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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030269
Receipt No. R000034467
Scientific Title Assessment of endothelium-dependent hyperpolarization in patients with microvascular and/or vasospastic angina
Date of disclosure of the study information 2017/12/15
Last modified on 2021/06/08

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Basic information
Public title Assessment of endothelium-dependent hyperpolarization in patients with microvascular and/or vasospastic angina
Acronym Assessment of endothelium-dependent hyperpolarization in patients with microvascular and/or vasospastic angina
Scientific Title Assessment of endothelium-dependent hyperpolarization in patients with microvascular and/or vasospastic angina
Scientific Title:Acronym Assessment of endothelium-dependent hyperpolarization in patients with microvascular and/or vasospastic angina
Region
Japan

Condition
Condition Microvascular angina
Vasospastic angina
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to examine the roles of EDH in patients with microvascular and/or vasospastic angina.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Endothelial functions as evaluated by FMD (flow-mediated dilation) and RH-PAT (reactive hyperemia-peripheral arterial tonometry).
Key secondary outcomes Endothelial function-related biomarkers such as NOx, adiponectin, Rho-kinase activity, ADMA (asymmetric dimethylarginine).

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
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 Aspirin 486 mg; L-NMMA acetate 8 micromol/min for 5 minutes; bradykinin acetate 25 ng/min, 50 ng/min and 100 ng/min for 2 minutes each, 3 times; nitroglycerin 0.3 mg sublingual administration.
Four times measurement of FMD and RH-PAT.
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 ・Patients who are hospitalized for being suspected microvascular and/or coronary vasospastic angina by catheterization, or our outpatients diagnosed with microvascular and/or coronary vasospastic angina.
・Regardless of gender.
Key exclusion criteria ・Patients in hospital due to acute coronary syndrome.
・Patients with cardiogenic shock or heart failure.
・Patients with end-stage renal failure with internal shunt.
・Patients taking continuous intravenous infusion of cardiovascular agents such as inotropes and vasodilators.
・Patients who have resting systolic blood pressure below 100 mmHg or more than 200mmHg at the time of measurement of endothelial functions.
・Patients who have arrhythmia such as atrial fibrillation and are considered to be difficult to measure vascular endothelial function.
・Patients with a history of aspirin asthma.
・Patients who are taking any antithrombotic therapies except single antiplatelet agent.
・Patients who are pregnant or have a possibility of pregnancy, and who are falling within 28 days after childbirth or breast-feeding
・Patients are considered to be difficult to participate in the trial due to mental illness or psychiatric symptoms.
・Patients who are judged to be inappropriate for participating in the study by us.
Target sample size 130

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Shimokawa
Organization Tohoku University Graduate School of Medicine
Division name Cardiovascular Medicine
Zip code 9800872
Address 1-1, Seiryomachi, Aoba-ku, Sendai, Miyagi
TEL 0227177153
Email shoko_k0520@cardio.med.tohoku.ac.jp

Public contact
Name of contact person
1st name Shoko
Middle name
Last name Kajitani
Organization Tohoku University Graduate School of Medicine
Division name Cardiovascular Medicine
Zip code 9800872
Address 1-1, Seiryomachi, Aoba-ku, Sendai, Miyagi
TEL 0227177153
Homepage URL
Email shoko_k0520@cardio.med.tohoku.ac.jp

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

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
Address Seiryomachi, Aoba-ku, Sendai, Miyagi
Tel 0227177153
Email rinri-2@proj.med.tohoku.ac.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 東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 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 We measured FMD and RHI to 47 patients.
Results date posted
2019 Year 12 Month 07 Day
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
2017 Year 12 Month 08 Day
Date of IRB
2017 Year 12 Month 10 Day
Anticipated trial start date
2017 Year 12 Month 20 Day
Last follow-up date
2022 Year 12 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 05 Day
Last modified on
2021 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034467

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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