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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042424
Receipt No. R000048431
Scientific Title Prevalence of Right Ventricular Dysfunction and Its Association with COVID-19 Clinical Outcome: A Meta-Analysis
Date of disclosure of the study information 2020/11/11
Last modified on 2020/11/11

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Basic information
Public title Prevalence of Right Ventricular Dysfunction and Its Association with COVID-19 Clinical Outcome: A Meta-Analysis
Acronym Prevalence of Right Ventricular Dysfunction and Its Association with COVID-19 Clinical Outcome: A Meta-Analysis
Scientific Title Prevalence of Right Ventricular Dysfunction and Its Association with COVID-19 Clinical Outcome: A Meta-Analysis
Scientific Title:Acronym Prevalence of Right Ventricular Dysfunction and Its Association with COVID-19 Clinical Outcome: A Meta-Analysis
Region
Asia(except Japan)

Condition
Condition COVID-19
Classification by specialty
Medicine in general Cardiology Pneumology
Infectious disease Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyze the prevalence of right ventricular dysfunction AND its association with COVID-19 clinical outcome.
Basic objectives2 Others
Basic objectives -Others To analyze the prevalence and association of pulmonary hypertension with COVID-19 outcome
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Composite poor outcome of severity. mortality, need for ICU and mechanical ventilation
Key secondary outcomes each percentage of primary outcome: severity. mortality, need for ICU and mechanical ventilation

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 all observational studies or trials that involving adult patients with COVID-19 that had any data of right ventricular dysfunction and pulmonary arterial hypertension for comparison poor vs good outcome
Key exclusion criteria missing required data, no data on RVD/ PAH, no outcome of interest, other than english language
Target sample size 1000

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 Government offices of other countries
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 0315501011
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
2020 Year 11 Month 11 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 11 Month 11 Day
Date of IRB
Anticipated trial start date
2020 Year 11 Month 11 Day
Last follow-up date
2020 Year 11 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A systematic search of all observational studies or trials that involving adult patients with COVID-19 that had any data of RVD and PAH for comparison of poor vs good outcome was carried out using the PubMed, Science Direct, Scopus, ProQuest, and MedRxiv databases.

Management information
Registered date
2020 Year 11 Month 11 Day
Last modified on
2020 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048431

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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