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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041692
Receipt No. 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 2020/09/08

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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 NO

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
Email 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
Email k-kobayashi@shin-tokyohospital.or.jp

Sponsor
Institute New Tokyo Hospital
Institute
Department

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
Email 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
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
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
2020 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047372

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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