UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040555 |
|---|---|
| Receipt number | R000046289 |
| Scientific Title | Hyperdense artery sign at non-contrast computed tomography reconstructed images for selecting patients for endovascular therapy |
| Date of disclosure of the study information | 2020/05/31 |
| Last modified on | 2022/12/04 21:01:27 |
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Basic information
Public title
Hyperdense artery sign at non-contrast computed tomography reconstructed images for selecting patients for endovascular therapy
Acronym
HASTE study
Scientific Title
Hyperdense artery sign at non-contrast computed tomography reconstructed images for selecting patients for endovascular therapy
Scientific Title:Acronym
HASTE study
Region
| Japan |
Condition
Condition
Acute ischemic stroke
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To address the usefulness of hyperdense artery sign at non-conrast computed tomography reconstructed images for selecting acute stroke patients for endovascular therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Door-to-puncture time
Key secondary outcomes
Concordance rate between the site of hyperdense artery sign and occlusion site in digital subtraction angiography
modified Rankin Scale at 90 days
Ischemic stroke recurrence, symptomatic intracranial hemorrhage and death withn 90 days
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
When there is a hyperdense artery sign at non-contrast computed tomography reconstructed images, digital subtraction angiography is immediately performed before acute endovascular therapy. If there is no hyperdense artery sign, additional vascular imaging including carotid duplex ultrasound, MR angiography or CT angiography is considered.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Endovascular treatment can be initiated within 6 hours of symptom onset
NIHSS score of >=6
ASPECTS of >=6
Age>=20 years
Written informed consent is obtained
Key exclusion criteria
Prestroke mRS score>=3
CT not taken at our hospital
Imaging of the previous hospital revealed large vessel occlusion
Endovascular therapy is contraindicated
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Saito |
Organization
Kohnan hospital
Division name
Department of Stroke Neurology
Zip code
9820012
Address
4-20-1 Nagamachi-minami, Taihaku-ku, Sendai 982-8523, Japan
TEL
022-248-2131
tsai10@kohnan-sendai.or.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Saito |
Organization
Kohan Hospital
Division name
Department of Stroke Neurology
Zip code
9820012
Address
4-20-1 Nagamachi-minami, Taihaku-ku, Sendai 982-8523, Japan
TEL
022-248-2131
Homepage URL
tsai10@kohnan-sendai.or.jp
Sponsor or person
Institute
Kohan Hospital
Institute
Department
Personal name
Funding Source
Organization
Kohan Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kohnan Hospital Ethics Committee
Address
4-20-1 Nagamachi-minami, Taihaku-ku, Sendai 982-8523, Japan
Tel
022-248-2131
mura919@kohnan-sendai.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
99
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 28 | Day |
Last modified on
| 2022 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046289
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
