UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050284 |
|---|---|
| Receipt number | R000057090 |
| Scientific Title | Feasibility of intracoronary high-frequency optical coherence tomography imaging using Ringer's solution as an alternative flushing agent |
| Date of disclosure of the study information | 2023/02/17 |
| Last modified on | 2023/02/17 15:50:21 |
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Basic information
Public title
Feasibility of intracoronary high-frequency optical coherence tomography imaging using Ringer's solution as an alternative flushing agent
Acronym
Intracoronary high-frequency optical coherence tomography imaging using Ringer's solution
Scientific Title
Feasibility of intracoronary high-frequency optical coherence tomography imaging using Ringer's solution as an alternative flushing agent
Scientific Title:Acronym
Intracoronary high-frequency optical coherence tomography imaging using Ringer's solution
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the feasibility of intracoronary fast-pullback high-frequency optical coherence tomography (HF-OCT) imaging using Ringer's solution as a flushing media alternative to a contrast agent.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The longitudinal length of analyzable OCT images (Non-inferiority of Ringer's solution-based OCT imaging compared to contrast-based OCT)
Key secondary outcomes
Qualitative and quantitative OCT analysis, adverse events during the OCT image acquisition.
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
1. Patients scheduled for OCT imaging
2. Age20 >=years old
3. Obtained informed consent
Key exclusion criteria
1. Decompensated heart failure or at high risk of decompensated heart failure
2. Ectatic coronary arteries
3. Severe tortuosity or calcification
4. Massive thrombosis
5. No adequate coronary flow for OCT image acquisition
6. Poor OCT images
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Teruyoshi |
| Middle name | |
| Last name | Kume |
Organization
Kawasaki Medical School
Division name
Department of Cardiology
Zip code
701-0192
Address
577 Matsushima, Kurashiki, Okayama, Japan
TEL
0864621111
tteru@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Nishi |
Organization
Kawasaki Medical School
Division name
Department of Cardiology
Zip code
701-0192
Address
577 Matsushima, Kurashiki, Okayama, Japan
TEL
0864621111
Homepage URL
takeshi24@hotmail.co.jp
Sponsor or person
Institute
Department of Cardiology, Kawasaki Medical SchoolKawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Unrestricted research grant at Kawasaki Medical School
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
577 Matsushima, Kurashiki, Okayama, Japan
Tel
0864641076
kmsrec@med.kawasaki-m.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
| 2023 | Year | 02 | Month | 17 | 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
| 2023 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2023 | Year | 02 | Month | 09 | Day |
Last modified on
| 2023 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057090
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| Registered date | File name |
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| Registered date | File name |
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