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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040642
Receipt No. 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 2020/06/03

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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
Email 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
Email anhiro@aichi-med-u.ac.jp

Sponsor
Institute Aichi Medical University
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 Ethics Committee of Aichi Medical University
Address 1-1 Yazakokarimata Nagakute, Aichi
Tel 0561-62-3311
Email anhiro@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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 01 Day
Date of IRB
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
2020 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046387

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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