UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059382 |
|---|---|
| Receipt number | R000067918 |
| Scientific Title | Automatic vs Manual Bolus Injection for Thermodilution Assessing Coronary Microvascular Disease |
| Date of disclosure of the study information | 2025/10/14 |
| Last modified on | 2025/10/13 20:16:34 |
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Basic information
Public title
Automatic vs Manual Bolus Injection for Thermodilution Assessing Coronary Microvascular Disease
Acronym
The AMBITION-CMD Pilot Study
Scientific Title
Automatic vs Manual Bolus Injection for Thermodilution Assessing Coronary Microvascular Disease
Scientific Title:Acronym
The AMBITION-CMD Pilot Study
Region
| Japan |
Condition
Condition
Angina with nonobstructive coronary arteries
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the reproducibility of manual saline injection thermodilution and automatic thermodilution using the Arcatena injection system in patients suspected of angina with nonobstructive coronary arteries (ANOCA).
Basic objectives2
Others
Basic objectives -Others
NA
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the variability in coronary flow reserve (CFR) between two measurements obtained using automatic versus manual saline injection.
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
1) Patients with symptoms suggestive of angina.
2) Patients without epicardial coronary artery stenosis greater than 50%.
3) Patients suspected of having ANOCA based on criteria 1) and 2), who are scheduled to undergo invasive coronary physiological assessment.
4) Patients aged 20 years or older at the time of consent, regardless of sex.
5) Patients (or legally authorized representatives) who have received a full explanation of the study and have provided written informed consent of their own free will.
Key exclusion criteria
1) Patients with decompensated heart failure.
2) Patients with a history of coronary artery bypass grafting (CABG).
3) Patients with significant valvular heart disease requiring surgical or percutaneous intervention.
4) Patients with coronary anatomy in which guidewire passage is expected to be difficult due to severe tortuosity or other anatomical reasons.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Katagiri |
Organization
Sapporo Higashi Tokushukai Hospital
Division name
Department of Cardiology
Zip code
065-0033
Address
3-1, Kita 33-jo Higashi 14-chome, Higashi-ku, Sapporo, Japan
TEL
011-722-1110
ykatagiri.ggl@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Katagiri |
Organization
Sapporo Higashi Tokushukai Hospital
Division name
Department of Cardiology
Zip code
065-0033
Address
3-1, Kita 33-jo Higashi 14-chome, Higashi-ku, Sapporo, Japan
TEL
011-722-1110
Homepage URL
ykatagiri.ggl@gmail.com
Sponsor or person
Institute
Department of Cardiology, Sapporo Higashi Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
The Tokushukai Group Ethics Committee
Address
Tokyodo Chiyoda Bldg. 15F, 1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan
Tel
+81-3-3263-4801
irb@mirai-iryo.com
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
札幌東徳洲会病院（北海道）、イムス札幌消化器中央総合病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 10 | Month | 13 | Day |
Last modified on
| 2025 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067918
