Incidence of radial artery occlusion in radial access angiography compared with access for angigraphy
Design
Two arm parallel group randomised trial without blinded postoperative in 96patient
Settings and conduct
This study will be performed on 100 patients referred to the angiography department of Imam Khomeini Hospital in Ahvaz. All patients are free to participate in the study. Eligible patients enter the study after obtaining informed and written consent. Individuals are randomly divided into two groups.
This study is performed on 100 consecutive patients who are candidates for coronary catheterization in Imam Medical Center. In this study, only the righ distal transradial accesss(dTRA )is used. The demographic characteristics of the patients are fully recorded. Examined by ultrasound.
Other side effects such as pain, hematoma and ischemic symptoms are also studied and recorded in the individual.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patient to participate in the study, the presence of a normal heartbeat in the radial artery and snuffbox area
Exclusion criteria: Patients with unstable hemodynamic status at the beginning of the study, upper limb vascular disorders, prominent deformity in the hand, recent fracture of the scafoid
Intervention groups
Control group: The group that undergoes angiography of the radial artery in the wrist area
Intervention group: The group undergoing radial artery angiography in the snuffbox
Main outcome variables
Radial artery thrombosis;hematom;pain;ischemia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201119049437N1
Registration date:2021-01-06, 1399/10/17
Registration timing:registered_while_recruiting
Last update:2021-01-06, 1399/10/17
Update count:0
Registration date
2021-01-06, 1399/10/17
Registrant information
Name
mohamadreza Afshani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 8037
Email address
afshani-mr@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-10, 1399/09/20
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Incidence of radial artery occlusion in radial access angiography compared with access for angiography
Public title
Incidence of radial artery occlusion in radial access angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patient Refer to hospital and candidate for angiography
Exclusion criteria:
Patient discharged before 24hr from angiography and cannot sonography
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization
Random unit: individual
Randomization tool: Random number table
How to randomize a random sequence: First, we predetermine the table numbers to read (up, down, left and right). The even or odd numbers are in the control group or the case group. Then we put them on one of the numbers and in one Moves in predetermined directions and records numbers and assigns them to different groups.
Hiding: Using opaque envelopes sealed with a random sequence. First the random sequence is specified with a table of random numbers and then a number of envelopes are prepared and each random sequence is recorded on a card and the cards are inside the envelope. The letters are placed in order and finally pasted in envelopes and placed inside a box, and after each patient's visit, one of the envelopes is opened in order, the assigned group of the participant is revealed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
No
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of ahvaz University of medical Sciences
Street address
West Azadegan
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۹۳۶۷۳۱۱۱
Approval date
2020-10-22, 1399/08/01
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1399.073
Health conditions studied
1
Description of health condition studied
Angigraphy radial access
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Radial artery thrombosis
Timepoint
Sonography of radial artery 24hr after angiography
Method of measurement
Sonography
Secondary outcomes
1
Description
Hematoma
Timepoint
24hr after angiography
Method of measurement
Sonography and observation
Intervention groups
1
Description
Intervention group:People who undergo snuff box angiography undergo radial ultrasound after 24 hours to assess radial artery thrombosis, and other complications such as pain, hematoma, and ischemic symptoms are observed. To reach the snuffbox area, patients' left hand is gently bent toward their right groin, and then the left hand is gently opened, with the thumb under the other four fingers and the sunken area is identified. The cardiologist is located on the patient's right side. After local anesthesia, it enters the radial artery using a 21 gauge needle at a 35 degree angle.
Category
Prevention
2
Description
Control group: People who undergo transradial angiography undergo radial ultrasound after 24 hours to evaluate radial artery thrombosis and other complications such as pain, hematoma and ischemic symptoms are observed visually. In order to reach the radial area of the patient, the patient's left palm is placed upwards and next to the patient's groin.The cardiologist is located on the right side of the patient and after local anesthesia, enters the radial canal using a 21 gauge needle at a 35 degree angle from 2 to 3 cm proximal to the styloid appendage
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam khomeini ahvaz hospital
Full name of responsible person
Seyed mohamadreza afshani
Street address
Azadegan Ave
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۹۳۶۷۳۱۱۱
Phone
+98 61 3222 2922
Email
Hadiseeghtedari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohamad reza afshani
Street address
Azadegan Ave
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۹۳۶۷۳۱۱۱
Phone
+98 61 3222 2922
Email
Hadiseeghtedari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
No
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
Ahvaz University of Medical Sciences
Full name of responsible person
Hadise eghtedari salimi
Position
Residency
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Azadegan
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
0098 61 3222922
Email
Hadiseeghtedari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hadise eghtedari salimi
Position
Residency
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Azadegan
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
0098 61 3222922
Email
Hadiseeghtedari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hadise eghtedari salimi
Position
Residency
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Azadegan
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
0098 61 3222922
Email
Hadiseeghtedari@yahoo.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
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
No - There is not 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
At the end of the study, all data can be shared after unidentified individuals and will be available through the registration of information and the results in the relevant scientific sites.
When the data will become available and for how long
From the year 1400
To whom data/document is available
Researchers working in academic institutions, physicians and medical students at different levels
Under which criteria data/document could be used
Cardiologists can access the results of our studies by email or in person or by phone to determine the angiographic procedure and the preferred method for vascular access.
From where data/document is obtainable
Mobile numbre for hadise eghtedari:09113411768
What processes are involved for a request to access data/document
Making a phone call, if the requested person is identified, they will be provided with prompt information