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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042006
Receipt No. R000047941
Scientific Title Plaque progression from normal vessel wall to fibroatheroma: lessons from over 5-year follow-up optical coherence tomography study
Date of disclosure of the study information 2020/11/01
Last modified on 2020/10/05

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Basic information
Public title Plaque progression from normal vessel wall to fibroatheroma: lessons from over 5-year follow-up optical coherence tomography study
Acronym Plaque progression from normal vessel wall to fibroatheroma
Scientific Title Plaque progression from normal vessel wall to fibroatheroma: lessons from over 5-year follow-up optical coherence tomography study
Scientific Title:Acronym Plaque progression from normal vessel wall to fibroatheroma
Region
Japan

Condition
Condition coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to investigate the incidence and related factors associated with atherosclerotic progression from normal vessel wall (NVW) to fibroatheroma
Basic objectives2 Others
Basic objectives -Others The objective of the present study is to investigate the incidence and related factors associated with atherosclerotic progression from NVW to fibroatheroma using long-term serial OCT follow-up data over 5 years.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Presence of atheroma progression between Baseline and Follow-up
Key secondary outcomes Baseline OCT findings and atheroma progression
Serial changes of the intimal thickness during the follow-up period

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who underwent OCT imaging for native coronary artery were screened, we enrolled the patients who met the following inclusion and exclusion criteria into the present study. The inclusion criteria included patients 1) who underwent serial OCT imaging for native coronary artery over 5 years; 2) who underwent OCT for early atherosclerotic lesions located >5mm away from the stent edges, defined as diameter stenosis <30% on coronary angiography
Key exclusion criteria The exclusion criteria included patients 1) who had undergone bypass graft surgery; 2) with chronic total occlusion lesions within the target vessel; 3) with poor OCT images; 4) who had undergone coronary revascularization within the same vessel during the follow-up period.
Target sample size 49

Research contact person
Name of lead principal investigator
1st name Hiromasa
Middle name
Last name Otake
Organization Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine
Zip code 6500017
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL 078-382-5846
Email hotake@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Ryo
Middle name
Last name Takeshige
Organization Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name Division of cardiology
Zip code 6500017
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL 078-382-5846
Homepage URL
Email takeshige.kobe@gmail.com

Sponsor
Institute Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
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 Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Tel 078-382-5846
Email takeshige.kobe@gmail.com

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 11 Month 01 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 49
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 Completed
Date of protocol fixation
2020 Year 08 Month 01 Day
Date of IRB
2020 Year 10 Month 12 Day
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Baseline OCT images were evaluated every 1mm slice. Then, matched follow-up OCT images were selected. The cross-sections were diagnosed as Progression when NVW in the cross-section reduced by >30 degrees from baseline OCT to >5-year follow-up OCT. We investigated the incidence and related factors associated with atherosclerotic progression from NVW to fibroatheroma using long-term serial OCT follow-up data over 5 years.

Management information
Registered date
2020 Year 10 Month 05 Day
Last modified on
2020 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047941

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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