UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034174
Receipt number 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 2023/09/21 15:31:47

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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 or person

Institute

Saisekai Central Hospital

Institute

Department

Personal name



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

37

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

No longer 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

2023 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

2023 Year 09 Month 21 Day



Link to view the page

Value
https://center6.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