UMIN-CTR Clinical Trial

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
Email	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
Email	tsai10@kohnan-sendai.or.jp

Sponsor
Institute	Kohnan Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045560