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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000014147 |
Receipt No. | R000016474 |
Scientific Title | Comparison of arteriosclerotic indicators in patients with ischemic stroke |
Date of disclosure of the study information | 2014/06/04 |
Last modified on | 2015/03/18 |
Basic information | ||
Public title | Comparison of arteriosclerotic indicators in patients with ischemic stroke | |
Acronym | Comparison of arteriosclerotic indicators in patients with ischemic stroke (cross-sectional study) | |
Scientific Title | Comparison of arteriosclerotic indicators in patients with ischemic stroke | |
Scientific Title:Acronym | Comparison of arteriosclerotic indicators in patients with ischemic stroke (cross-sectional study) | |
Region |
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Condition | |||||
Condition | Cerebrovascular diseases | ||||
Classification by specialty |
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Classification by malignancy | Others | ||||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To compare the arteriosclerotic indicators in patients with ischemic stroke: ankle-brachial index, brachial-ankle pulse wave velocity, and cardio-ankle vascular index |
Basic objectives2 | Others |
Basic objectives -Others | Ankle-brachial index (ABI), brachial-ankle pulse wave velocity (baPWV), and cardio-ankle vascular index (CAVI) are surrogate markers of arteriosclerosis. However, analyses of these indicators in patients with ischemic stroke still remain unclear. |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | The aim of the present study was to compare ABI, baPWV, and CAVI in patients with ischemic stroke and those without a history of stroke. |
Key secondary outcomes |
Base | |
Study type | Observational |
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Gender | Male and Female | |||
Key inclusion criteria | October 2003 and September 2011, we consecutively enrolled patients with first-ever ischemic stroke admitted to the Hyogo Brain and Heart Center at Himeji within 48 hours after stroke onset. | |||
Key exclusion criteria | Patients were excluded if following were present: (1) recurrent stroke, (2) stroke of cardioembolism with either high or medium risk potential cardiac sources of embolism based on the Trial of Org 10172 in Acute Stroke Treatment (TOAST) classification, (3) stroke of other determined etiology based on the TOAST classification, (4) ABI <0.9. | |||
Target sample size | 800 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hyogo Brain and Heart Center at Himeji (Kawasaki Medical School) | ||||||
Division name | Department of Neurology (Department of Stroke Medicine) | ||||||
Zip code | |||||||
Address | 520 Saisho-ko, Himeji, Hyogo 670-0981, Japan (577 Matsushima, Kurashiki, Okayama 701-0192, Japan) | ||||||
TEL | 079-293-3131 | ||||||
sajink@nifty.com |
Public contact | |||||||
Name of contact person |
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Organization | Kawasaki Medical School | ||||||
Division name | Department of Stroke Medicine | ||||||
Zip code | |||||||
Address | 577 Matsushima, Kurashiki, Okayama 701-0192, Japan | ||||||
TEL | 086-462-1111 | ||||||
Homepage URL | |||||||
sajink@nifty.com |
Sponsor | |
Institute | Department of Neurology, Hyogo Brain and Heart Center at Himeji (Department of Stroke Medicine, Kawasaki Medical School) |
Institute | |
Department |
Funding Source | |
Organization | The KAWASAKI Foundation for Medical Science & Medical Welfare. |
Organization | |
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Category of Funding Organization | Self funding |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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Study ID_2 | |
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IND to MHLW |
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Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | http://www.nature.com/hr/journal/vaop/ncurrent/full/hr20158a.html |
Number of participants that the trial has enrolled | |
Results | Between October 2003 and September 2011, we consecutively enrolled patients with stroke presenting with large infarcts (diameter more than 1.5cm) attribute to large artery atherosclerosis (LAA) or lacunar infarcts (diameter less than 1.5cm) attribute to small artery disease (SAD). Outpatients without a history stroke were recruited as a control group (CTL). We divided the study period into two terms and assessed recruited patients using two oscillometric devises respectively in each term. Concretely, ABI and baPWV were measured using Form PWV/ABI during the former term. ABI and CAVI were measured using VaSera VS-1500 during the latter term.
A total of 1380 patients with acute ischemic stroke admitted to the Hyogo Brain and Heart Center at Himeji within 48 hours after stroke onset during the study period. Among them, we excluded 488 patients with cardioembolism and 384 patients with other determined etiology. Of 508 remaining patients, we excluded 126 patients; 69 recurrent stroke, 39 lack of data, and 18 having ABI <0.9. Hence, 382 patients with first-ever ischemic stroke consisting of 280 as SAD and 102 as LAA were enrolled. As a control group (CTL), 460 outpatients consisting of 240 recruited in the first period and 220 recruited in the second period were also enrolled in this study. Finally, we analyzed 842 patients. |
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Recruitment status | Completed | ||||||
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Other | |
Other related information | For further details, please see the article. |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016474 |
Research Plan | |
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Research case data | |
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