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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045560


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name