UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039991 |
|---|---|
| Receipt number | R000045560 |
| Scientific Title | Continuous glucose monitoring for acute ischemic stroke patients after mechanical thrombectomy |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2021/04/02 04:17:48 |
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Basic information
Public title
Continuous glucose monitoring for acute ischemic stroke patients after mechanical thrombectomy
Acronym
CONFIRM study
Scientific Title
Continuous glucose monitoring for acute ischemic stroke patients after mechanical thrombectomy
Scientific Title:Acronym
CONFIRM study
Region
| Japan |
Condition
Condition
Acute ischemic stroke patients
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To address the relationships between glucose profile after mechanical thrombectomy obtained by continuous glucose monitoring and clinical outcomes
Basic objectives2
Others
Basic objectives -Others
relationship
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
modified Rankin Scale at 90 days after onset
Key secondary outcomes
Symptomatic intracranial hemorrhage within 90 days
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Acute ischemic stroke patients treated with mechanical thrombectomy
Age>=6 years
Written informed consent is obtained
Key exclusion criteria
Recuiring MRI within 72 hours after mechanical thrombectomy
Physician judged that participation in this study was inappropriate
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yukako |
| Middle name | |
| Last name | Yazawa |
Organization
Kohnan Hospital
Division name
Department of Stroke Neurology
Zip code
9828523
Address
4-20-1 Nagamachi-minami, Taihaku-ku, Sendai 982-8523, Japan
TEL
022-248-2131
yazawa@kohnan-sendai.or.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Saito |
Organization
Kohnan Hospital
Division name
Department of Stroke Neurology
Zip code
9828523
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
Kohnan Hospital
Institute
Department
Personal name
Funding Source
Organization
Kohnan 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
nagamine@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 | 04 | Month | 01 | 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
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
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Consecutive patients with acute ischemic stroke treated with mechanical thrombectomy in the Kohnan Hospital from April 2020 to march 2021 and who met the selection criteria
Glucose parameters such as maximum, minimum, mean, standard deviation, mean amplitude, area under the curve, distribution time
Management information
Registered date
| 2020 | Year | 03 | Month | 31 | Day |
Last modified on
| 2021 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045560
