Clinical trial NCT02251665: National Cerebral and Cardiovascular Center (NCVC) Stroke Registry
Official title: National Cerebral and Cardiovascular Center (NCVC) Stroke Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stroke, Acute
Keywords: Acute ischemic stroke
Acute intracerebral hemorrhage
Transient ischemic attack
Lead sponsor: National Cerebral and Cardiovascular Center, Japan
Sponsor class: OTHER
First posted: 2014-09-29
Enrollment: 5374
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients

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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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)
2. 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

Exclusion Criteria:

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

Primary outcomes:
measure: The modified Rankin Scale (mRS), a measure of disability
timeFrame: 3 monhts
Secondary outcomes:
measure: Number of participants
timeFrame: at entry
measure: National Institutes of Health Stroke Scale score
timeFrame: at entry
measure: Volume of culprit infarcts/hematoma
timeFrame: at entry
measure: The modified Rankin Scale (mRS), a measure of disability
timeFrame: around 3 weeks
measure: The modified Rankin Scale (mRS), a measure of disability
timeFrame: 1 year
measure: Events of cardiovascular diseases including stroke/TIA
timeFrame: around 3 weeks
measure: Events of cardiovascular diseases including stroke/TIA
timeFrame: 3 months
measure: Events of cardiovascular diseases including stroke/TIA
timeFrame: 1 year
Other outcomes:
Locations:
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center
state: Osaka
Study officials:
affiliation: Vice Director of the Hospital, National Cerebral and Cardiovascular Center
name: Kazunori Toyoda, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.