A clinical trial to compare the fluoroscopy time of coronary catheterization via right radial artery by left emplacement catheter with left Judkins catheter in pseudo-arteria lusoria patient
A clinical trial to compare the fluoroscopy time of coronary catheterization via right radial artery by left emplacement catheter with left Judkins catheter in pseudo-arteria lusoria patient
Design
Forty patients who were candidates for angiography, clinical trial with control group, community based pragmatic, parallel group, single-blind, randomized using table of random numbers
Settings and conduct
Patients candidate for angiography at the Department of cardiology, Ghaem Hospital, Mashhad, Iran, were chosen. In this single-blind study, the participants were unaware of the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age higher than 20 years; patients candidate for angiography by Cardiologist; having hemodynamic stability; negative Allen's test.
Exclusion criteria: History of coronary artery bypass graft (CABG); having percutaneous coronary intervention (PCI); upper extremity deformities; history of peripheral artery disease (PAD) of the upper extremities.
Intervention groups
Intervention group I: A 0.035-inch wire is entered into the right subclavian artery and in case of observing an angle of less than 70 degrees between the brachycephalic and the aortic arch and the diagnosis of pseudo-arteria lusoria, the left catheter emplacement will be used. Intervention group II: A 0.035-inch wire is entered into the right subclavian artery and in case of observing an angle of less than 70 degrees between the brachycephalic and the aortic arch and the diagnosis of pseudo-arteria lusoria, the left Judkins catheter will be used.
Main outcome variables
Evaluation and comparison of time of fluoroscopic since catheterization entry into radial artery until laryngeal mask airway (LMA) engage between two intervention groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180617040123N1
Registration date:2018-09-18, 1397/06/27
Registration timing:registered_while_recruiting
Last update:2018-09-18, 1397/06/27
Update count:0
Registration date
2018-09-18, 1397/06/27
Registrant information
Name
Laya Valaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3858 3853
Email address
valaeil941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the fluoroscopy time of coronary catheterization via right radial artery by left emplacement catheter with left Judkins catheter in pseudo-arteria lusoria patient
Public title
The fluoroscopy time in pseudo-arteria lusoria patient
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Age higher than 20 years
Patients candidate for angiography by Cardiologist
Having hemodynamic stability
Negative Allen's test
Exclusion criteria:
History of coronary artery bypass graft (CABG)
Having percutaneous coronary intervention (PCI)
Upper extremities deformities
History of peripheral artery disease (PAD) of the upper extremities
Age
From 20 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Forty patients who were candidates for angiography at the Department of Cardiology in Ghaem Hospital, Mashhad, Iran, were randomly allocated using table of random numbers based on computer programs. To this end, a code is allocated to each of the participants to be assigned into one of the two groups of intervention or control.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients candidate for angiography at the Department of cardiology, Ghaem Hospital, Mashhad, Iran, were chosen. In this single-blind study, the participants were unaware of the type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2017-11-08, 1396/08/17
Ethics committee reference number
Ir.mums.fm.rec.1396.490
Health conditions studied
1
Description of health condition studied
pseudo-arteria lusoria patient
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Time of fluoroscopic
Timepoint
Since catheterization entry into radial artery until laryngeal mask airway (LMA) engage
Method of measurement
Timer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A 0.035-inch wire is entered into the right subclavian artery and in case of observing an angle of less than 70 degrees between the brachycephalic and the aortic arch and the diagnosis of pseudo-arteria lusoria, the left catheter emplacement will be used.
Category
Diagnosis
2
Description
Intervention group: A 0.035-inch wire is entered into the right subclavian artery and in case of observing an angle of less than 70 degrees between the brachycephalic and the aortic arch and the diagnosis of pseudo-arteria lusoria, the left Judkins catheter will be used.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Laya Valae
Street address
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3858 3853
Email
ValaeiL941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91375-345
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Laya Valaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3858 3853
Email
ValaeiL941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Laya Valaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3858 3853
Email
ValaeiL941@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Laya Valaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3858 3853
Email
ValaeiL941@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
The total data to be included are the primary and secondary effects to be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working in science center and university.
Under which criteria data/document could be used
Our data will be available for scholars working in science center and university.
From where data/document is obtainable
Laya Valaei provides the analysis code to the applicants via email: bahadoripb901@mums.ac.ir
What processes are involved for a request to access data/document
Data collection was done for 10 months, data were collected one month, statistical analysis of one month, information dissemination as a article six months.