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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000045384
Receipt No. R000051825
Scientific Title Heart rate variability as an indicator of COVID-19 induced myocardial injury.
Date of disclosure of the study information 2022/01/10
Last modified on 2021/09/05

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Basic information
Public title Heart rate variability as an indicator of COVID-19 induced myocardial injury.
Acronym Heart rate variability and myocardial injury.
Scientific Title Heart rate variability as an indicator of COVID-19 induced myocardial injury.
Scientific Title:Acronym Heart rate variability indicated COVID associated myocardial injury myocardial injury.
Region
Africa

Condition
Condition Myocardial injury that results as a complication of COVID 19 infection
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to verify the relationship between COVID-19 infection and changes in HRV
Basic objectives2 Others
Basic objectives -Others was to evaluate the possibility to use HRV as a diagnostic tool of COVID-19 induced myocardial injury.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes confirmation the incidence of heart rate variability in COVID 19 infection
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
18 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria a) age between 18-65 years; b)confirmed COVID 19 infection; c)myocardial injury diagnosed by three different methods (elevated cardiac enzymes, ECG changes and abnormal ECHO changes); d) onset of myocardial affection within 1 week of admission.
Key exclusion criteria a) patients with known cardiac disease (IHD, CHF, myocarditis or arrythmias) within last six months prior COVID 19 infection; b) patients with metabolic, autoimmune diseases and diabetes mellites; c) patients with poor physical compliance; d) patients with incomplete clinical data.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name HANI
Middle name
Last name TAMAN
Organization MANSOURA FACULTY OF MEDICINE, MANSOURA UNIVERSITY, MANSOURA, EGYPT
Division name ANAETHESIA DEPARTMENT
Zip code 53333
Address 12
TEL 01008288242
Email hani_taman@yahoo.com

Public contact
Name of contact person
1st name HANI
Middle name
Last name TAMAN
Organization MANSOURA FACULTY OF MEDICINE, MANSOURA UNIVERSITY, MANSOURA, EGYPT
Division name ANAETHESIA DEPARTMENT
Zip code 53333
Address 10, ELHAWARY STREET, DIKERNESS
TEL 01008288242
Homepage URL
Email han_taman@yahoo.com

Sponsor
Institute MANSOURA UNIVERSITY
Institute
Department

Funding Source
Organization MANSOURA FACULTY OF MEDICINE, MANSOURA UNIVERSITY, MANSOURA, EGYPT
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Mansoura faculty of Medicine IRB
Address 12 ELGOMHORIA ATREET, MANSOURA, EGYPT
Tel 00202202746
Email IRB.MFM@hotmail.com

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
2022 Year 01 Month 10 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 40
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 Completed
Date of protocol fixation
2020 Year 04 Month 01 Day
Date of IRB
2021 Year 08 Month 01 Day
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2021 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1- Incidence of HRV in COVID patients.
2- Comparing HRV to other indicators of myocardial injury
HRV, troponin, EF, ST elevation, CKMB and CK

Management information
Registered date
2021 Year 09 Month 05 Day
Last modified on
2021 Year 09 Month 05 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051825

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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