| CTRI Number |
CTRI/2024/06/068233 [Registered on: 03/06/2024] Trial Registered Prospectively |
| Last Modified On: |
02/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation between high sensitive cardiac troponin T levels and myocardial injury in children with acyanotic congenital heart diseases between 1 to 5 years of age - |
|
Scientific Title of Study
|
Correlation between high sensitive cardiac troponin T levels and myocardial injury in children with acyanotic congenital heart diseases between 1 to 5 years of age - a one year case control study at a tertiary care centre |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Papani Sruthika |
| Designation |
PG Paediatrics JR1 |
| Affiliation |
Jawarhal nehru medical college |
| Address |
department of paediatrics,
JNMC, kle university
Belagavi, Karnataka 590010
Jnmc college, KLE University, Nehru Nagar, kle hospital road, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
6363256784 |
| Fax |
|
| Email |
papani.sruthika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veeresh Manvi |
| Designation |
professor |
| Affiliation |
Jawarhal nehru medical college |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical college, Nehru nagar, KLE hospital road, Belagavi, Karnataka 590010
Department of Paediatrics, Jawaharlal Nehru Medical college, Nehru nagar, KLE hospital road, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9164000009 |
| Fax |
|
| Email |
manviveeresh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Papani Sruthika |
| Designation |
PG Paediatrics JR1 |
| Affiliation |
Jawarhal nehru medical college |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical college, Nehru nagar, KLE hospital road, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
6363256784 |
| Fax |
|
| Email |
papani.sruthika@gmail.com |
|
|
Source of Monetary or Material Support
|
| kle dr prabhakar kore hospital, jnmc, belagavi, karnataka 590010 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru medical college |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical college, Nehru nagar, KLE hospital road, Belagavi, Karnataka 590010 drpapani sruthika 6363256784
papani.sruthika@gmail.com |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| drpapani sruthika |
KLE dr prabhakar kore hospital, belagavi |
Department of Paediatrics, Jawaharlal Nehru Medical college, Nehru nagar, KLE hospital road, Belagavi, Karnataka 590010
Belgaum
KARNATAKA |
6363256784
papani.sruthika@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: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
children between 1 to 5 years of age who are a known case of acyanotic congeniytal heart disease will be taken as cases. the controls will be healthy children without acyanotic congenital heart diseases. |
|
| ExclusionCriteria |
| Details |
children between 1 to 5 years of age who are in septic shock, active NEC, infective endocarditis, renal failure, lung failure, on cardiotoxic drugs, intracranial haemorrhage, heart failure due to any cardiomyopathies, pericarditis or coronary artery diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to find out if children with acyanotic congenital heart diseases have raised high sensitive cardiac troponin T levels which correlates to myocardial injury |
to find out if children with acyanotic congenital heart diseases have raised high sensitive cardiac troponin T levels which correlates to myocardial injury will be found out at baseline after investigation results come |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the levels of high sensitive cardiac troponin T in children with different types of acyanotic congenital heart diseases |
1 year |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
13/06/2024 |
| 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
|
Most congenital heart diseases do not have any identifiable etiology and there is no effective strategy for their prevention. Vast majority of acyanotic congenital heart diseases are diagnosed early in high-income households. Low and middle income households are where most births happen and a lack of awareness and delay in diagnosis is a significant risk to the survival of the children. Furthermore there is no established reference value of high sensitive cardiac troponin T values in paediatric age group which limits the use of this investigation hence delaying diagnosis and treatment. By estimating the levels of high sensitive cardiac troponin T and correlating it with myocardial injury, apositive correlation can ensure early surgical intervention of acyanotic congenital heart diseases before irreversible damage occurs. |