| CTRI Number |
CTRI/2024/12/077519 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between fat distributed around the heart with blood glucose, cholesterol levels in patient undergoing CT-angiogram |
|
Scientific Title of Study
|
Correlation of epicardial adipose tissue with metabolic profile in patients undergoing CT-angiogram |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EAT-02, Version 1.3, dated 09 October 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vanshika Karnwal |
| Designation |
Student |
| Affiliation |
Narayana Hrudayalaya Institute of Allied Health Sciences |
| Address |
Department of clinical research (basement), Narayana Institute of Cardiac Sciences ,No. 258/A, Bommasandra Industrial Area, Anekal Taluk, Bengaluru
Bangalore
KARNATAKA
560099
India |
| Phone |
9068461064 |
| Fax |
|
| Email |
vanshikakarnwal2002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Basavaraj GS |
| Designation |
Senior Consultant – Endocrinology |
| Affiliation |
Narayana Health |
| Address |
Department of Diabetes and Endocrinology (basement), Narayana Institute of Cardiac Sciences ,No. 258/A, Bommasandra Industrial Area, Anekal Taluk, Bengaluru
Bangalore
KARNATAKA
560099
India |
| Phone |
9816038562 |
| Fax |
|
| Email |
basavaraj.gs.dr@narayanahealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikneswaran G |
| Designation |
Associate Consultant, Department of Clinical Research |
| Affiliation |
Narayana Health |
| Address |
Department of clinical research (basement), Narayana Institute of Cardiac Sciences ,No. 258/A, Bommasandra Industrial Area, Anekal Taluk,Bengaluru
Bangalore
KARNATAKA
560099
India |
| Phone |
9787649182 |
| Fax |
|
| Email |
vikneswaran.g.dr@narayanahealth.org |
|
|
Source of Monetary or Material Support
|
| Narayana Institute of Cardiac Sciences, No. 258/A, Bommasandra Industrial Area, Anekal Taluk Bengaluru, Karnataka (560099), India |
|
|
Primary Sponsor
|
| Name |
VANSHIKA KARNWAL |
| Address |
Department of clinical research (basement), Narayana Institute of Cardiac Sciences, No. 258/A, Bommasandra Industrial Area, Anekal Taluk Bengaluru |
| 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 Vikneswaran G |
Narayana Institute of Cardiac Sciences |
Department of clinical research (basement), Narayana Institute of Cardiac Sciences ,No. 258/A, Bommasandra Industrial Area, Anekal Taluk Bengaluru
Bangalore
KARNATAKA |
9787649182
vikneswaran.g.dr@narayanahealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Health Academics Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adults undergoing CTCA;
Either sex
|
|
| ExclusionCriteria |
| Details |
Patients not willing to provide written consent;
Patients with any other data that may affect body fat (pregnancy, congestive heart failure- NYHA class IV, known active malignancy, known CKD stage 5, Child Pugh-C, known hepatitis, HIV, ART exposure)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the correlation between epicardial adipose tissue and metabolic parameters in patients undergoing CT angiogram. |
Single time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NILL |
NILL |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
Final Enrollment numbers achieved (Total)= "165"
Final Enrollment numbers achieved (India)="165" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/12/2024 |
| Date of Study Completion (India) |
27/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 is a cross-sectional study to evaluate the
correlation between epicardial adipose tissue with the metabolic profile of
patients (n=165) undergoing CT-angiogram. CT-based EAT volume of
each patient will be measured using the semiautomated software. Information
regarding demographic variables, such as age, gender and clinically related
variables will be collected after informed consent is taken from study
participants. The correlation between
epicardial adipose tissue volume and metabolic parameters (BMI, lipid profile)
will be analysed using the statistical tests, Pearson/ Spearman correlation
test. |