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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033927
Receipt No. R000038456
Scientific Title Prospective observational study to evaluate using OCT in stent neoatherosclerosis for patients after Everolimus-eluting stent (EES) implantation in the late phase.
Date of disclosure of the study information 2018/11/01
Last modified on 2018/08/28

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Basic information
Public title Prospective observational study to evaluate using OCT in stent neoatherosclerosis for patients after Everolimus-eluting stent (EES) implantation in the late phase.
Acronym NA-EES registry
Scientific Title Prospective observational study to evaluate using OCT in stent neoatherosclerosis for patients after Everolimus-eluting stent (EES) implantation in the late phase.
Scientific Title:Acronym NA-EES registry
Region
Japan

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

Objectives
Narrative objectives1 This study is prospective observational study to evaluate using OCT in stent neoatherosclerosis for patients after Everolimus-eluting stent (EES) implantation in the late phase. It is aim to evaluate the presence of neoatherosclerosis and to examine related factors.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes It is aim to evaluate the presence of neoatherosclerosis using OCT in late phase of Everolimus eluting stent implantation, and to examine related factors.
Key secondary outcomes 1)Various data obtained by OCT (Minimum lumen area, Minimum stent area, Average neointimal thickness, Lipid arc, Lipid length, Lipid index, Neoatherosclerosis, Thin cap fibroatheroma(TCFA), Macrophage grade, Peri-strut low intensity areas(PLIA), Neointimal rapture, Thrombi, Neointimal calcification
2)laboratory data (Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride, small LDL-C, ApoA-1, ApoB, ApoB/ApoA-1 ratio, Lp(a), TNF-a, IL-6, MMP-9, Fasting plasma glucose, HbA1c
3)Safety endpoint; Major cardiovascular events (MACE), All cause death, Non-cardiac death

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
90 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients aged 20 years or older at the time of PCI
2)Patients who underwent PCI with acute coronary syndrome (STEMI, NSTEMI, uAP) or sAP and had Everolimus eluting stent implantation.
3)Patients who can obtain analyzable images at the time of OCT and who undergo OCT evaluation 9 months after PCI
4)Patients who were over 3 years after PCI
5)Patients who written consent
Key exclusion criteria 1)Patients who can not written consent
2)Patient judged inappropriate by the attending physician
Target sample size 200

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

Public contact
Name of contact person
1st name
Middle name
Last name Kosuke Tanimura
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine
Zip code
Address Chuo-ku Kusunomachi 7-5-2, Kobe City, Hyogo
TEL 078-382-5846
Homepage URL
Email k.tanimura1006@gmail.com

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

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 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
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
2018 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2018 Year 08 Month 28 Day
Last modified on
2018 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038456

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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