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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026075
Receipt No. 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

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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 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.
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.
Scientific Title:Acronym 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.
Region
Japan

Condition
Condition Not applicable.
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

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 1
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 5

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

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
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
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
URL(English) https://upload.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


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