A clinical trial to compare the diagnostic quality of CT pulmonary angiogram images between standard and reduced doses of contrast agent in patients with the risk of pulmonary embolism
To compare the diagnostic quality of CT pulmonary angiogram images between standard and reduced doses of contrast agent in patients with the risk of pulmonary embolism
Design
In this research, 50 patients with the risk of pulmonary embolism visiting the Radiology Department of Imam Reza Hospital were chosen randomly and assigned into control and intervention groups. A code was allocated to each of the participants.
Settings and conduct
Patients with the risk of pulmonary embolism presenting to the Radiology Department of Imam Reza Hospital, Mashhad, Iran, are chosen as the participants of the study. In this double-blind study, the participants and radiologist responsible for data collection are unaware of the dosage.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient with the risk of pulmonary embolism; Weight between 60 and 80 kg.
Exclusion criteria: Having acute heart failure; Being CV-line for contrast agent injection.
Intervention groups
The control group: CT pulmonary angiography will be performed with the standard dose of contrast agent (100-120 cc), concentration of 320 mg/ml, and rotation period of 0.75 s for patients with the risk of pulmonary embolism.
The intervention group: CT pulmonary angiography will be carried out with the reduced dose of contrast agent (50-60 cc), concentration of 320 mg/ml, and rotation period of 0.75 s for patients with the risk of pulmonary embolism.
Main outcome variables
Evaluation and comparison of the enhancement of the contrast of the aortic arteries, pulmonary truncus, and the right and left main pulmonary arteries based on Hansfild unit between the intervention and control groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180203038595N1
Registration date:2018-02-15, 1396/11/26
Registration timing:prospective
Last update:2018-02-15, 1396/11/26
Update count:0
Registration date
2018-02-15, 1396/11/26
Registrant information
Name
Mansoure Ahrari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2000
Email address
ahraim931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the diagnostic quality of CT pulmonary angiogram images between standard and reduced doses of contrast agent in patients with the risk of pulmonary embolism
Public title
The diagnostic quality of CT pulmonary angiogram images in patients with the risk of pulmonary embolism
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with the risk of pulmonary embolism
Weight between 60 and 80 kg
Exclusion criteria:
Having acute heart failure
Being CV-line for contrast agent injection
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and radiologist responsible for data collection are unaware of the dosage
Placebo
Not used
Assignment
Other
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
9138813944
Approval date
2017-09-27, 1396/07/05
Ethics committee reference number
IR.MUMS.fm.1396.385
Health conditions studied
1
Description of health condition studied
Pulmonary embolism
ICD-10 code
I26
ICD-10 code description
Pulmonary embolism
Primary outcomes
1
Description
The enhancement of the contrast of the aortic arteries
Timepoint
After taking CT pulmonary angiogram images
Method of measurement
Based on Hansfild unit
2
Description
The enhancement of the pulmonary truncus
Timepoint
After taking CT pulmonary angiogram images
Method of measurement
Based on Hansfild unit
3
Description
The enhancement of the right and left main pulmonary arteries
Timepoint
After taking CT pulmonary angiogram images
Method of measurement
Based on Hansfild unit
Secondary outcomes
empty
Intervention groups
1
Description
Control group: CT pulmonary angiography will be performed with the standard dose of contrast agent (100-120 cc), concentration of 320 mg/ml, and rotation period of 0.75 s for patients with the risk of pulmonary embolism
Category
Diagnosis
2
Description
Intervention group: CT pulmonary angiography will be carried out with the reduced dose of contrast agent (50-60 cc), concentration of 320 mg/ml, and rotation period of 0.75 s for patients with the risk of pulmonary embolism
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mansoure Ahrari
Street address
Imam Reza Hospital, Ibn Sina Avenue, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2000
Email
ahraim931@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
9138813944
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
Mansoure Ahrari
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Imam Reza Hospital, Ibn Sina Avenue, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 915 113 1491
Email
ahraim931@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mansoure Ahrari
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Imam Reza Hospital, Ibn Sina Avenue, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 915 113 1491
Email
ahraim931@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mansoure Ahrari
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Imam Reza Hospital, Ibn Sina Avenue, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 915 113 1491
Email
ahraim931@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
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
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
Mansoure Ahrari provides the analysis code to the applicants via email: ahraim931@mums.ac.ir
What processes are involved for a request to access data/document
Data collection was done for 3 months, data were collected one month, statistical analysis of one month, information dissemination as a article six months