Evaluation of right and left ventricular size and function using echocardiography in adults, one month and six months after percutaneous atrial septal defect (ASD) closure
Due to the importance of evaluating ventricular function after ASD closure and also due to the fact that studies in this case are limited and incomplete, especially in adults, we decided to evaluate the size and function of the right and left ventricles using echocardiography in adults at one month and six months after percutaneous ASD closure.
Design
clinical trial without control group, non-randomized, on 30 patients, followed for 6 months
Settings and conduct
In this study, 30 patients whose ASD was closed by percutaneous method and who are over 18 years old and willing to participate in the study are examined. A checklist is designed for all participants in the study, which includes demographic information and echocardiographic data before the intervention and the date of the percutaneous intervention. Patients are then followed up for a period of 6 months.
Participants/Inclusion and exclusion criteria
All adult patients who refer to Chamran Hospital for ASD closure and are treated with percutaneous method.
Inclusion criteria:
1. Patients whose ASD is closed by the percutaneous method.
2. Patients who are willing to participate in the study.
3. Patients over 18 years of age.
4. Have preoperative echocardiography.
5. Absence of concomitant heart defects
Exclusion criteria:
1. Patients who are not willing to participate in further study.
Intervention groups
The intervention group will undergo ASD closure intervention percutaneously. Then, the size and function of the left and right ventricles are evaluated as an indicator of the effectiveness of the intervention.
Main outcome variables
Basal size; Middle size; longitudinal size; left ventricular output; Left ventricular volume; Diastolic dysfunction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210426051085N1
Registration date:2021-05-03, 1400/02/13
Registration timing:registered_while_recruiting
Last update:2021-05-03, 1400/02/13
Update count:0
Registration date
2021-05-03, 1400/02/13
Registrant information
Name
Fateme Jalalidil
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4333 8356
Email address
fatemeh.j.cardio95@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-01, 1400/02/11
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of right and left ventricular size and function using echocardiography in adults, one month and six months after percutaneous atrial septal defect (ASD) closure
Public title
Evaluation of left and right ventricular size and function after percutaneous atrial septal defect closure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients whose ASD is closed by percutaneous method.
Patients who consent to participate in the study.
Absence of concomitant heart defects
Patients older than 18 years
Have preoperative echocardiography.
Exclusion criteria:
Patients who tend to leave the study at any stage.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan university of medical sciences, Hezar jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-10-04, 1399/07/13
Ethics committee reference number
IR.MUI.MED.REC.1399.576
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
basal size
Timepoint
Before intervention, immediately after intervention, one month after intervention and 6 months after intervention
Method of measurement
Ecocardiography
2
Description
Middle size
Timepoint
Before intervention, immediately after intervention, one month after intervention and 6 months after intervention
Method of measurement
Ecocardiography
3
Description
Longitudinal size
Timepoint
Before intervention, immediately after intervention, one month after intervention and 6 months after intervention
Method of measurement
Ecocardiography
4
Description
Left ventricle output
Timepoint
Before intervention, immediately after intervention, one month after intervention and 6 months after intervention
Method of measurement
Ecocardiography
5
Description
Left ventricle volume
Timepoint
Before intervention, immediately after intervention, one month after intervention and 6 months after intervention
Method of measurement
Ecocardiography
6
Description
Diastolic dysfunction
Timepoint
Before intervention, immediately after intervention, one month after intervention and 6 months after intervention