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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034174
Receipt No. R000038955
Scientific Title Investigation for optimal protocol using diluted ionic contrast medium during angiography
Date of disclosure of the study information 2018/09/26
Last modified on 2019/03/19

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Basic information
Public title Investigation for optimal protocol using diluted ionic contrast medium during angiography
Acronym Diluted ionic contrast medium during angiography
Scientific Title Investigation for optimal protocol using diluted ionic contrast medium during angiography
Scientific Title:Acronym Diluted ionic contrast medium during angiography
Region
Japan

Condition
Condition arterial diseases
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the optimal protocol using diluted ionic contrast medium during angiography
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy of diluted ionic contrast medium during endovascular treatment for arterial diseases
Key secondary outcomes Effect of diluted contrast medium on kidney function

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
Medicine
Interventions/Control_1 During the endovascular treatment for arterial diseases, angiogram using diluted ionic contrast medium will be performed
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 Any patient over 20 years old, who will be receiving endovascular treatment using ionic contrast medium, and has given written consent to participate to the study
Key exclusion criteria 1) Patients allergic to ionic contrast medium
2) End stage renal insufficiency (eGFR < 15 ml/min) contraindicated to any ionic contrast medium
3) Patients determined to be unfit to participate the study by the attending physician. (for example, dementia)
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Naoki
Middle name
Last name Fujimura
Organization Saiseikai Central Hospital
Division name Cardiovascular Surgery
Zip code 108-0073
Address 1-4-17, Mita, Minato-ku, Tokyo
TEL 03-3451-8211
Email naokif0212@gmail.com

Public contact
Name of contact person
1st name Naoki
Middle name
Last name Fujimura
Organization Saiseikai Central Hospital
Division name Cardiovascular Surgery
Zip code 1080073
Address 1-4-17 Mita, Minato, Tokyo, Japan
TEL 03-3451-8211
Homepage URL
Email naokif0212@gmail.com

Sponsor
Institute Saisekai Central Hospital
Institute
Department

Funding Source
Organization Self funding
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 Saisekai Central Hospital
Address 1-4-17 Mita, Minatoku, Tokyo, Japan
Tel 03-3451-8211
Email tikenjimu@saichu.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
2018 Year 09 Month 26 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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 01 Day
Date of IRB
2018 Year 07 Month 18 Day
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
2020 Year 12 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
2018 Year 09 Month 17 Day
Last modified on
2019 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038955

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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