Comparison of image quality of low voltage CT angiography (80 kilovoltage) with standard condition (100 kilovoltage) in patients suspicious to pulmonary emboli
The aim of the present study is to compare the image quality of CT angiography of 80 kilovoltage with 100 kilovoltage (standard protocol) in suspicious patients to pulmonary emboli. In this triple blind single center clinical trial, 142 patients suspicious to pulmonary emboli referring to Golestan Hospital of Ahvaz city, in two parallel groups with equal sample size, will be evaluated. In intervention group: pulmonary CT Aangiography will be done by 80 kilovoltage condition and in control group: Pulmonary CT Aangiography will be done by 100 kilovoltage condition will be done. Inclusion criteria: written informed consent of the patient and weight lower than 110 kg and exclusion criteria is tendency of the patients to quit from the study every time he/she wants. Main outcome variables are number of sizable arteries in different segments of lungs, pulmonary vascular enhancement, image noise and image quality score.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208084811N2
Registration date:2013-05-21, 1392/02/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-21, 1392/02/31
Registrant information
Name
Ali Kabir
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 1993
Email address
a.kabir@nhri.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapour University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2013-04-20, 1392/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of image quality of low voltage CT angiography (80 kilovoltage) with standard condition (100 kilovoltage) in patients suspicious to pulmonary emboli
Public title
Comparing image quality of low voltage CT angiography with 100 kilovoltage
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: written informed consent of the patient, weight lower than 110 kg.
Exclusion criteria: tendency of the patients to quit from the study every time he/she wants (causes of this tendency will be asked to be able for doing sensitivity analysis)
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
142
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients are allocated to each group based on block randomization method. Patient, physician (who reports the CT Angiographies) and person who do statistical analysis are all blind to the voltage used in each case. All images are coded by a colleague who is not involved in taking and reporting graphies or analyzing data. So, the study is triple blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapour University of Medical Sciences
Street address
1st Floor, Ahvaz Jundishapour University of Medical Sciences, Vice Chancellor for Research, University city
City
Ahvaz
Postal code
61357-15794
Approval date
2012-07-16, 1391/04/26
Ethics committee reference number
ajums.REC.1392.30
Health conditions studied
1
Description of health condition studied
Pulmonary emboli
ICD-10 code
I26
ICD-10 code description
Pulmonary embolism
Primary outcomes
1
Description
Number of sizable arteries in different segments of lungs
Timepoint
after CT angiography
Method of measurement
CT Angiography
2
Description
Pulmonary vascular enhancement
Timepoint
after CT angiography
Method of measurement
CT Angiography
3
Description
Image noise
Timepoint
after CT angiography
Method of measurement
CT Angiography
4
Description
Image quality score
Timepoint
after CT angiography
Method of measurement
CT Angiography
Secondary outcomes
1
Description
Age
Timepoint
Before intervention
Method of measurement
Taking history from the patient
2
Description
Gender
Timepoint
Before intervention
Method of measurement
Taking history from the patient
3
Description
Weight
Timepoint
Before intervention
Method of measurement
Taking history from the patient
4
Description
Height
Timepoint
Before intervention
Method of measurement
Paper meter
5
Description
Underlying diseases
Timepoint
Before intervention
Method of measurement
Taking history from the patient
6
Description
smoking
Timepoint
Before intervention
Method of measurement
Taking history from the patient
Intervention groups
1
Description
Intervention group: Pulmonary CT Aangiography will be done by 80 kilovoltage condition
Category
Diagnosis
2
Description
Control group: Pulmonary CT Aangiography will be done by 100 kilovoltage condition
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Dr Sudabeh BlashAbadi
Street address
Radiology Ward, Golestan Hospital, Golestan Blvd.
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Dr Mostafa Feghhi
Street address
Vice chancellor for research, Ahvaz Jundishapour University of Medical Sciences, University city
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jundishapour University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Kabir
Position
MD, MPH
Other areas of specialty/work
Street address
Department of Epidemiology,Faculty of Public Health,Shahid Beheshti University of Medical Sciences,Daneshjoo Blvd.,Velenjak
City
Tehran
Postal code
Phone
+98 21 2243 1993
Fax
Email
aikabir@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Kabir
Position
MD, MPH
Other areas of specialty/work
Street address
Department of Epidemiology,Faculty of Public Health,Shahid Beheshti University of Medical Sciences,Daneshjoo Blvd.,Velenjak
City
Tehran
Postal code
Phone
+98 21 2243 1993
Fax
Email
aikabir@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
MD, MPH
Full name of responsible person
Ali Kabir
Position
Shahid Beheshti University of Medical Sciences
Other areas of specialty/work
Street address
Department of Epidemiology,Faculty of Public Health,Shahid Beheshti University of Medical Sciences,Daneshjoo Blvd.,Velenjak
City
Tehran
Postal code
Phone
+98 21 2243 1993
Fax
Email
aikabir@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)