Determination and comparison of right and left ventricular function by speckle tracking in children before and after percutaneous atrial septal defect (ASD) closure.
Determination and comparison of right and left ventricular function using speckle tracking in children before and after percutaneous atrial septal defect (ASD) closure.
Design
Clinical trial with control group, 26 patients, with parallel groups-Non-randomized
Settings and conduct
Patients with atrial septal defect before, one day and one month after closure of this defect are evaluate at Imam Hossein Hospital in Isfahan by Speckle Tracking.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
age less than 18 years,
having detected the atrial septal defect,
satisfaction of the parent or the patient himself to participate in this study,
Not having complex cardiac defects
Intervention groups
Intervention group : children with atrial septal defect less than 18 years of age that had atrial septal defect closure percutaneously had evaluated before and after procedure by Speckle Tracking.
Control group: in control group Speckle Tracking estimated one time for comparison.
Main outcome variables
ventricular function
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20170801035441N2
Registration date:2018-10-20, 1397/07/28
Registration timing:retrospective
Last update:2018-10-20, 1397/07/28
Update count:0
Registration date
2018-10-20, 1397/07/28
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3335 5881
Email address
m.ghaderian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
2017-06-22, 1396/04/01
Actual recruitment end date
2018-03-21, 1397/01/01
Trial completion date
2018-09-22, 1397/06/31
Scientific title
Determination and comparison of right and left ventricular function by speckle tracking in children before and after percutaneous atrial septal defect (ASD) closure.
Public title
Using of Speckle Tracking in atrial septal defect closure in pediatric
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Age under 18 years
Having an atrial septal defect which diagnosed by a pediatric cardiologist and has indication for closure.
Consent of the parent or the patient to participate in this study
do not have complex heart defects.
Exclusion criteria:
Age
To 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
26
Actual sample size reached:
26
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Esfahan University of Medical Science, Azadi Square, Hezar Jerib st
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2017-11-29, 1396/09/08
Ethics committee reference number
IR.MUI.REC.1396.3.721
Health conditions studied
1
Description of health condition studied
َAtrial Septal Defect
ICD-10 code
Q21.1
ICD-10 code description
Atrial septal defect
Primary outcomes
1
Description
ventricular function
Timepoint
Before, one day and one month after atrial septal defect closure
Method of measurement
Echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Interventional group: Patients who have been treated percutaneously using Occlutech Amplatzer (made in Germany) that had prepared are included in this study.This procedure performed in angiography operation room from femoral vein and Amplatzer implanted in the defect from this vein and standard approach and the defect resolved. Cardiac function in these patients is evaluated by Speckle Tracking V7 Samsung echocardiography (made in Korea) . This method could evaluate cardiac function regionally and globally.
Category
Diagnosis
2
Description
Control group: The equal number of healthy children who were matched with the control group were examined by echocardiography and compared with the intervention group.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hosein hospital
Full name of responsible person
Mehrdad Memarzade
Street address
Emam Hosein hospital, Emam Khomeini street
City
Esfahan
Province
Isfehan
Postal code
8195100000
Phone
+98 31 3387 6006
Fax
+98 31 3387 5998
Email
emamhossein_hospital@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjouye Javanmard
Street address
Esfahan University of Medical Science, Hezar Jerib St
City
Esfahan
Province
Isfehan
Postal code
8137675961
Phone
+98 31 3792 3060
Fax
+98 31 3668 7898
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Ghaderian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
no. 34, alley no. 16, Chaharbaghe Paein st
City
Esfahan
Province
Isfehan
Postal code
8137675961
Phone
+98 31 3335 5881
Email
ghader_45@yahoo.co.uk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Ghaderian
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
no. 34, alley no. 16, Chaharbaghe Paein st
City
Esfahan
Province
Isfehan
Postal code
8137675961
Phone
+98 31 3335 5881
Email
ghader_45@yahoo.co.uk
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Ghaderian
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
No. 34, alley 16, Chaharbaghe Paein St
City
Esfahan
Province
Isfehan
Postal code
8137675961
Phone
+98 31 3335 5881
Fax
+98 31 3386 6266
Email
Ghader_45@yahoo.co.uk
Web page address
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
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
All data after unrecognizable person
When the data will become available and for how long
One year after study
To whom data/document is available
The data is available to researchers working in medical sciences
Under which criteria data/document could be used
Persons who working in pediatric cardiology and echocardiography
From where data/document is obtainable
+989131004787
Mehdi Ghaderian
What processes are involved for a request to access data/document
After telephone and confirmation, data will be transferred.