UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033927 |
|---|---|
| Receipt number | 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 | 2020/01/24 15:47:23 |
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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 | Hiromasa |
| Middle name | |
| Last name | Otake |
Organization
Kobe University Hospital
Division name
Division of Cardiovascular Medicine
Zip code
6500017
Address
Chuo-ku Kusunomachi 7-5-2, Kobe City, Hyogo
TEL
078-382-5846
hotake@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Tanimura |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
650-0017
Address
Chuo-ku Kusunomachi 7-5-2, Kobe City, Hyogo
TEL
078-382-5846
Homepage URL
k.tanimura1006@gmail.com
Sponsor or person
Institute
Kobe University Graduate School of Medicine, Division of Cardiovascular Medicine
Institute
Department
Personal name
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
Kobe University Hospital Clinical Translational Research Center
Address
Chuo-ku Kusunomachi 7-5-2, Kobe City, Hyogo
Tel
078-382-6669
chiken@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
| 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2021 | 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
| 2018 | Year | 08 | Month | 28 | Day |
Last modified on
| 2020 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038456
