UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051825