UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056324 |
|---|---|
| Receipt number | R000064354 |
| Scientific Title | Incidence, clinical factors, and endotype characterization of coronary microvascular dysfunction in patients with nonobstructive coronary artery disease undergoing 13N-ammonia positron emission tomography |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2025/12/07 09:59:06 |
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Basic information
Public title
Incidence, clinical factors, and endotype characterization of coronary microvascular dysfunction in patients with nonobstructive coronary artery disease undergoing 13N-ammonia positron emission tomography
Acronym
Incidence, clinical factors, and endotype characterization of coronary microvascular dysfunction in patients with nonobstructive coronary artery disease undergoing 13N-ammonia positron emission tomography
Scientific Title
Incidence, clinical factors, and endotype characterization of coronary microvascular dysfunction in patients with nonobstructive coronary artery disease undergoing 13N-ammonia positron emission tomography
Scientific Title:Acronym
Incidence, clinical factors, and endotype characterization of coronary microvascular dysfunction in patients with nonobstructive coronary artery disease undergoing 13N-ammonia positron emission tomography
Region
| Japan |
Condition
Condition
patients with suspected or known coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Coronary microvascular dysfunction (CMD) is characterized by impaired myocardial flow reserve (MFR) and is thought to be closely related to angina or ischemia in patients with nonobstructive coronary artery disease (CAD). However, the real-world incidence of CMD, contributing risk factors for a decrease in MFR, and characteristics of the two CMD endotypes (endogen and classical CMD) in this population remain unclear. We investigated the prevalence of PET-assessed CMD in a clinical population and clarified the correlations between a decrease in MFR and significant clinical factors, including age, sex, symptoms, conventional cardiovascular disease risk factors, and PET-related parameters, to characterize distinct CMD endotypes based on PET flow data.
Basic objectives2
Others
Basic objectives -Others
Coronary microvascular dysfunction (CMD) is characterized by impaired myocardial flow reserve (MFR) and is thought to be closely related to angina or ischemia in patients with nonobstructive coronary artery disease (CAD). However, the real-world incidence of CMD, contributing risk factors for a decrease in MFR, and characteristics of the two CMD endotypes (endogen and classical CMD) in this population remain unclear. We investigated the prevalence of PET-assessed CMD in a clinical population and clarified the correlations between a decrease in MFR and significant clinical factors, including age, sex, symptoms, conventional cardiovascular disease risk factors, and PET-related parameters, to characterize distinct CMD endotypes based on PET flow data.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of CMD and identified clinical factors and PET-related parameters that were associated with a decrease in myocardial flow reserve (MFR).
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Consecutive individuals with clinical signs or symptoms of ischemic heart disease who underwent myocardial perfusion PET, between January 2017 and April 2024, at our institution.
Key exclusion criteria
We excluded 536 patients owing to prior documented myocardial infarction and/or coronary revascularization (n=434) [myocardial infarction (n=210), percutaneous coronary intervention (n=378), or coronary artery bypass grafting (n=93)], known cardiomyopathy (n=46), previous hospitalization for heart failure (n=22), left ventricular ejection fraction <30% (n=15), congenital heart disease (n=9), significant valvular heart disease (n=8), and missing data (n=2). Of the remaining 777 patients, 683 patients underwent anatomical coronary assessments via coronary computed tomography angiography (CCTA), invasive CAG, or both within 6 months of the PET examination; and we excluded 84 patients who did not undergo CCTA or CAG within the 6 months, and 10 patients with inadequate imaging qualities
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | SHIRO |
| Middle name | |
| Last name | MIURA |
Organization
Sapporo Kojinkai Memorial Hospital, Sapporo, Japan
Division name
Department of Cardiology
Zip code
063-0052
Address
Department of Cardiology, Sapporo Kojinkai Memorial Hospital 2-1-16-1 Miyanosawa, Nishi-ku, Sapporo 063-0052, Japan
TEL
08017135544
shirotan1027m@yahoo.co.jp
Public contact
Name of contact person
| 1st name | SHIRO |
| Middle name | |
| Last name | MIURA |
Organization
Sapporo Kojinkai Memorial Hospital
Division name
Department of Cardiology,
Zip code
0630052
Address
Department of Cardiology, Sapporo Kojinkai Memorial Hospital 2-1-16-1 Miyanosawa, Nishi-ku, Sapporo
TEL
08017135544
Homepage URL
shirotan1027m@yahoo.co.jp
Sponsor or person
Institute
Shiro Miura, Department of Cardiology, Sapporo Kojinkai Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiology, Sapporo Kojinkai Memorial Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB in Sapporo Kojinkai Memorial Hospital
Address
Department of Cardiology, Sapporo Kojinkai Memorial Hospital 2-1-16-1 Miyanosawa, Nishi-ku, Sapporo
Tel
011-665-0020
sugiya@sap-kojk.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
| 2024 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/40958571/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/40958571/
Number of participants that the trial has enrolled
345
Results
Independent predictors of decreased MFR included older age, female sex, anemia, and hypertension; however, these factors accounted for only 32% of the observed variability in MFR. Symptomatic status was not an independent predictor of decreased MFR. Patients with classical CMD (resting MBF <1.3 mL/min/g) had higher summed stress scores and stress/resting coronary vascular resistance,
Results date posted
| 2025 | Year | 12 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
After screening 1,313 patients with suspected or known CAD who underwent 13N-ammonia positron emission tomography (PET), 345 with non-obstructive CAD were retrospectively enrolled in the study. Stress/resting myocardial blood flow (MBF) was quantified using 13N-ammonia PET.
Participant flow
After screening 1,313 patients with suspected or known CAD who underwent 13N-ammonia positron emission tomography (PET), 345 with non-obstructive CAD were retrospectively enrolled in the study. Stress/resting myocardial blood flow (MBF) was quantified using 13N-ammonia PET.
Adverse events
Not defined.
Outcome measures
Not defined.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 02 | Month | 06 | Day |
Date trial data considered complete
| 2025 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 05 | Month | 26 | Day |
Other
Other related information
This is a retrospective observational study. It aims to report descriptive findings, not to focus on the outcome data.
We investigate the prevalence of PET-assessed CMD in a clinical population and clarify the correlations between a decrease in MFR and significant clinical factors, including age, sex, symptoms, conventional cardiovascular disease risk factors, and PET-related parameters, to characterize distinct CMD endotypes based on PET flow data.
Management information
Registered date
| 2024 | Year | 12 | Month | 01 | Day |
Last modified on
| 2025 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064354
