Comparison of rotational angiography with standard (traditional) angiography in patients referred to the Cardiac Center affiliated to Qazvin University of Medical Sciences in 2020-2021
The aim of this study was to compare rotational angiography with standard (traditional) angiography in patients.
Design
In this clinical trial, 64 patients with inclusion criteria were included in the study. Patients were randomly divided into two groups of 32 patients. The first group is treated with standard (traditional) angiography and the second group is treated with rotational angiography. The study is a blind study and trial phase 3. Randomization is performed using random sequence generation software. In this way, information such as sample size and number of groups is given to the software and the software provides a table of random numbers, each of which is randomly assigned the letters A and B. In this study, A numbers in the standard (traditional) angiography group and B numbers in the rotational angiography group.
Settings and conduct
In this one-way blind clinical trial, 64 angiography candidates with admission requirements who referred to Bu Ali Sina Hospital in Qazvin, were admitted to the study. In this study, only the data analyzer is blind. For the purpose of blinding, no information about the type of angiographic procedure is available in the file available to the analyzer.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 18 years; Early diagnosis of coronary artery disease; Angiography through the right femoral artery. Exclusion criteria: dissatisfaction with this method; Emergency angiography; Hemodynamic disorders; The patient's high weight.
Intervention groups
In one group, angiography is performed by conventional method (traditional) and in the other group by rotation.
Main outcome variables
The amount of contrast agent injected; The amount of radiation emitted; Fluoroscopic duration; Duration of the procedure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210215050365N1
Registration date:2021-06-01, 1400/03/11
Registration timing:registered_while_recruiting
Last update:2021-06-01, 1400/03/11
Update count:0
Registration date
2021-06-01, 1400/03/11
Registrant information
Name
Mohammadreza Kheiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 3036
Email address
afikhob56@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-20, 1400/02/30
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of rotational angiography with standard (traditional) angiography in patients referred to the Cardiac Center affiliated to Qazvin University of Medical Sciences in 2020-2021
Public title
Comparison of rotational angiography with standard (traditional) angiography
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Early diagnosis of coronary artery disease
Angiography through the right femoral artery
Exclusion criteria:
Dissatisfaction with the procedure
Emergency angiography
Hemodynamic disorders
The patient's high weight
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Due to the ease of use and cost savings in time, participants were divided into two groups using random sequence generation software. In this way, information such as sample size and number of groups is given to the software and the software provides a table of random numbers, each of which is randomly assigned the letters A and B. In this study, A numbers are in the standard (traditional) angiography group and B numbers are in the rotational angiography group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study was performed blindly. In this study, the data analyzer did not know the type of method used on patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar blvd
City
Qazvin
Province
Qazvin
Postal code
3415613911
Approval date
2020-02-10, 1398/11/21
Ethics committee reference number
IR.QUMS.REC.1398.308
Health conditions studied
1
Description of health condition studied
Angiography
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of contrast agent injected
Timepoint
After angiography
Method of measurement
Based on the amount of cc used by the operator
2
Description
The amount of radiation emitted
Timepoint
After angiography
Method of measurement
It is recorded by angiography device.
3
Description
Fluoroscopic duration
Timepoint
After angiography
Method of measurement
It is recorded by angiography device.
4
Description
It is recorded by angiography device.
Timepoint
After angiography
Method of measurement
It is recorded by angiography device.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Rotational angiography
Category
Treatment - Surgery
2
Description
Control group: standard angiography (common)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali Sina Hospital
Full name of responsible person
Mohammadreza Kheiri
Street address
Boo-Ali Hospital, Boo-Ali St., Qazvin
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2931
Email
afikhob56@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Mohammad Mahdi Emamjomeh
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar blvd
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3333 6001
Email
research.dpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Mohammadreza Kheiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Qazvin University of Medical Sciences, Shahid Bahonar blvd
City
Qazvin
Province
Qazvin
Postal code
3413786313
Phone
+98 28 3333 6001
Email
afikhob56@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Daei
Position
Assistant Professor of Interventional Cardiology
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Boo-Ali Hospital, Boo-Ali St., Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2931
Email
afikhob@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammadreza Kheiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Boo-Ali Hospital, Boo-Ali St., Qazvin
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2931
Email
afikhob56@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
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
The collected information is in the form of a questionnaire and is statistically analyzed.
When the data will become available and for how long
The start of the access period is one year after the results are published.
To whom data/document is available
For cardiologists and researchers working in academic institutions
Under which criteria data/document could be used
Users can evaluate the study path and process.
From where data/document is obtainable
For information, refer to Dr. Mohammad Reza Kheiri. The communication channels are in the following order: by e-mail to the address: afikhob56@gmail.com or refer to and contact the Bu Ali Sina Hospital in Qazvin at the address: Qazvin, Bu Ali Street. Phone: 33332930-028 Postal address: 86165 - 34137
What processes are involved for a request to access data/document
After sending the e-mail, the requested information will be reviewed by the facilitator and the person responsible for the scientific response of the study. At your discretion, the requested information will be sent within 10 days after receiving the email.