UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043308 |
|---|---|
| Receipt number | R000049446 |
| Scientific Title | An Outlook of Coronary Stent Infection |
| Date of disclosure of the study information | 2021/02/12 |
| Last modified on | 2022/01/07 08:18:20 |
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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
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
eka.prasetya.budi-2017@fk.unair.ac.id
Sponsor or person
Institute
Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
https://journals.lww.com/coronary-artery/Abstract/9000/Coronary_stent_infection__a_systematic_review
Number of participants that the trial has enrolled
34
Results
Thirty-two studies composed of 34 CSI patients were included in final qualitative analysis. CSI dominantly affected male and had wide range of age. Cultures and coronary angiography were the most common diagnostic method in CSI. Usual causative bacteria were Staphylococcus aureus and Pseudomonas aeroginosa. More than 90% of the cases mentioned various antibiotics and more than 75% mentioned surgery. Current systematic review demonstrated mortality rate among CSI patients was 26.47%.
Results date posted
| 2021 | Year | 02 | Month | 27 | Day |
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
Completed
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
| 2021 | Year | 02 | Month | 20 | Day |
Date trial data considered complete
| 2021 | Year | 02 | Month | 25 | Day |
Date analysis concluded
| 2021 | Year | 02 | Month | 27 | Day |
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
| 2022 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049446
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| Registered date | File name |
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