UMIN-CTR Clinical Trial

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

Microvascular angina
Vasospastic angina

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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).

Study type

Interventional

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

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

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

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

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

Institute

Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine

Institute

Department

Personal name

Organization

MEXT

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東北大学病院（宮城県）

Date of disclosure of the study information

2017

Year

12

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

47

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

Recruitment status

Completed

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 related information

Registered date

2017

Year

12

Month

05

Day

Last modified on

2022

Year

01

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034467