UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062588 |
|---|---|
| Receipt number | R000071642 |
| Scientific Title | A Prospective Exploratory Study Comparing Continuous and Conventional Bolus Thermodilution for Coronary Physiological Assessment in Patients With Angina and Non-Obstructive Coronary Arteries |
| Date of disclosure of the study information | 2026/08/25 |
| Last modified on | 2026/08/16 15:40:45 |
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Basic information
Public title
Comparison of coronary microvascular function assessment using continuous and conventional thermodilution in patients with angina and non-obstructive coronary arteries
Acronym
MATCH-ANOCA Study
Scientific Title
A Prospective Exploratory Study Comparing Continuous and Conventional Bolus Thermodilution for Coronary Physiological Assessment in Patients With Angina and Non-Obstructive Coronary Arteries
Scientific Title:Acronym
MATCH-ANOCA
Region
| Japan |
Condition
Condition
Angina with Non-Obstructive Coronary Arteries (ANOCA)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to prospectively compare coronary flow reserve and microvascular resistance measured by conventional bolus thermodilution and continuous thermodilution using the RayFlow catheter in patients with suspected angina with non-obstructive coronary arteries (ANOCA), and to assess the agreement and differences between the two methods in diagnosing microvascular angina according to the COVADIS criteria. The study will also explore associations among vasospastic endotypes identified by acetylcholine provocation testing, coronary microvascular flow-resistance phenotypes, and clinical symptoms.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Agreement and discordance in the classification of coronary microvascular dysfunction between conventional bolus thermodilution (CFR and IMR) and continuous thermodilution using the RayFlow catheter (CFRabs, MRR, and Rmicro), based on paired measurements obtained in the left anterior descending coronary artery during the index catheterization. Agreement will be evaluated across multiple candidate thresholds derived from previous studies using overall percentage agreement and the Cohen kappa coefficient with 95 percent confidence intervals.
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
All participants will undergo coronary angiography, conventional bolus thermodilution for measurement of CFR and IMR, and acetylcholine provocation testing as standard clinical care. As an additional research procedure, after completion of acetylcholine provocation testing and intracoronary nitroglycerin administration, continuous thermodilution will be performed once in the left anterior descending coronary artery using the RayFlow catheter and a pressure and temperature sensor guidewire. Room temperature normal saline will be infused at 10 mL/min for 60 seconds and then at 20 mL/min for 60 seconds. Qrest, Qhyper, Rmicro, CFRabs, and MRR will be calculated. Where feasible, ACh-CFR and ACh-IMR will also be measured during clinically indicated acetylcholine provocation testing using the guidewire already in place, without any additional device or drug administration.
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 aged 20 years or older.
2. Patients with angina or angina-equivalent symptoms in whom ANOCA is suspected.
3. Patients without severe stenosis on coronary angiography, or patients with intermediate stenosis in whom flow-limiting epicardial coronary disease is excluded by an FFR greater than 0.80 or a negative iFR.
4. Patients for whom acetylcholine provocation testing and invasive coronary physiological assessment are considered clinically appropriate as part of routine clinical care.
5. Patients able to provide written informed consent to participate in the study.
Key exclusion criteria
1. Acute coronary syndrome, cardiogenic shock, or hemodynamic instability.
2. Left main coronary artery disease, significant coronary stenosis with an FFR of 0.80 or less, or severe coronary stenosis for which revascularization should take priority.
3. High-grade atrioventricular block, clinically significant bradyarrhythmia, uncontrolled tachyarrhythmia, or another condition that raises safety concerns regarding acetylcholine or adenosine or ATP provocation, unless the treating physician considers the procedure safe, such as in a patient with an implanted pacemaker.
4. Severe asthma or any contraindication to adenosine or ATP administration.
5. An eGFR below 30 mL/min/1.73 m2, contrast medium allergy, current pregnancy, or possible pregnancy.
6. Severe left ventricular dysfunction, severe valvular heart disease, decompensated heart failure, or a serious comorbidity associated with a life expectancy of less than 1 year.
7. A target vessel considered too small for safe insertion of a pressure-temperature sensor wire or RayFlow catheter.
8. Any other condition considered unsuitable for study participation by the principal investigator or a subinvestigator.
9. Inability to provide written informed consent for study participation.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Hoshino |
Organization
Institute of Science Tokyo Hospital
Division name
Department of cardiovascular medicine
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
0338136111
hoshino.masahiro@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Hoshino |
Organization
Institute of Science Tokyo Hospital
Division name
Department of cardiovascular medicine
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
0338136111
Homepage URL
hoshino.masahiro@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Masahiro Hoshino
Funding Source
Organization
TERUMO LIFE SCIENCE FOUNDATION
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Fukuda Foundation for Medical Technology
Okinaka Memorial Institute for Medical Research
IRB Contact (For public release)
Organization
Institutional Review Board, Institute of Science Tokyo Hospital
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-4547
rinri.adm@tmd.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 25 | 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
| 2026 | Year | 08 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2029 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective, single-center observational study enrolling consecutive patients with suspected ANOCA. Coronary microvascular physiological indices obtained by bolus thermodilution and continuous thermodilution using the RayFlow catheter will be compared to evaluate agreement in the classification of coronary microvascular dysfunction and the characteristics of discordant cases. No treatment is assigned by the study.
Management information
Registered date
| 2026 | Year | 08 | Month | 16 | Day |
Last modified on
| 2026 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071642
