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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027419
Receipt No. R000031418
Scientific Title SAKURA-PCI, intravascular imaging registry(multi-center study)
Date of disclosure of the study information 2017/06/01
Last modified on 2018/05/22

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Basic information
Public title SAKURA-PCI, intravascular imaging registry(multi-center study)
Acronym SAKURA-PCI, imaging registry
Scientific Title SAKURA-PCI, intravascular imaging registry(multi-center study)
Scientific Title:Acronym SAKURA-PCI, imaging registry
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to registry PCI and intravascular imaging and analyze the prognosis for one year after registration.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes I year MACE and composite end point of all cause of death, non-fatal MI, stroke, TLR and bleeding event)
Key secondary outcomes Observation of progression and regression of coronary atherosclerotic lesion

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

Not applicable
Gender Male and Female
Key inclusion criteria The study will enroll patients who are sheduled for PCI and/or observational study of coronary artery using intravascular imaging modalities in patients coronary artery
disease.

Patients must be over 20 years old.

Patients who we can follow-up for one year in principle.
Key exclusion criteria Patients from whom no written consent is obtained.

Other patients considered ineligeble for this clinical study by investigator.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Hirayama
Organization Nihon University school of Medicine
Division name Division of Cardiology, Departement of Medicine
Zip code
Address 30-1 Oyaguchi kamichou, Itabashi-ku, Tokyo, Japan 173-8610
TEL 03-3972-8111
Email hirayama.atsushi@nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadateru Takayama
Organization Nihon University
Division name Division of Cardiology, Department of Medicine
Zip code
Address 30-1 Oyaguchi kamichou, Itabashi-ku, Tokyo, Japan 173-8610
TEL 03-3972-8111
Homepage URL
Email takayama.tadateru@nihon-u.ac.jp

Sponsor
Institute Nihon University
Institute
Department

Funding Source
Organization Daichi-sankyo
Organization
Division
Category of Funding Organization Profit organization
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
2017 Year 06 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
2016 Year 10 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 18 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Clinical follow is one year.
Imaging is performed at the first and post-PCI follow-up (analysis at 0.5 mm intervals)

Management information
Registered date
2017 Year 05 Month 20 Day
Last modified on
2018 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031418

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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