| CTRI Number |
CTRI/2023/09/057294 [Registered on: 06/09/2023] Trial Registered Prospectively |
| Last Modified On: |
08/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Prospective Study: Assessing Epicardial Adipose Tissue as a Risk Factor for Major Adverse Cardiovascular Events |
|
Scientific Title of Study
|
Evaluation of Role of Epicardial Adipose Tissue as a Risk Factor for Major
Adverse Cardiovascular Events – A Prospective Observational Study |
| Trial Acronym |
EAT STUDY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Basavaraj GS |
| Designation |
Consultant Diabetes and Endocrinology |
| Affiliation |
Narayana Institute of Cardiac Sciences |
| Address |
Narayana Institute of Cardiac Sciences,
258/A Bommasandra Industrial Area, Anekal Taluk, Bengaluru
Narayana Institute of Cardiac Sciences,
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
Scientific Query
|
| Name |
Dr Basavaraj GS |
| Designation |
Consultant Diabetes and Endocrinology |
| Affiliation |
Narayana Institute of Cardiac Sciences |
| Address |
Narayana Institute of Cardiac Sciences,
258/A Bommasandra Industrial Area, Anekal Taluk, Bengaluru
Narayana Institute of Cardiac Sciences,
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 Basavaraj GS |
| Designation |
Consultant Diabetes and Endocrinology |
| Affiliation |
Narayana Institute of Cardiac Sciences |
| Address |
Narayana Institute of Cardiac Sciences,
258/A Bommasandra Industrial Area, Anekal Taluk, Bengaluru
Narayana Institute of Cardiac Sciences,
258/A Bommasandra Industrial Area, Anekal Taluk, Bengaluru
Bangalore
KARNATAKA
560099
India |
| Phone |
9816038562 |
| Fax |
|
| Email |
basavaraj.gs.dr@narayanahealth.org |
|
|
Source of Monetary or Material Support
|
| Narayana Institute of Health sciences, 258/A, Hosur Road Anekal Taluk, Bommasandra Industrial Area, Bengaluru, Karnataka 560099 |
|
|
Primary Sponsor
|
| Name |
Dr Basavaraj GS |
| Address |
Narayana Institute of Cardiac Sciences, 258/A, Hosur Road Anekal Taluk, Bommasandra Industrial Area, Bengaluru, Karnataka |
| 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 |
| Dr Basavaraj GS |
Narayana institute of cardiac science |
258/A Bommasandra Industrial Area, Anekal Taluk, Bengaluru- 560099
Bangalore
KARNATAKA |
9816038562
basavaraj.gs.dr@narayanahealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Narayana health academic ethics committee |
Approved |
| narayana health academic ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I778||Other specified disorders of arteries and arterioles, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults (Age > 18 years) undergoing CTCA
2. Either sex
3. Consenting to participate
4. Willing for remote monitoring / follow up |
|
| ExclusionCriteria |
| Details |
Pregnancy
2. CHF – Stage D
3. Known active malignancy
4. Known CKD stage 5 or Child Pugh C
5. Known Hepatitis B / Hepatitis C
6. HIV and/or ART exposure
7. Endocrinological diseases which might affect the EAT – Cushing’s Syndrome, Acromegaly, Hyperparathyroidism, Pituitary pathologies on medications or hormone supplements, Addison’s disease,Graves’ disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.association between the EAT
volume determined by CT and MACE events reported in patients undergoing elective coronary angiogram |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
the correlation between patient’s volume of EAT and
prior Coronary artery disease (CAD) |
3 years |
|
|
Target Sample Size
|
Total Sample Size="1812"
Sample Size from India="1812"
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)
|
12/09/2023 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
Modification(s)
|
This prospective observational study in India
focuses on patients undergoing CT angiography as per the standard of
care will be screened and enrolled in the study after obtaining informed
consent. The study aims to delineate the influence of EAT volume measured by CT
in patients undergoing coronary angiogram and MACE events.
|