Evaluating performance of facemasks in reducing ambient particulate matter (PM10، PM2.5، PM1) exposure and theirs wearing on acute cardiovascular effects: A Randomized crossover trial
Evaluating effectiveness of using facemasks on acute cardiovascular effects
Design
We will conduct a randomized crossover trial among 30 healthy college students at Tehran university of medical sciences from 24 January 2019 to 7 February 2019. These students live in dormitory that are randomized into 2 groups (15 subjects for each group) and alternate the use of/or without wearing particulate-filtering facemask for 48h with a 2-week washout interval.
Settings and conduct
Please see above.
Participants/Inclusion and exclusion criteria
college students with no history of tobacco smoking (never smokers) or alcohol addiction, no clinically diagnosed chronic cardiopulmonary diseases and no recent infections.
Intervention groups
Wearing particulate-filtering respirators
Without particulate-filtering respirators
Main outcome variables
Heart Rate Variability
Blood pressure
Biomarkers of hs-cTnT and NT-proBNP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181214041961N1
Registration date:2019-01-14, 1397/10/24
Registration timing:prospective
Last update:2019-01-14, 1397/10/24
Update count:0
Registration date
2019-01-14, 1397/10/24
Registrant information
Name
Kazem Naddafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 4914
Email address
knadafi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-24, 1397/11/04
Expected recruitment end date
2019-02-06, 1397/11/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating performance of facemasks in reducing ambient particulate matter (PM10، PM2.5، PM1) exposure and theirs wearing on acute cardiovascular effects: A Randomized crossover trial
Public title
Cardiovascular Benefits of Wearing Particulate-Filtering facemasks
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
no history of tobacco smoking (never smokers)
no alcohol addiction
no clinically diagnosed chronic cardiopulmonary diseases
no recent infections
Exclusion criteria:
Age
From 20 years old to 30 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Qods st, Blvd Keshavarz
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-11-13, 1397/08/22
Ethics committee reference number
IR.TUMS.SPH.REC.1397.163
Health conditions studied
1
Description of health condition studied
acute cardiovascular effects
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Heart rate variability
Timepoint
Heart rate variability will be continuously monitored during the 2nd 24 hr in each intervention.
Method of measurement
A 12-lead continuous electrographic Holter monitor will be used.
2
Description
Blood pressure
Timepoint
Blood pressure will be continuously monitored during the 2nd 24 hr in each intervention.
Method of measurement
A portable and automated ambulatory BP monitoring and recording instrument will be used.
3
Description
Biomarkers of NT-proBNP and hs-cTnT
Timepoint
A venous blood sample will be collected at the end of ecah intervention in order to examine the level of each above-mentioned biomarkers.
Method of measurement
They will be measured using enzyme-linked immunosorbent assays.
Secondary outcomes
empty
Intervention groups
1
Description
Wearing particulate-filtering facemask
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Masih Tajdini
Street address
North Kargar-Ave
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Email
masihtajdini@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran National Science Foundation
Full name of responsible person
-
Street address
33, 5th St., North Kargar St.
City
Tehran
Province
Tehran
Postal code
1439634665
Phone
+98 21 8216 1157
Email
environment@insf.org
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran National Science Foundation
Proportion provided by this source
45
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
2
Sponsor
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Saeed Sadeghian
Street address
North Kargar-Ave , Tehran-Iran
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
+98 21 8802 9731
Email
sadeghian@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Heart Center
Proportion provided by this source
55
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masih Tajdini
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
North Kargar-Ave
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 6643 7147
Email
Drmasih84@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Hassanvand
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Environmental Health
Street address
Center for Air Pollution Research, 8th Floor, No. 1547, North Kargar Avenue, Tehran I.R. Iran
City
Tehran
Province
Tehran
Postal code
1417993362
Phone
+98 21 8897 8395
Fax
+98 21 8897 8398
Email
Hassanvand@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sasan Faridi
Position
Ph.D candidate
Latest degree
Master
Other areas of specialty/work
Environmental Health
Street address
Center for Air Pollution Research, 8th Floor, No. 1547, North Kargar Avenue, Tehran I.R. Iran
City
Tehran
Province
Tehran
Postal code
1417993362
Phone
+98 21 8897 8395
Fax
+98 21 8897 8397
Email
Sasanfaridi67@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
These information will be published at the report and article of the current study.
When the data will become available and for how long
After the end of study
To whom data/document is available
Researchers
Policy-makers
Under which criteria data/document could be used
with referencing
From where data/document is obtainable
Sasan Faridi
Mohammad Sadegh Hassanvand
What processes are involved for a request to access data/document