UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045384 |
|---|---|
| Receipt number | 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 09:20:22 |
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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
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
han_taman@yahoo.com
Sponsor or person
Institute
MANSOURA UNIVERSITY
Institute
Department
Personal name
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
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
Value
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 | |
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| Registered date | File name |
| Research case data | |
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