Evaluating the diagnostic performance of low-dose high-pitch CT angiography in evaluating pulmonary thromboembolism
Design
Patients referring to the Imam Reza hospital imaging center (Mashhad) during the study period will be enrolled in the study. After obtaining written consent, the patients are randomized into two groups. One group will be imaged routinely and imaging will be performed with high-pitch, low-dose, free breathing in the other group.
CT angiographic images will be blinded and interpreted by radiologists. Image quality, contrast to noise ratio, signal to noise ratio, and motion artifact will be recorded. Patient's effective dose will also be calculated using imaging data.
Settings and conduct
The study will be conducted in the Radiology Department, Imam Reza hospital, Mashhad, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
clinical suggestion of pulmonary thromboemboli
age more than 18 year-old
weight over 45 kg
conscious patients
Exclusion criteria:
Unconscious patient
weight over 80 kg
Allergy to contrast material
Intervention groups
Patients undergoing pulmonary CT angiography to evaluate pulmonary thromboembolism
Main outcome variables
Image quality
Signal to noise ratio
Contrast to noise ratio
Motion artifact
Patient's effective dose
Image acquisition speed
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180519039721N1
Registration date:2018-06-06, 1397/03/16
Registration timing:registered_while_recruiting
Last update:2018-06-06, 1397/03/16
Update count:0
Registration date
2018-06-06, 1397/03/16
Registrant information
Name
Bita Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5004
Email address
abbasib@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-26, 1397/03/05
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing diagnostic yield of high-pitch CT angiography with low-dose radiation and normal breathing with routine breath hold CT angiography
Public title
Low-dose, high-pitch pulmonary CT angiography in evaluating pulmonary thromboembolism
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to hold the breathing
Clinical suggestion of pulmonary thromboembolism
Conscious patient
weight over 45 kg
Exclusion criteria:
Weight over 80 kg
unconsciousness
contrast material allergy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization with 1:1 allocation
Blinding (investigator's opinion)
Triple blinded
Blinding description
The only person who knew the technique used for each patient, was the radiology technician, who saved the regarding data for further reference.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committe, Mashhd University of Medical Sciences, Mashhad, Iran.