| CTRI Number |
CTRI/2021/08/035522 [Registered on: 09/08/2021] Trial Registered Prospectively |
| Last Modified On: |
06/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational study |
| Study Design |
Other |
|
Public Title of Study
|
A Study on Incidence of Congenital Heart Diseases in KMC Manipal, South Karnataka Region |
|
Scientific Title of Study
|
Incidence and Clinical Outcome of Congenital Heart Diseases in Tertiary Care Hospital-A Clinical Registry |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishnananda Nayak |
| Designation |
HOD and Associate Professor |
| Affiliation |
Manipal College of Health Professions MAHE |
| Address |
Department of Cardio Vascular Technology
Manipal College of Health Professions
Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9964015487 |
| Fax |
|
| Email |
krishnananda.n@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishnananda Nayak |
| Designation |
HOD and Associate Professor |
| Affiliation |
Manipal College of Health Professions MAHE |
| Address |
Department of Cardio Vascular Technology
Manipal College of Health Professions
Manipal Academy of Higher Education Manipal
KARNATAKA
576104
India |
| Phone |
9964015487 |
| Fax |
|
| Email |
krishnananda.n@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishnananda Nayak |
| Designation |
HOD and Associate Professor |
| Affiliation |
Manipal College of Health Professions MAHE |
| Address |
Department of Cardio Vascular Technology
Manipal College of Health Professions
Manipal Academy of Higher Education Manipal
KARNATAKA
576104
India |
| Phone |
9964015487 |
| Fax |
|
| Email |
krishnananda.n@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Dr Krishnananda Nayak
Department of Cardiovascular Technology
Manipal College of Health Professions
MAHE MANIPAL
MADHAV NAGAR 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Krishnananda Nayak |
| Address |
Department of Cardiovascular Technology
Manipal College of Health Professions
MAHE MANIPAL
MADHAV NAGAR 576104 |
| Type of Sponsor |
Other [self] |
|
|
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 Krishnananda Nayak |
Kasturba Hospital |
Department of Cardiology, Kasturba Hospital Manipal
Udupi
KARNATAKA |
9964015487
krishnananda.n@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I30-I52||Other forms of heart disease, (2) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
80.00 Day(s) |
| Gender |
Both |
| Details |
1. Acyanotic CHDs including (Bicuspid aortic valve, Shunt lesions, Obstructive, Regurgitation or miscellaneous lesions)
2. Cyanotic CHD
i. With normal PBF
ii. With increased PBF
iii. With decreased PBF
3. Pericardial diseases (Congenital absent pericardium, Ectopia cordis etc.)
4. Others (Rhabdomyoma)
5. Arch anomalies
6. Aberrant arch vessels
7. Coronary anomalies
8. PAPVC
|
|
| ExclusionCriteria |
| Details |
1. PFO ( Patent foramen ovale)
2. Tiny closing PDA in <3 months of age
3. Silent PDA
4. Physiological flow acceleration across branch pulmonary arteries
5. Systemic venous anomalies (of non significant physiology like isolated LSVC)
6. Isolated PAPVC without any association with any CHD
7. Arrhythmias with a structurally normal heart
8. Diagnosed cases who have undergone any kind of intervention
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The present study evaluates the spectrum epidemiology etiology clinical manifestations clinical outcome etc., of CHDs which helps to make a registry contributing to the incidence study of CHDs further |
5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
N/A |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
13/08/2021 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study evaluates the spectrum, epidemiology, etiology, clinical manifestations, clinical outcome etc. of CHDs.Objective:To asses
- The overall incidence of acyanotic and cyanotic heart diseases.
- To analyse the pattern of clinical manifestations of various forms of congenital heart diseases of any age group.
|