| CTRI Number |
CTRI/2025/09/095455 [Registered on: 29/09/2025] Trial Registered Prospectively |
| Last Modified On: |
25/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study on Ultrasound vs. CT Scan for Detecting Complex Heart Disease in Children |
|
Scientific Title of Study
|
A Comparative study of 2D Echocardiography and CT Pulmonary angiography for detection of complex congenital heart disease in pediatric population - A one-year cross-sectional study at tertiary care center |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MIR SAJID RAZA |
| Designation |
MD Paediatrics |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Paediatrics, Jwaharlal Nehru Medical College, Nehru Nagar, KLE Hospital road Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9901843463 |
| Fax |
|
| Email |
sajidraza99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VEERESH MANVI |
| Designation |
PROFESSOR |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Paediatrics, Jwaharlal Nehru Medical College, Nehru Nagar, KLE Hospital road Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9164000009 |
| Fax |
|
| Email |
manviveeresh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MIR SAJID RAZA |
| Designation |
MD Paediatrics |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Paediatrics, Jwaharlal Nehru Medical College, Nehru Nagar, KLE Hospital road Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9901843464 |
| Fax |
|
| Email |
sajidraza99@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr.Prabhakar Kore Hospital, Jawaharlal Nehru Medical College KLE University, Belagavi, Karnataka, India
590010 |
|
|
Primary Sponsor
|
| Name |
DR MIR SAJID RAZA |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College KLE university Belagavi, karnataka, india.
590010 |
| Type of Sponsor |
Other [Principal investigator ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mir Sajid Raza |
KLEs Dr. PRABHAKAR KORE HOSPITAL BELAGAVIM |
DEPARTMENT OF PEDIATRICS, KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH, JAWAHARLAL NEHRU MEDICAL COLLEGE, BELAGAVI
Belgaum
KARNATAKA |
9901843464
sajidraza99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2D Echocardiography |
The comparator agent is 2D Echocardiography (2D Echo). It is a non-invasive, ultrasound-based imaging tool and is the first-line investigation for congenital heart disease in children. It helps detect septal defects, valvular abnormalities, chamber size, and blood flow patterns. It is safe, radiation-free, repeatable, and cost-effective. However, it is operator-dependent, limited by poor acoustic windows, and cannot adequately assess extra-cardiac vascular structures. |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Pediatric patients under 18 years of age with:
Complex cyanotic congenital heart disease with difficult PA anatomy.
Complex cyanotic heart defect with poor ECHO window.
Congenital heart defect in whom vascular rings, arch of aorta hypoplasia, and
interrupted aortic arch are suspected.
Complex aberrant pulmonary vein drainage and an unusual type of TAPVC
Rare cases of abnormal systemic venous drainage, pulmonary arterio-venous
fistula, and pulmonary thromboembolism are suspected.
|
|
| ExclusionCriteria |
| Details |
Patients with renal failure in whom serum creatinine is higher, and contrast
administration is not advisable.
Those who have undergone diagnostic cardiac catheterisation and pulmonary artery
anatomy have been well defined.
Complex cyanotic congenital heart defects in whom ECHO can identify the
anatomy without any ambiguity
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the diagnostic accuracy of two-dimensional echocardiography (2D Echo) and computed tomography (CT)pulmonary angiography in detecting complex CHD in children |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To know the correlation between the findings on two-dimensional echocardiography (2D Echo) and computed tomography (CT)pulmonary angiography with intra-operative findings. |
one year |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a comparative cross sectional investigation designed to evaluate the diagnostic accuracy of 2D Echocardiography and CT Pulmonary Angiography in detecting complex congenital heart disease in the pediatric population at a tertiary care center over one year. Congenital heart disease is a leading cause of morbidity and mortality in children, and early diagnosis is crucial for improving survival, treatment outcomes, and quality of life. 2D Echocardiography is the standard first line diagnostic tool due to its safety and radiation free nature. However, it has limitations in assessing extra cardiac vascular structures and is highly operator dependent. CT Pulmonary Angiography, with its three dimensional imaging and high spatial resolution, provides accurate anatomical assessment of intra and extra cardiac structures, thereby enhancing preoperative planning and overall management. The study aims to compare these two modalities to determine their relative effectiveness, accuracy, and utility in clinical decision making for pediatric congenital heart disease for the study. |