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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043308
Receipt No. R000049446
Scientific Title An Outlook of Coronary Stent Infection
Date of disclosure of the study information 2021/02/12
Last modified on 2021/02/12

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Basic information
Public title An Outlook of Coronary Stent Infection
Acronym An Outlook of Coronary Stent Infection
Scientific Title An Outlook of Coronary Stent Infection
Scientific Title:Acronym An Outlook of Coronary Stent Infection
Region
Asia(except Japan)

Condition
Condition Coronary stent infection
Classification by specialty
Medicine in general Cardiology Infectious disease
Cardiovascular surgery Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Previous study had been reviewed 23 cases and demonstrated the mortality rate of CSI was 39%.5 Moreover, CSI yields various clinical presentations and often confusing. Therefore, this study aims to systematically review clinical presentation, causative pathogens, diagnosis, and treatment of reported CSI.
Basic objectives2 Others
Basic objectives -Others this study aims to systematically review clinical presentation, causative pathogens, diagnosis, and treatment of reported CSI.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes clinical presentation, causative pathogens, diagnosis, and treatment of CSI.
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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
18 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Inclusion criteria is case report or case series with stent infection in coronary artery
Key exclusion criteria exclusion criteria were (1) reviews or commentary, (2) not published in English, and (3) history of hemodialysis or any surgery.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Eka
Middle name Prasetya Budi
Last name Mulia
Organization Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Division name Department of Cardiology and Vascular Medicine
Zip code 60131
Address Jl. Mayjen Prof. Dr. Moestopo 47
TEL 62-8562765365
Email eka.prasetya.budi-2017@fk.unair.ac.id

Public contact
Name of contact person
1st name Eka
Middle name Prasetya Budi
Last name Mulia
Organization Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Division name Department of Cardiology and Vascular Medicine
Zip code 60131
Address Jl. Mayjen Prof. Dr. Moestopo 47
TEL 628562765365
Homepage URL https://www.researchgate.net/profile/Eka_Mulia
Email eka.prasetya.budi-2017@fk.unair.ac.id

Sponsor
Institute Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Institute
Department

Funding Source
Organization None
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 Komite Etik Penelitian Kesehatan RSUD Dr Soetomo, Surabaya, Indonesia
Address Jalan Mayjen. Prof. Dr. Moestopo No. 6-8, Surabaya, Jawa Timur 60286
Tel 62315501011
Email kontak@rsudrsoetomo.jatimprov.go.id

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
2021 Year 02 Month 12 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 Open public recruiting
Date of protocol fixation
2021 Year 01 Month 20 Day
Date of IRB
2021 Year 01 Month 27 Day
Anticipated trial start date
2021 Year 01 Month 31 Day
Last follow-up date
2021 Year 02 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A literature search was conducted on 3 online databases (PubMed, ScienceDirect, and ProQuest). Collected data will be presented descriptively based on baseline characteristics, clinical presentation, diagnostic methods, stents and vessel pathology, causative pathogens, managements and outcome.

Management information
Registered date
2021 Year 02 Month 12 Day
Last modified on
2021 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049446

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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