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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026724
Receipt No. R000030678
Scientific Title Study on the relationship between optical coherence tomography findings and clinical prognosis in patients after coronary artery stent implantation
Date of disclosure of the study information 2017/03/27
Last modified on 2017/03/27

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Basic information
Public title Study on the relationship between optical coherence tomography findings and clinical prognosis in patients after coronary artery stent implantation
Acronym Study on the relationship between optical coherence tomography findings and clinical prognosis in patients after coronary artery stent implantation
Scientific Title Study on the relationship between optical coherence tomography findings and clinical prognosis in patients after coronary artery stent implantation
Scientific Title:Acronym Study on the relationship between optical coherence tomography findings and clinical prognosis in patients after coronary artery stent implantation
Region
Japan

Condition
Condition Among the patients who had implanted the coronary artery stent, patients who underwent follow up OCT
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aim to clarify the risk factors on clinical prognosis in OCT findings of patients with stent implantation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Death, myocardial infarction, TLR,TVR
Key secondary outcomes

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
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients with stent implantation who underwent OCT follow-up during the period from January 1, 2007 to March 31, 2016.
Key exclusion criteria Patients meeting one of the following conditions will be excluded:
1) renal dysfunction (<Cre 2.0mg/dL)
2) severe heart failure (NYHA/New York Heart Association stage III or severer)
3) malignancies or other diseases with poor prognosis
4) pregnant, lactating, and possibly pregnant women and those planning to become pregnant
5) Patients who have offered to stop using data for this research
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiro Shinke
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL 078-382-5111
Email shinke@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Kuroda
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL 078-382-5111
Homepage URL
Email k722black@yahoo.co.jp

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization Kobe University
Organization
Division
Category of Funding Organization Other
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 03 Month 27 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 No longer recruiting
Date of protocol fixation
2016 Year 07 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Perform qualitative and quantitative analysis of OCT findings on each stent. There is no limit on the duration of the OCT follow up. Evaluation of clinical prognosis is the longest 5 years from the day of OCT procedure.

Management information
Registered date
2017 Year 03 Month 27 Day
Last modified on
2017 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030678

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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