UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061710 |
|---|---|
| Receipt number | R000070583 |
| Scientific Title | Association of Hematological Inflammatory Indices With Coronary Microvascular Dysfunction Endotypes in Patients With Angina and Non-Obstructive Coronary Arteries: A Retrospective Observational Study |
| Date of disclosure of the study information | 2026/05/27 |
| Last modified on | 2026/05/27 21:12:33 |
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Basic information
Public title
Hematological Inflammatory Indices and Coronary Microvascular Endotypes in Patients with Angina and Non-Obstructive Coronary Arteries
Acronym
Hematological Inflammatory Indices and Coronary Microvascular Endotypes in Patients with Angina and Non-Obstructive Coronary Arteries
Scientific Title
Association of Hematological Inflammatory Indices With Coronary Microvascular Dysfunction Endotypes in Patients With Angina and Non-Obstructive Coronary Arteries: A Retrospective Observational Study
Scientific Title:Acronym
Association of Hematological Inflammatory Indices With Coronary Microvascular Dysfunction Endotypes in Patients With Angina and Non-Obstructive Coronary Arteries: A Retrospective Observational Study
Region
| Japan |
Condition
Condition
Angina with Non-Obstructive Coronary Arteries
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the association between hematological inflammatory indices and ANOCA phenotypes, including coronary microvascular dysfunction and coronary vasospasm, in patients with angina and non-obstructive coronary arteries. In particular, this study will examine whether monocyte-dominant inflammatory markers, such as the monocyte-to-lymphocyte ratio and monocyte-to-hematocrit ratio, are associated with structural coronary microvascular dysfunction defined by coronary flow reserve and the index of microcirculatory resistance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome measure is the association between hematological inflammatory indices and ANOCA phenotypes, including structural CMD, functional CMD, isolated IMR elevation, vasospastic angina, and microvascular spasm. CMD endotypes are defined according to CFR and IMR, while vasospastic angina and microvascular spasm are diagnosed by acetylcholine provocation testing.
Key secondary outcomes
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
Patients who underwent coronary angiography, acetylcholine spasm provocation testing, and comprehensive coronary physiological assessment of the left anterior descending artery as part of the diagnostic evaluation for chest pain or angina symptoms associated with chronic coronary syndrome at Tsuchiura Kyodo General Hospital. Patients without functionally significant coronary artery stenosis, defined as FFR >0.80, are included.
Key exclusion criteria
Patients with acute coronary syndrome, those undergoing hemodialysis, those with incomplete physiological or laboratory data, and those with poor pressure waveform quality are excluded.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tsunekazu |
| Middle name | |
| Last name | Kakuta |
Organization
Tsuchiura Kyodo General Hospital
Division name
Department of Cardiovascular Medicine
Zip code
300-0028
Address
4-1-1, Otsuno, Tsuchiura, Ibaraki, Japan
TEL
+81-29-830-3711
kaz@joy.email.ne.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Watanabe |
Organization
Tsuchiura Kyodo General Hospital
Division name
Department of Cardiovascular Medicine
Zip code
300-0028
Address
4-1-1, Otsuno, Tsuchiura, Ibaraki, Japan
TEL
+81-29-830-3711
Homepage URL
twatanabe.cvm@gmail.com
Sponsor or person
Institute
Tsuchiura Kyodo General Hospital
Institute
Department
Personal name
Funding Source
Organization
No specific funding
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
Institutional Review Board, Tsuchiura Kyodo General Hospital
Address
4-1-1, Otsuno, Tsuchiura, Ibaraki, Japan
Tel
+81-29-830-3711
general@tkgh.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 27 | 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
200
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
| 2026 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center, retrospective, observational study. Patients who underwent coronary angiography, acetylcholine spasm provocation testing, and comprehensive coronary physiological assessment of the left anterior descending artery for the evaluation of chest pain or angina symptoms between September 2022 and November 2025 are included. Among patients without functionally significant coronary artery stenosis, defined as FFR >0.80, those with chronic coronary syndrome are analyzed. Patients with acute coronary syndrome, those undergoing hemodialysis, those with incomplete physiological or laboratory data, and those with poor pressure waveform quality are excluded. Routinely collected clinical data, hematological parameters, coronary physiological indices, and acetylcholine provocation test results are used to evaluate the association between hematological inflammatory indices and ANOCA phenotypes.
Management information
Registered date
| 2026 | Year | 05 | Month | 27 | Day |
Last modified on
| 2026 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070583
