit

November 7, 2023

Conditions

Stroke, Acute

Keywords

Acute ischemic strokeAcute intracerebral hemorrhageTransient ischemic attack

Outcome Measures

Primary Outcomes (1)

  • The modified Rankin Scale (mRS), a measure of disability

    mRS scores range from 0 (no symptoms at all) to 6 (death)

    3 monhts

Secondary Outcomes (8)

  • Number of participants

    at entry

  • National Institutes of Health Stroke Scale score

    at entry

  • Volume of culprit infarcts/hematoma

    at entry

  • The modified Rankin Scale (mRS), a measure of disability

    around 3 weeks

  • The modified Rankin Scale (mRS), a measure of disability

    1 year

  • +3 more secondary outcomes

Study Arms (1)

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

Other: No intervention

Interventions

No interventionOTHER

a single-center prospective observational study

Acute ischemic stroke, acute ICH, TIA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatients

You may qualify if:

  • 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

You may not qualify if:

  • \) Patients considered by the investigator to be unsuitable for participating in this registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cerebral and Cardiovascular Center

Suita, Osaka, 564-8565, Japan

Location

Related Publications (22)

  • 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.

    PMID: 25030514RESULT

  • Osaki 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.

    PMID: 24200315RESULT

  • Sakamoto 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.

    PMID: 24103668RESULT

  • Sato 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.

    PMID: 23859180RESULT

  • Kobayashi 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.

    PMID: 23652273RESULT

  • Tanaka 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.

    PMID: 24621380RESULT

  • Tomii 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.

    PMID: 21960578RESULT

  • Koga 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.

    PMID: 24135558RESULT

  • Inoue 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.

    PMID: 28361615RESULT

  • Koge 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.

    PMID: 41585290DERIVED

  • Yamaguchi 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.

    PMID: 41582976DERIVED

  • Inui 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.

    PMID: 38187149DERIVED

  • Yoshimoto 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.

    PMID: 37421278DERIVED

  • Okada T, Yoshimoto T, Wada S, Yoshimura S, Chiba T, Egashira S, Kimura S, Shiozawa M, Inoue M, Ihara M, Toyoda K, Takashima H, Koga M. Intravenous Thrombolysis With Alteplase at 0.6 mg/kg in Patients With Ischemic Stroke Taking Direct Oral Anticoagulants. J Am Heart Assoc. 2022 Oct 4;11(19):e025809. doi: 10.1161/JAHA.122.025809. Epub 2022 Sep 21.

    PMID: 36129032DERIVED

  • Koge J, Tanaka K, Yoshimoto T, Shiozawa M, Kushi Y, Ohta T, Satow T, Kataoka H, Ihara M, Koga M, Isobe N, Toyoda K. Internal Carotid Artery Tortuosity: Impact on Mechanical Thrombectomy. Stroke. 2022 Aug;53(8):2458-2467. doi: 10.1161/STROKEAHA.121.037904. Epub 2022 Apr 11.

    PMID: 35400203DERIVED

  • Inoue M, Yoshimoto T, Tanaka K, Koge J, Shiozawa M, Nishii T, Ohta Y, Fukuda T, Satow T, Kataoka H, Yamagami H, Ihara M, Koga M, Mlynash M, Albers GW, Toyoda K. Mechanical Thrombectomy Up to 24 Hours in Large Vessel Occlusions and Infarct Velocity Assessment. J Am Heart Assoc. 2021 Dec 21;10(24):e022880. doi: 10.1161/JAHA.121.022880. Epub 2021 Dec 10.

    PMID: 34889115DERIVED

  • Yoshimoto T, Shiozawa M, Koge J, Inoue M, Koga M, Ihara M, Toyoda K. Evaluation of Workflow Delays in Stroke Reperfusion Therapy: A Comparison between the Year-Long Pre-COVID-19 Period and the with-COVID-19 Period. J Atheroscler Thromb. 2022 Jul 1;29(7):1095-1107. doi: 10.5551/jat.63090. Epub 2021 Aug 13.

    PMID: 34393139DERIVED

  • Koge J, Tanaka K, Yoshimoto T, Shiozawa M, Yamagami H, Satow T, Takahashi JC, Ihara M, Koga M, Kira JI, Toyoda K. Early recurrent ischemic events after mechanical thrombectomy: effect of post-treatment intracranial hemorrhage. J Neurol. 2021 Aug;268(8):2810-2820. doi: 10.1007/s00415-021-10449-1. Epub 2021 Feb 16.

    PMID: 33594451DERIVED

  • Yoshimoto T, Inoue M, Yamagami H, Fujita K, Tanaka K, Ando D, Sonoda K, Kamogawa N, Koga M, Ihara M, Toyoda K. Use of Diffusion-Weighted Imaging-Alberta Stroke Program Early Computed Tomography Score (DWI-ASPECTS) and Ischemic Core Volume to Determine the Malignant Profile in Acute Stroke. J Am Heart Assoc. 2019 Nov 19;8(22):e012558. doi: 10.1161/JAHA.119.012558. Epub 2019 Nov 8.

    PMID: 31698986DERIVED

  • Fujita K, Tanaka K, Yamagami H, Ide T, Ishiyama H, Sonoda K, Satow T, Takahashi JC, Ihara M, Koga M, Yokota T, Toyoda K. Detrimental Effect of Chronic Hypertension on Leptomeningeal Collateral Flow in Acute Ischemic Stroke. Stroke. 2019 Jul;50(7):1751-1757. doi: 10.1161/STROKEAHA.119.025142. Epub 2019 May 16.

    PMID: 31233392DERIVED

  • Takasugi J, Yamagami H, Noguchi T, Morita Y, Tanaka T, Okuno Y, Yasuda S, Toyoda K, Gon Y, Todo K, Sakaguchi M, Nagatsuka K. Detection of Left Ventricular Thrombus by Cardiac Magnetic Resonance in Embolic Stroke of Undetermined Source. Stroke. 2017 Sep;48(9):2434-2440. doi: 10.1161/STROKEAHA.117.018263. Epub 2017 Aug 17.

    PMID: 28818863DERIVED

  • Hashimoto T, Hayakawa M, Funatsu N, Yamagami H, Satow T, Takahashi JC, Nagatsuka K, Ishibashi-Ueda H, Kira JI, Toyoda K. Histopathologic Analysis of Retrieved Thrombi Associated With Successful Reperfusion After Acute Stroke Thrombectomy. Stroke. 2016 Dec;47(12):3035-3037. doi: 10.1161/STROKEAHA.116.015228. Epub 2016 Oct 25.

    PMID: 27780903DERIVED

Related Links

MeSH Terms

Conditions

StrokeIschemic StrokeIschemic Attack, Transient

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Study Officials

  • Kazunori Toyoda, MD, PhD

    Vice Director of the Hospital, National Cerebral and Cardiovascular Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director and Chair, Dept. of Stroke and Cerebrovascular Diseases

Study Record Dates

First Submitted

September 23, 2014

First Posted

September 29, 2014

Study Start

October 1, 2016

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

November 9, 2023

Record last verified: 2023-11

Locations

JP(1)