The purpose of this study is to comparing flow mediated dilation (FMD) through two methods of compression of the brachial and ulnar artery.
Design
The clinical trial was conducted on two randomized cross-over and double-blind groups on 30 volunteers .
Settings and conduct
30 volunteers referred to the catheterization department of Imam Khomeini Hospital were studied. After 15 minutes of rest, the baseline diameter of the radial artery was measured. In the first group the ulnar artery was compressed for 5 minutes, and the two-dimensional images of radial artery were recorded after the compression was released, every 30 seconds to 2 minutes. In the second group, a cuff was fixed in the upper arm area and 30 mmHg Above systolic pressure was inflated for 5 minutes and then two-dimensional images were recorded at the mentioned time intervals. Then, in each group, another maneuver was performed in the evening of the same day .
Participants/Inclusion and exclusion criteria
Participants with history of angiography through the radial artery, and a history of taking vasoactive drugs or congenital heart disease will be excluded from the study.
Intervention groups
First group: ulnar compression will be done at 8-10 in the morning and Upper arm compression will be done at 4-6 in the evening. The second group: Upper arm compression will be done at 8-10 in the morning and ulnar compression will be done at 4-6 in the evening.
Main outcome variables
The effect of the studied maneuvers on the diameter and area of the radial artery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230209057372N1
Registration date:2023-10-03, 1402/07/11
Registration timing:registered_while_recruiting
Last update:2023-10-03, 1402/07/11
Update count:0
Registration date
2023-10-03, 1402/07/11
Registrant information
Name
fateme bahrami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2648
Email address
fatemehbahrami288@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-28, 1402/07/06
Expected recruitment end date
2023-10-28, 1402/08/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing radial artery flow-mediated dilation in transient ulnar and brachial artery compression
Public title
Comparing radial artery flow-mediated dilation in transient ulnar and brachial artery compression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants over the age of18 years old should not have a history of angiography through the radial artery.
Participants over the age of18 years old should not have a history of use of vasoactive drugs include 1)Catecholamines: adrenaline ,noradrenaline ,dopamine ,dobutamine ,... 2)vasodilators :nitrates ,... 3)Vasopressors : phenylephrine ,vasopressin,...4)Phosphodiesterase inhibitors 5)Calcium Sensitizers and digoxin ,calcium.
Participants over the age of18 years old should not have a history of congenital heart disease.
Exclusion criteria:
The participant's request to exit from the study before the completion of study.
The need to take vasoactive drugs during the study according to therapeutic indications
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blocks were used for randomization and the participants were divided into 6 blocks of 5 participants.
3 blocks were assigned to group 1; another 3 blocks assigned to group 2.
Blinding (investigator's opinion)
Double blinded
Blinding description
Before starting the study, the participant does not know which group he is in
The first group measured the diameter of the radial artery by closing the cuff on the brachial area in the morning and pressing on the ulnar area in the afternoon.
The second group measured the diameter of the radial artery by pressing on the ulnar area in the morning and closing the cuff in the brachial area in the afternoon.
The radiologist who measures the diameter and area of the radial artery before and after the maneuver does not know the type of maneuver and the time of the study.
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
Keshavarz Boulevard, corner of Qods St., Central Organization of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-01-22, 1401/11/02
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.310
Health conditions studied
1
Description of health condition studied
coronary angiography by radial access
ICD-10 code
_
ICD-10 code description
_
Primary outcomes
1
Description
Diameter of radial artery
Timepoint
Before starting the maneuver and after finishing the maneuver every 30 seconds to 2 minutes
Method of measurement
Two-dimensional images of vivid IQE ultrasound machine
2
Description
Area of radial artery
Timepoint
Before starting the maneuver and after finishing the maneuver every 30 seconds to 2 minutes
Method of measurement
Two-dimensional images of vivid IQE ultrasound machine
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ulnar compression will be done for 5 minutes at 8-10 in the morning, and brachial compression will be done at 4-6 in the evening for 5 minutes.
Category
Treatment - Devices
2
Description
Intervention group: at 8-10 in the morning brachial compression will be performed for 5 minutes, and at 4-6 in the evening, ulnar compression will be performed for 5 minutes.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
catheterism unit of tehran emam khomeini hospital
Full name of responsible person
Fateme Bahrami
Street address
Keshavarz Boulevard
City
tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2648
Email
fatemehbahrami288@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotoohi
Street address
Keshavarz Blvd., corner of Quds St., Central Organization of the University, 6th floor of Research and Technology Vice-Chancellor
City
Tehran
Province
Tehran
Postal code
8163368521
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice President of Research and Technology, Tehran University of Medical Sciences
Proportion provided by this source
100
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
Fateme Bahrami
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Keshavarz Blvd
City
tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2648
Email
fatemehbahrami288@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fateme Bahrami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Imam Khomaini hospital, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2648
Fax
Email
fatemehbahrami288@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fateme Bahrami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Imam Khomaini hospital, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2648
Fax
Email
fatemehbahrami288@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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