UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045846 |
|---|---|
| Receipt number | R000052340 |
| Scientific Title | Sex difference in coronary vasomotor function of the patients with ischemia and no obstructive coronary artery (INOCA) |
| Date of disclosure of the study information | 2021/10/28 |
| Last modified on | 2021/10/28 20:42:10 |
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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
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
jtakahashi@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052340
