Protocol summary

Study aim
Comparison of the success and patient satisfaction in coronary catheterization of Distal Radial Approach Using a "Snuff Box" and the Proximal Radial Approach
Design
randomized clinical trial ,sample number 70.divided in 2 parallel group of 35 patient ,
Settings and conduct
this trial will be done at imam reza hospital. for patient who need angiography or angioplasty due to medical assessment and after acceptance by patient
Participants/Inclusion and exclusion criteria
entry criteria :patient who need an angiography or angioplasty exit criteria: structural anomalies at this site ,refused by patient
Intervention groups
distal snuff box coronary angiography or angioplasty
Main outcome variables
Comparison of the success and patient satisfaction in coronary catheterization of Distal Radial Approach Using a "Snuff Box" and the Proximal Radial Approac

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221221056888N1
Registration date: 2023-11-18, 1402/08/27
Registration timing: registered_while_recruiting

Last update: 2023-11-18, 1402/08/27
Update count: 0
Registration date
2023-11-18, 1402/08/27
Registrant information
Name
Moustafa Nasser eddine
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 901 320 2144
Email address
naseroddinm991@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-11, 1402/08/20
Expected recruitment end date
2025-11-11, 1404/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the success and patient satisfaction in coronary catheterization of Distal Radial Approach Using a "Snuff Box" and the Proximal Radial Approach
Public title
Comparison of the success and patient satisfaction in coronary catheterization of Distal Radial Approach Using a "Snuff Box" and the Proximal Radial Approach
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients who need angiography or angioplasty
Exclusion criteria:
structure anomalies at distal or proximal radius patient who refuse radial angiography
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
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
No.12,dastgheyb 9
City
Mashhad
Province
Razavi Khorasan
Postal code
918 789 3335
Approval date
2022-11-14, 1401/08/23
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.473

Health conditions studied

1

Description of health condition studied
Comparison of the success and patient satisfaction in coronary catheterization of Distal Radial Approach Using a "Snuff Box" and the Proximal Radial Approach
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Comparison of the success and patient satisfaction in coronary catheterization of Distal Radial Approach Using a "Snuff Box" and the Proximal Radial Approach
Timepoint
12 months
Method of measurement
angiography distal or proximal

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients underwent angiography or angioplasty by radial distal method 'Snuff Box'
Category
Treatment - Surgery

2

Description
Control group: Patients underwent angiography or angioplasty by radial proximal method.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
imam reza hospital
Full name of responsible person
mahmoud mohamadzade shabestari
Street address
sajjad bolivard-banafshe 13 street -block 32
City
mashhad
Province
Razavi Khorasan
Postal code
9187753830
Phone
+98 901 320 2144
Email
naseroddinm911@mums.ac.ir
Web page address
https://fa.irct.ir/user/trial/67531/update/recruitment_center

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mahmoud mohamadzade shabestari
Street address
sajjad bolivard-banafshe 13 street -block 32
City
mashhad
Province
Razavi Khorasan
Postal code
9187753830
Phone
+98 901 320 2144
Email
naseroddinm911@mums.ac.ir
Web page address
https://fa.irct.ir/user/trial/67531/update/sponsor
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
medical university of mashhad
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
moustafa nassereddine
Position
cardiology resident
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
sajjad bolivard-banafshe 13 street -block 32
City
mashhad
Province
Razavi Khorasan
Postal code
9187753830
Phone
+98 51 3763 9992
Email
naseroddinm911@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mahmod mohamadzadeh shabestari
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
emam reza hospital
City
mashhad
Province
Razavi Khorasan
Postal code
9187753830
Phone
+98 915 156 6747
Email
shabestrarim@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mahmoud mohamadzade shabestari
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
imam reza hospital
City
mashhad
Province
Razavi Khorasan
Postal code
9187753830
Phone
+98 915 156 6747
Email
shabestarim@mums.ac.ir

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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all data can be shared after deidentifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available for researchers working in academic and scientific institutions
Under which criteria data/document could be used
To investigate the superiority of the snuff box catheterization method compared to the proximal method
From where data/document is obtainable
naseroddinm911@mums.ac.ir
What processes are involved for a request to access data/document
After receiving the e-mail containing the details of the applicant, the documents will be sent within 7 working days
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