UMIN-CTR Clinical Trial

Basic information
Public title	Sex difference in coronary vasomotor function of the patients with ischemia and no obstructive coronary artery (INOCA)
Acronym	Sex difference in coronary vasomotor function of the patients with ischemia and no obstructive coronary artery (INOCA)
Scientific Title	Sex difference in coronary vasomotor function of the patients with ischemia and no obstructive coronary artery (INOCA)
Scientific Title:Acronym	Sex difference in coronary vasomotor function of the patients with ischemia and no obstructive coronary artery (INOCA)
Region	Japan

Condition
Condition	ischemia and no obstructive coronary artery (INOCA)
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate sex differences in the regulation of coronary circulation and the cause for the differences.
Basic objectives2	Others
Basic objectives -Others	To elucidate sex differences in the regulation of coronary circulation and the cause for the differences.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Sex difference in prevalence and combination of endotypes of coronary functional disorder (e.g. epicardial spasm, microvascular spasm, impaired microvascular diastolic function)
Key secondary outcomes	1) Sex difference in serum levels of endothelin-1, high-sensitive estradiol, and Rho-kinase activity. 2) Sex difference in endothelial and/or vascular smooth muscle functions of isolated resistance vessels by performing isometric tension measurement experiments. 3) Sex difference in the effect of usual therapy for INOCA patients

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	1) Patients suspected of INOCA who is scheduled to undergo cardia catheterization 2) Patients aged 20 or over who could give informed consent
Key exclusion criteria	1) Patients with a significant organic stenosis (AHA classification over 75% luminal stenosis) in coronary arteries 2) ACS patients 3) Patients with severe kidney disease 4) Patients with a history of severe BA attack 5) Patients with a history of allergy of contrast agent 6) Patients with a history of allergy of acetylcholine 7) Patients who is identified as appropriate in a subject of this study by an attending physician
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name Takahashi
Organization	Tohoku university graduate school of medicine
Division name	Department of cardiovascular medicine
Zip code	980-8574
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL	022-717-7153
Email	jtakahashi@cardio.med.tohoku.ac.jp

Public contact
Name of contact person	1st name Jun Middle name Last name Takahashi
Organization	Tohoku university graduate school of medicine
Division name	Department of cardiovascular medicine
Zip code	980-8574
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL	022-717-7153
Homepage URL
Email	jtakahashi@cardio.med.tohoku.ac.jp

Sponsor
Institute	Japan Agency for Medical Research and Development
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethical review board of Tohoku university hospital
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
Tel	022-728-4105
Email	ec@rinri.hosp.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）、国立循環器病研究センター（大阪府）

Other administrative information
Date of disclosure of the study information	2021 Year 10 Month 28 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	Preinitiation
Date of protocol fixation	2021 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date	2021 Year 11 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

More than on-half of CCS patients have ischemia and no obstructive coronary artery (INOCA), which is particularly common in women. In women, menopause increases arteriosclerosis risks such as hypertension, hyperlipidemia, obesity and diabetes. Furthermore, menopause also reduces vascular protective effects of estrogen including endothelium-dependent and/or independent vasorelaxation, and antiproliferative activity of vascular smooth muscle cells, which result in the development of atherosclerosis. However, sex differences in the regulation of coronary circulation and the cause for the differences remain to be elucidated. The aim of this study is to elucidate the following unsolved issues; 1) What is female-specific or male-specific feature in coronary vasomotor dysfunction in the patients with INOCA? 2) What is the mechanism responsible for the development of sex difference in coronary vasomotor dysfunction? 3) Are there sex differences in endothelial and/or vascular smooth muscle dysfunction of resistance vessels isolated from INOCA patients? Then, in this study, we will evaluate 1) prevalence and combination of endotypes of coronary functional disorder (e.g. epicardial spasm, microvascular spasm, impaired microvascular diastolic function), 2) serum levels of endothelin-1, high-sensitive estradiol, and Rho-kinase activity, and 3) endothelial and/or vascular smooth muscle functions of isolated resistance vessels by performing isometric tension measurement experiments. By analyzing above study points in terms of sex difference, we aim at identifying the characteristics of female coronary vasomotor dysfunction in INOCA.

Management information
Registered date	2021 Year 10 Month 24 Day
Last modified on	2021 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052340