UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000026075
Receipt number	R000029949
Scientific Title	Establishment of a method for evaluating endothelium-dependent hyperpolarization by concurrent use of FMD and RH-PAT accompanying brachial arterial administration of L-NMMA acetate and bradykinin acetate: a pilot study.
Date of disclosure of the study information	2017/02/15
Last modified on	2017/07/05 13:05:14

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Basic information

Public title

Establishment of a method for evaluating endothelium-dependent hyperpolarization by concurrent use of FMD and RH-PAT accompanying brachial arterial administration of L-NMMA acetate and bradykinin acetate: a pilot study.

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Not applicable.

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To confirm the safety of the method for evaluating endothelium-dependent hyperpolarization in healthy subjects.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase I

Assessment

Primary outcomes

Any adverse events during the examination.

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

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Diagnosis

Type of intervention

Medicine Device,equipment

Interventions/Control_1

(1)486 mg of aspirin is taken once orally.
(2)0.3 mg of nitroglycerin is taken once orally.
(3)L-NMMA acetate is administered at 8 micromol/min for 5 minutes from the brachial artery once.
(4)Bradykinin acetate is administered 3 times from the brachial artery at 25 ng/min, 50 ng/min, 100 ng/min for 2 minutes each.
(5)FMD(Flow-mediated dilation) is measured 4 times.
(6)RH-PAT (Reactive hyperemia-peripheral arterial tonometry) is measured 4 times.

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

Healthy subjects

Key exclusion criteria

(1) Those with coronary risk factors (smoking history, hypertension, dyslipidemia, hyperuricemia, diabetes)
(2) Those who take medications such as nitrites and calcium channel blockers.
(3) Obesity, emaciation (body mass index: less than 18.5, greater than 25)
(4) Those who have resting systolic blood pressure less than 100 mmHg or greather than 200 mmHg at the time of measurement of vascular endothelial function
(5) Those with arrhythmia such as atrial fibrillation
(6) Persons who have had aspirin asthma
(7) Others who judged that your doctor is inappropriate for participation in research
(8) Women who are pregnant, have a possibility of pregnancy, are within 28 days of childbirth, or who are breastfeeding
(9) Those who are judged to be difficult to participate in the trial by merging psychosis or psychiatric symptoms

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Hiroaki Shimokawa

Organization

Tohoku University Graduate School of Medicine.

Division name

Department of Cardiovascular Medicine

Zip code

Address

1-1 Seiryomachi, Aoba-ku, Sendai, Miyagi

TEL

0227177152

Email

shimo@cardio.med.tohoku.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name Shoko Kajitani

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code

Address

1-1 Seiryomachi, Aoba-ku, Sendai, Miyagi

TEL

0227177153

Homepage URL

Email

edh-factor@cardio.med.tohoku.ac.jp

Sponsor or person

Institute

Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine.

Institute

Department

Personal name

Funding Source

Organization

Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2017 Year 02 Month 15 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 02 Month 14 Day

Date of IRB

Anticipated trial start date

2017 Year 03 Month 01 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2017 Year 02 Month 09 Day

Last modified on

2017 Year 07 Month 05 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029949

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name