UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063118 |
|---|---|
| Receipt number | R000072253 |
| Scientific Title | A Single-Center Prospective Interventional Pilot Study to Assess the Feasibility, Safety, and Change in Absolute Coronary Flow Before and After Percutaneous Coronary Intervention and Its Association With Clinical Outcomes |
| Date of disclosure of the study information | 2026/09/30 |
| Last modified on | 2026/09/30 14:15:22 |
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Basic information
Public title
A Single-Center Prospective Interventional Pilot Study to Assess the Feasibility, Safety, and Change in Absolute Coronary Flow Before and After Percutaneous Coronary Intervention and Its Association With Clinical Outcomes
Acronym
A Single-Center Prospective Interventional Pilot Study to Assess the Feasibility, Safety, and Change in Absolute Coronary Flow Before and After Percutaneous Coronary Intervention and Its Association With Clinical Outcomes
Scientific Title
A Single-Center Prospective Interventional Pilot Study to Assess the Feasibility, Safety, and Change in Absolute Coronary Flow Before and After Percutaneous Coronary Intervention and Its Association With Clinical Outcomes
Scientific Title:Acronym
A Single-Center Prospective Interventional Pilot Study to Assess the Feasibility, Safety, and Change in Absolute Coronary Flow Before and After Percutaneous Coronary Intervention and Its Association With Clinical Outcomes
Region
| Japan |
Condition
Condition
chronic coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, in addition to percutaneous coronary intervention (PCI) performed as part of routine clinical care, absolute coronary flow measurements will be performed before and after PCI for research purposes. The study aims to assess the feasibility of these measurements and to exploratorily investigate the associations between changes in coronary blood flow and clinical parameters at 1-year follow-up, including symptoms, cardiac function, and B-type natriuretic peptide (BNP) levels
Basic objectives2
Others
Basic objectives -Others
Assessment of changes in absolute coronary flow before and after PCI
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in absolute coronary flow (delta Absolute Flow) from before to after PCI. Absolute coronary flow (mL/min) will be measured before and after PCI, and the change between the two measurements will be evaluated.
Key secondary outcomes
1.Success rate of absolute coronary flow measurement before and after PCI.
2.Change in fractional flow reserve (FFR) from before to after PCI.
3.Association between delta Absolute Flow and the change in FFR.
4.Incidence of adverse events related to the absolute coronary flow measurement procedure.
5.Effect size and variance estimates of delta Absolute Flow for planning future confirmatory studies.
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
In addition to PCI performed as part of routine clinical care, absolute coronary flow will be measured before and after PCI for research purposes. Absolute coronary flow will be measured using a PressureWire X and RayFlow catheter by continuous thermodilution with continuous saline infusion.
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.Age 20 years or older at the time of enrollment.
2.Scheduled to undergo percutaneous coronary intervention (PCI) for coronary artery disease.
3.Considered eligible for participation in the study by the principal investigator or a study investigator.
4.Written informed consent has been obtained from the participant. If obtaining informed consent directly from the participant is difficult, written informed consent has been obtained from a legally 5.acceptable representative.
Key exclusion criteria
1.Hemodynamic instability.
2.Ostial coronary artery lesions.
3.Severe heart failure, significant arrhythmias, or cardiogenic shock.
4.Patients in whom the study procedure is considered to pose an increased risk.
5.Coronary anatomy unsuitable for absolute coronary flow measurement.
6.History of severe hypersensitivity reactions.
7.Severe renal impairment.
8.Pregnancy or possible pregnancy.
9.Any other condition considered inappropriate for participation by the principal investigator or a study investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hirohiko |
| Middle name | |
| Last name | Ando |
Organization
Aichi Medical University Hospital
Division name
Department of Cardiology
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi,Japan
TEL
0561-62-3311
anhiro@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirohiko |
| Middle name | |
| Last name | Ando |
Organization
Aichi Medical University Hospital
Division name
Department of Cardiology
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi,Japan
TEL
0561-62-3311
Homepage URL
anhiro@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University
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
Ethics Committee of Aichi Medical University School of Medicine
Address
1-1 Yazakokarimata, Nagakute, Aichi,Japan
Tel
0561-62-3311
amu_ethics@aichi-med-u.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 | 09 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 30 | Day |
Last modified on
| 2026 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072253
