UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056462 |
|---|---|
| Receipt number | R000064519 |
| Scientific Title | The association between angiographically derived radial wall strain and the risk of plaque rupture |
| Date of disclosure of the study information | 2025/01/20 |
| Last modified on | 2024/12/15 13:47:06 |
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Basic information
Public title
The association between radial wall strain and plaque rupture
Acronym
The association between coronary strain and plaque rupture
Scientific Title
The association between angiographically derived radial wall strain and the risk of plaque rupture
Scientific Title:Acronym
The association between radial wall strain and plaque rupture
Region
| Japan |
Condition
Condition
Acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aimed to investigate the impact of radial wall strain (RWS) to plaque rupture, by analyzing RWS from index coronary andigography (CAG) of the patients who developed acute coronary syndrome (ACS) and underwent percutaneous coronary intervention (PCI) with optical coherence tomography (OCT).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
RWS analized from index CAG in culprit lesions developing ACS with plaque rupture, and non-culprit lesions
Key secondary outcomes
RWS analysed from index CAG between plaque rupture, plaque erosion and calcified nodule, in culprit lesions
Perioperative complication (distal embolization, slow flow/no reflow, intrastent plaque/thrombus protrusion and perioperative myocardial infarction) in PCI for culprit lesions.
Major cardiac adverce events (target lesion revascularization, target vessel-related myocardial infarction and cardiac death) in culprit lesions.
Major cardiac adverce events (non-culprit lesion related revascularization, non-culprit vessel-related myocardial infarction and cardiac death) in non-culprit lesions.
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
Patients whose OCT are available for assessment of plaque morphology
Patients who had underwent index CAG
Patients who had at least 1 de novo native coronary lesion
Patients aged 20 years or older at index CAG
Lesions with a percent diameter stenosis of 30% to 70% from quantitative coronary angiography (QCA) assessment
Lesions with reference vessel diameter 2.0 mm or more by QCA assessment
Key exclusion criteria
Lesions of in-stent restenosis within 5 mm from stent edges
Lesions with a left main coronary artery location
Lesions with a distance of < 5 mm from the vessel ostium
Lesions with previous coronary artery bypass grafting of the target vessel
Lesions with difficulty in RWS analysis
Lesions underwent revascularization, based on index CAG,before second-time CAG
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Otake |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5111
hotake@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromasa |
| Middle name | |
| Last name | Otake |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5111
Homepage URL
hotake@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
The Ethics Committee of Kobe University Hospital
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Tel
078-382-5846
kansatsu@med.kobe-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
| 2025 | Year | 01 | Month | 20 | 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
| 2025 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 20 | 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
None
Management information
Registered date
| 2024 | Year | 12 | Month | 15 | Day |
Last modified on
| 2024 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064519
