Protocol summary

Summary
The aim of this study was to compare patient radiation dose in coronary computed tomography angiography in 100 and 120 kilo Voltage in those with Body Mass Index less than 29. Inclusion criteria is weight below 85 kg, body mass index less than 28 kg/m2 and exclusion criteria are coronary calcium score greater than the maximum limit of Computed Tomography Angiography (300 (Agatston Units) in a vessel or in total vessels Agatston Units 1200). Population of this study are patients those refer to Golestan hospital for coronary CT angiography. Our study cases is 114 patients. our intervention is reduction of Computed tomography voltage.primary outcome is changing amount of patient radiation dose that measure immediately after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013121015750N1
Registration date: 2014-07-05, 1393/04/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-07-05, 1393/04/14
Registrant information
Name
Seyyed Mohammad Ali Maashi
Name of organization / entity
Ahvaz Jondi shapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3154
Email address
smamaashi2479@gmail.com
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondi Shapour University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-04-20, 1393/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of radiation dose of coronary computed tomography angiography with 100 and 120 kilo voltage in patients with body mass index less than 29
Public title
The comparison of radiation dose of coronary computed tomography angiography with 100 and 120 kilo voltage in patients with body mass index less than 29
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria :patients who are candidates for coronary Computed Tomography Angiography in Ahwaz Golestan Hospital ; having conscious satisfaction ;weight under 85 KG; have a body mass index less than 28 ; exclusion criteria :Patients with body weight above 85 kg; Body Mass Index higher than 28; coronary calcium score greater than the maximum limit of Computed Tomography Angiography (300 (Agatston Units in one vessel or in total 1200 Agatston Units);renal dysfunction (serum creatinine greater than 1.3 mili grams per deciliter); hyperthyroidism; Known hypersensitivity reaction to iodine-containing contrast agents; Pregnancy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz University of Medical Sciences Ethics Committee
Street address
Central Library, University of Medical Sciences of Ahvaz, Golestan
City
Ahvaz
Postal code
Approval date
2014-01-25, 1392/11/05
Ethics committee reference number
ajums.rec.1392.272

Health conditions studied

1

Description of health condition studied
cardiac diseases
ICD-10 code
I20,I21,I2
ICD-10 code description
Ischaemic heart diseases

Primary outcomes

1

Description
Patient radiaition exposure dose
Timepoint
Immediately after intervention
Method of measurement
Using the formula Dose Length Product * E ​​ - mili Sivert

Secondary outcomes

1

Description
Image Quality
Timepoint
Immediately after study
Method of measurement
with Contrast to Noise Ratio, IMAGE NOISE ( Hounsfield units),Signal to Noise Ratio,Image Quality

Intervention groups

1

Description
control group:62 patients-using 120 kilo voltage for Computed Tomography Angiography(standard setting) for one time
Category
Other

2

Description
Intervention group:52 patients-using 100 kilo voltage for Computed Tomography Angiography for one time
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Dr Mohammad Davodi
Street address
Golestan Hospital, Golestan, Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
research of Ahvaz University of Medical Sciences
Full name of responsible person
DR Nader Saki
Street address
Central Library, Ahvaz University of Medical Sciences, Golestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
research of Ahvaz 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
Ahvaz Jondi Shapour University of Medical Sciences
Full name of responsible person
Dr Mohammad Davodi
Position
radiology specialist
Other areas of specialty/work
Street address
Number57, West elham avenue, Kianpars, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1374 3034
Fax
Email
Mohammaddavoodi47@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jondi Shapour University of Medical Sciences
Full name of responsible person
Dr Mohammad Davodi
Position
radiology specialist
Other areas of specialty/work
Street address
Number57, West Elham avenue, Kianpars, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1374 3034
Fax
Email
Mohammaddavoodi47@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jondi Shapour University of Medical Sciences
Full name of responsible person
Dr Mohammad Davodi
Position
radiology specialist
Other areas of specialty/work
Street address
Number57, West Elham avenue, Kianpars, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1374 3034
Fax
Email
Mohammaddavoodi47@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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