UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032938
Receipt number R000037551
Scientific Title Usefulness of perfusion measurement using C-arm angiography device in acute stage cerebral infarction
Date of disclosure of the study information 2018/06/11
Last modified on 2023/06/14 00:53:08

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Basic information

Public title

Usefulness of perfusion measurement using C-arm angiography device in acute stage cerebral infarction

Acronym

Usefulness of perfusion measurement using C-arm angiography device in acute stage cerebral infarction

Scientific Title

Usefulness of perfusion measurement using C-arm angiography device in acute stage cerebral infarction

Scientific Title:Acronym

Usefulness of perfusion measurement using C-arm angiography device in acute stage cerebral infarction

Region

Japan


Condition

Condition

Acute stage cerebral infarction

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Endovascular treatment for acute stage cerebral infarction is performed using a C-arm angiography device in an angiography room. Conventionally, in order to confirm image diagnosis prior to intravascular treatment and confirm the success or failure of treatment, it was necessary for the patient to move from the cerebral vascular treatment room to the examination room etc. and photograph the CT perfusion image or SPECT. The purpose of this study is to verify that it is useful for improving patient prognosis and treatment process by shooting a perfusion image using a C-arm angiography device in intravascular treatment for acute stage cerebral infarction is there.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Main evaluation item MRI image is used as a reference and the C-arm perfusion image is evaluated and the ASPECTS score is compared

Key secondary outcomes



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

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Acquire C arm perfusion image

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

(1) Patients who undergo cerebrovascular examination and cerebrovascular treatment depending on medical necessity (2) If consent of participation of research by free will, if not sufficient for consent of the principal or the principal, from the substitute person in writing Patient acquired (3) Age: over 20 years old (4) Gender: no questions (5) different from outpatient outpatient: no question

Key exclusion criteria

(1) Patients with moderate or higher renal dysfunction (eGFR <45 ml / min / 1.73 m 2) (2) Patients who are predictive of allergy by contrast agent (3) Other patients who are deemed inappropriate by a doctor

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichi Yoshimmura

Organization

Hyogo College of Medicine

Division name

Neurosurgery

Zip code


Address

1-1 Mukogawa, Nishinomiya, Hyogo, Japan

TEL

0798-45-6458

Email

s-yoshi@hyo-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazutaka Uchida

Organization

Hyogo College of Medicine

Division name

Neurosurgery

Zip code


Address

1-1 Mukogawa, Nishinomiya, Hyogo, Japan

TEL

0798-45-6458

Homepage URL


Email

kuchidans@yahoo.co.jp


Sponsor or person

Institute

Hyogo College of Medicine

Institute

Department

Personal name



Funding Source

Organization

siemens-healthineers

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 Year 06 Month 11 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

2017 Year 05 Month 01 Day

Date of IRB

2017 Year 05 Month 10 Day

Anticipated trial start date

2017 Year 05 Month 30 Day

Last follow-up date

2021 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 06 Month 10 Day

Last modified on

2023 Year 06 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037551


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name