National Cerebral and Cardiovascular Center (NCVC) Stroke Registry

Stroke, Acute Clinical Trial

Official title:

National Cerebral and Cardiovascular Center (NCVC) Stroke Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02251665
• Other study ID #: NationalCardioCenter
• Status: Active, not recruiting
• Start date: October 2016
• Est. completion date: March 2028

Study information

• Verified date: November 2023
• Source: National Cerebral and Cardiovascular Center, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5374
• Est. completion date: March 2028
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Other:
• No intervention
a single-center prospective observational study

Locations

Country	Name	City	State
Japan	National Cerebral and Cardiovascular Center	Suita	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
National Cerebral and Cardiovascular Center, Japan

Country where clinical trial is conducted

Japan, 

References & Publications (9)

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. — View 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/STROK — View 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: 10.1159/00035 — View 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 infu — View 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.jstroke — View 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. — View 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 201 — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The modified Rankin Scale (mRS), a measure of disability	mRS scores range from 0 (no symptoms at all) to 6 (death)	3 monhts
Secondary	Number of participants	Also assessing underlying patients' characteristics prior to index stroke/TIA	at entry
Secondary	National Institutes of Health Stroke Scale score	Also assessing neurological and cognitive states	at entry
Secondary	Volume of culprit infarcts/hematoma	ASPECTS on DWI for ischemia or hematoma volume using the ABC/2 method	at entry
Secondary	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.	around 3 weeks
Secondary	The modified Rankin Scale (mRS), a measure of disability	mRS scores range from 0 (no symptoms at all) to 6 (death)	1 year
Secondary	Events of cardiovascular diseases including stroke/TIA	Participants will be followed at hospital discharge, an expected average of 3 weeks.	around 3 weeks
Secondary	Events of cardiovascular diseases including stroke/TIA		3 months
Secondary	Events of cardiovascular diseases including stroke/TIA		1 year

External Links

•   Official home page of the National Cerebral and Cardiovascular Center