UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041692 |
|---|---|
| Receipt number | R000047372 |
| Scientific Title | Optical Coherence Tomography for In vivo Detection of Layered Plaque: A prospective study |
| Date of disclosure of the study information | 2020/09/08 |
| Last modified on | 2024/03/08 11:24:37 |
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Basic information
Public title
Optical Coherence Tomography for In vivo Detection of Layered Plaque: A prospective study
Acronym
Optical Coherence Tomography for In vivo Detection of Layered Plaque: A prospective study
Scientific Title
Optical Coherence Tomography for In vivo Detection of Layered Plaque: A prospective study
Scientific Title:Acronym
Optical Coherence Tomography for In vivo Detection of Layered Plaque: A prospective study
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aims of the study are (1) to evaluate the prevalence and pattern of layered plaques both at culprit and non-culprit lesions using optical coherence tomography (OCT) in a prospective fashion, and (2) to identify biomarkers and microbiome specific for layered plaque to better understand the underlying pathobiology.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The aims of the study are (1) to evaluate the prevalence and pattern of layered plaques both at culprit and non-culprit lesions using optical coherence tomography (OCT) in a prospective fashion, and (2) to identify biomarkers and microbiome specific for layered plaque to better understand the underlying pathobiology.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with SAP or ACS who are undergoing catheterization would be eligible. ACS include ST elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction (NSTEMI), and unstable angina pectoris. When thrombus interferes with optimal OCT image acquisition, aspiration thrombectomy will be allowed.
Key exclusion criteria
- Previous revascularization at the culprit vessel
- Tortuous vessel
- Heavily calcified vessel
- Chronic Kidney Disease (estimated glomerular filtration rate < 30 mL/min per
1.73 m2)
- Cardiogenic shock
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Sunao |
| Middle name | |
| Last name | Nakamura |
Organization
New Tokyo Hospital
Division name
Interventional Cardiology Unit
Zip code
270-2232
Address
1271 Wanagaya, Matsudo, Chiba
TEL
047-711-8700
boss0606@pluto.plala.or.jp
Public contact
Name of contact person
| 1st name | Kazuna |
| Middle name | |
| Last name | Kobayashi |
Organization
New Tokyo Hospital
Division name
Clinical research center
Zip code
270-2232
Address
1271 Wanagaya, Matsudo, Chiba
TEL
047-711-8700
Homepage URL
k-kobayashi@shin-tokyohospital.or.jp
Sponsor or person
Institute
New Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Massachusetts General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board, New Tokyo Hospital
Address
1271 Wanagaya, Matsudo, Chiba
Tel
047-711-8700
re-committee@shin-tokyohospital.or.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
| 2020 | Year | 09 | Month | 08 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/36000423/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36000423/
Number of participants that the trial has enrolled
80
Results
Bacteria that were associated with vulnerable coronary plaque phenotype and greater plaque burden were identified. These bacteria were also associated with elevated inflammatory or prothrombotic biomarkers.
Results date posted
| 2024 | Year | 03 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who underwent both optical coherence tomography and intravascular ultrasound imaging and provided stool and blood specimens were included.
Participant flow
After informed consent is obtained, patients will undergo standard coronary angiography with or without PCI, which will be performed at the discretion of the interventionalist. In Japan, IVUS is performed in almost all PCI cases. OCT imaging of the target vessel will be performed prior to PCI. After the procedure, IVUS and OCT will be repeated.
Adverse events
none
Outcome measures
All OCT and IVUS images were submitted to the Massachusetts General Hospital core laboratory. OCT and IVUS image analysis was performed using offline review workstations (Ilumien Optis) (QCU CMS RESEARCH version 4.69, Leiden University Medical Center, Leiden, the Netherlands) by investigators who were blinded to the clinical, angiographic, and laboratory data.
The composition of gut microbiota was evaluated using 16S rRNA sequencing.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is designed as a prospective observational investigation. The data will be collected prospectively from a single site (New Tokyo Hospital, Chiba, Japan). One hundred patients undergoing clinically indicated cardiac catheterization will be enrolled. Informed consent will be obtained from each patient prior to the procedure. OCT imaging of the target vessel will be performed prior to intervention. Patient demographic information, angiograms, IVUS images and OCT images will be sent to Massachusetts General Hospital for analysis.
Management information
Registered date
| 2020 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047372
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