UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006847
Receipt number R000004310
Scientific Title Dilatation effect of Nitroglycerin spray through the skin for superficial arteries: the evaluation using ultrasonography (Basic research for the usefulness of Nitroglycerin spray in superficial artery cannulation.)
Date of disclosure of the study information 2011/12/06
Last modified on 2019/04/24 14:05:02

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Basic information

Public title

Dilatation effect of Nitroglycerin spray through the skin for superficial arteries: the evaluation using ultrasonography (Basic research for the usefulness of Nitroglycerin spray in superficial artery cannulation.)

Acronym

Local dilation effect of Nitroglycerin spray through the skin for superficial arteries.

Scientific Title

Dilatation effect of Nitroglycerin spray through the skin for superficial arteries: the evaluation using ultrasonography (Basic research for the usefulness of Nitroglycerin spray in superficial artery cannulation.)

Scientific Title:Acronym

Local dilation effect of Nitroglycerin spray through the skin for superficial arteries.

Region

Japan


Condition

Condition

healthy volunteers

Classification by specialty

Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We select 10 healthy volunteers randomly and evaluate the dilatation effect of Nitroglycerin spray through the skin for their brachial arteries using ultrasonography.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Local dilatation effect for brachial artery after skin spray of Nitroglycerin.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

We measure the cross sectional areas of brachial arteries of 10 subjects before and after spraying Nitroglycerin to the upper skin of the arteries. The period of intervention for each volunteer is one hour.

Interventions/Control_2

We measure the cross sectional areas of brachial arteries of 10 subjects before and after spraying saline to the upper skin of the arteries. The period of intervention for each volunteer is one hour.

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

22 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Healthy individuals

Key exclusion criteria

Individuals with vascular disease, hypotension, cardiac disease, renal hypofunction, primary pulmonary hypertension and abnormal laboratory data.
Pregnant woman and possibly pregnant woman.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo Awai

Organization

Hiroshima University Hospital

Division name

Department of Diagnostic Radiology

Zip code


Address

1-2-3 Kasumi, Minami-ku, Hiroshima 734-8553, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Keizo Tanitame

Organization

Hiroshima University Hospital

Division name

Department of Diagnostic Radiology

Zip code


Address


TEL


Homepage URL


Email

tntrad@ms1.megaegg.ne.jp


Sponsor or person

Institute

Department of Diagnostic Radiology, Hiroshima University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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


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

2011 Year 12 Month 06 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

2010 Year 05 Month 01 Day

Date of IRB

2010 Year 04 Month 01 Day

Anticipated trial start date

2010 Year 05 Month 01 Day

Last follow-up date

2010 Year 11 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 12 Month 06 Day

Last modified on

2019 Year 04 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004310


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name