UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040642 |
|---|---|
| Receipt number | R000046387 |
| Scientific Title | Assessment of neointimal coverage using two different imaging modalities at 2-week and 6-month after ultrathin vs thin strut drug-eluting stent implantation in coronary artery disease patients with ST elevation myocardial infarction -high-resolution angioscopy and OCT study- |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2022/12/05 09:16:38 |
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Basic information
Public title
Assessment of neointimal coverage using two different imaging modalities at 2-week and 6-month after ultrathin vs thin strut drug-eluting stent implantation in coronary artery disease patients with ST elevation myocardial infarction -high-resolution angioscopy and OCT study-
Acronym
NAGAKUTE-CASTLE study
Scientific Title
Assessment of neointimal coverage using two different imaging modalities at 2-week and 6-month after ultrathin vs thin strut drug-eluting stent implantation in coronary artery disease patients with ST elevation myocardial infarction -high-resolution angioscopy and OCT study-
Scientific Title:Acronym
NAGAKUTE-CASTLE study
Region
| Japan |
Condition
Condition
Acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the neointimal coverage at 14 days after stent placement (Orsiro and Xience) using the imaging devices of OCT/OFDI and angioscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neointimal coverage rate at 2-week after stent implantation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Orsiro stent
Interventions/Control_2
Xience stent
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with st-elevation myocardial infarction less than 12 hours after onset (Orsiro group: 55 cases, XIENCE group: 55 cases)
(2) Patients who can be followed up in all clinical situations
(3) Patients who can be observed by angiography, OCT/OFDI and angioscopy 2 weeks after PCI
(4) Patients who can be observed by angiography, OCT/OFDI 6 months after surgery
(5) Patients with medical indication of PCI
Key exclusion criteria
(1) Patients who cannot obtain written consent after oral consent by the patient or his/her legal representative
(2) Patients with cardiogenic shock
(3) Hemodialysis patients
(4) Left main lesion / Bifurcation lesion requiring two stents / In-stent restenosis lesion
(5) The target lesion is in the arterial bypass graft or saphenous vein bypass graft, or distal to the graft anastomosis site
(6) Patients who are contraindicated for antiplatelet therapy or anticoagulant therapy
(7) Patients who have difficulty in proper drug therapy
(8) Patients who have a contraindication to contrast agents or have allergies to contrast agents
(9) Patients scheduled for cardiac surgery within 6 months
(10) Patients who have participated in another study and have not completed the observation period in that study
(11) Patients who are judged to be unfavorable for participation in this study by the investigator and investigator
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Amano |
Organization
Aichi Medical University
Division name
Cardiology
Zip code
480-1195
Address
1-1 Yazakokarimata Nagakute, Aichi
TEL
0561-62-3311
amanotaha@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hirohiko |
| Middle name | |
| Last name | Ando |
Organization
Aichi Medical University
Division name
Cardiology
Zip code
480-1195
Address
1-1 Yazakokarimata Nagakute, Aichi
TEL
0561-62-3311
Homepage URL
anhiro@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
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
Ethics Committee of Aichi Medical University
Address
1-1 Yazakokarimata Nagakute, Aichi
Tel
0561-62-3311
amu_ethics@aichi-med-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
愛知医科大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 03 | Day |
Last modified on
| 2022 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046387
