| CTRI Number |
CTRI/2019/07/020471 [Registered on: 31/07/2019] Trial Registered Prospectively |
| Last Modified On: |
30/07/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Non Interventional |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Heart Disease Risk Score |
|
Scientific Title of Study
|
A Multicentre Prospective Observational Study on Cardiovascular Risk Factors to build a Standardized Predictive Risk Score for Indian Population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CVDRS 1 |
Protocol Number |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shiv Kumar J |
| Designation |
Sr Consultant Cardiology |
| Affiliation |
Apollo Hospitals |
| Address |
Department of Cardiology
72 Opp Bharatiya Vidya Bhavan
Jubilee Hills
Film Nagar Hyderabad
Hyderabad
TELANGANA
500033
India |
| Phone |
9989914440 |
| Fax |
|
| Email |
shivkumar2k5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shiv Kumar J |
| Designation |
Sr Consultant Cardiology |
| Affiliation |
Apollo Hospitals |
| Address |
Department of Cardiology
72 Opp Bharatiya Vidya Bhavan
Jubilee Hills
Film Nagar Hyderabad
Hyderabad
TELANGANA
500033
India |
| Phone |
9989914440 |
| Fax |
|
| Email |
shivkumar2k5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujoy Kar |
| Designation |
Chief Medical Information Officer |
| Affiliation |
Apollo Hospitals |
| Address |
Medical Informatics Department
72 Opp Bharatiya Vidya Bhavan
Jubilee Hills
Film Nagar Hyderabad
Hyderabad
TELANGANA
500033
India |
| Phone |
9831840587 |
| Fax |
|
| Email |
drsujoy_k@apollohospitals.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Apollo Hospitals |
| Address |
Road No 72 Opp Bharatiya Vidya Bhavan School
Jubilee Hills Film Nagar
Hyderabad |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Microsoft India |
Gachibowli, Hyderabad |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Ramakrishnan |
All India Institute of Medical Sciences |
Department of Cardiology
Ansari Nagar New Delhi 110029
New Delhi
DELHI |
9818186179
ramaaiims@gmail.com |
| Dr Bikas Mazumdar |
Apollo Gleneagles Hospitals |
Department of Cardiology
58 Canal Circular Road
Kolkata 700054
Kolkata
WEST BENGAL |
9903078488
bikashmaj@hotmail.com |
| Dr Girish N |
Apollo Hospitals |
Department of Cardiology
154 11 Bannerghatta Road
Opp I I M
Bangalore 560076
Bangalore
KARNATAKA |
08026304050
drgirish_n@apollohospitals.com |
| Dr J Shiv Kumar |
Apollo Hospitals |
Road No 72 Department of Cardiology
Opp Bharatiya Vidya Bhavan School
Jubilee Hills Film Nagar Hyderabad
Telangana 500033
Hyderabad
TELANGANA |
9989914440
shivkumar2k5@gmail.com |
| Dr Rahul Gupta |
Apollo Hospitals |
Department of Cardiology
Parsik Hill Road
Sector 23 CBD Belapur
Navi Mumbai 400 614
Mumbai
MAHARASHTRA |
02233503350
drrahul_g@apollohospitals.com |
| Dr Sameer Dani |
Apollo Hospitals |
Department of Cardiology
Plot No 1A
Bhat GIDC Estate Dist
Gandhinagar 382428
Ahmedabad
Gujarat
Gandhinagar
GUJARAT |
9825038855
drsameerdani@gmail.com |
| Dr Y Vijaya Chandra Reddy |
Apollo Hospitals |
Department of Cardiology
21 Greams Road Off Greams Lane
Chennai
Chennai
TAMIL NADU |
044-28295465
drvijayachandra_r@apollohospitals.com |
| Dr N N Khanna |
Indraprastha Apollo Hospitals |
Department of Cardiology
Sarita Vihar
Delhi Mathura Road
New Delhi 110076
New Delhi
DELHI |
9810494072
drnnkhanna@gmail.com |
| Dr Rishi Sethi |
King George Medical University |
Department of Cardiology
Shah Mina Rd Chowk
Lucknow
Uttar Pradesh 226003
Lucknow
UTTAR PRADESH |
9838571770
drrishisethi1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee-Clinical Studies |
Approved |
| Institutional Ethics Committee-Clinical Studies |
Approved |
| Institutional Ethics Committee-Clinical Studies |
Approved |
| Institutional Ethics Committee-Clinical Studies |
Approved |
| Institutional Ethics Committee-Clinical Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I999||Unspecified disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
79.00 Year(s) |
| Gender |
Both |
| Details |
Subject presenting for Routine Health Check (Asymptomatic)
Subject presenting with Cardiovascular Respiratory General Weakness Abnormal Lab Values or Imaging Tests (Symptomatic)
Subject willing to provide informed consent and comply with study procedure |
|
| ExclusionCriteria |
| Details |
Life Threatening Conditions
Altered physiological criteria (Triage 1 & 2 of Canadian Triage Acuity Scale)
Respiratory Distress (moderate to severe)
Trauma
Pregnancy or post-partum period
Circulatory shock
Coma
Altered LOC
Fever – Sepsis or immuno-compromised patients and
Any form of Poisoning
Previously treated Coronary Artery Disease with revascularization (PTCA/CABG) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determining number of cardiovascular events in enrolled subjects who are detected to have high or moderate risks |
5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determine the variation of risk score of a subject over a period of time based on recommended risk reduction strategies and medical intervention |
5 years |
|
|
Target Sample Size
|
Total Sample Size="6100"
Sample Size from India="6100"
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)
|
30/08/2019 |
| 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="6"
Months="10"
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)?
|
|
Brief Summary
|
A Prospective Observational Non-Interventional Study to build a standardized predictive risk score for Indian Population on Cardiovascular risk factors. This is an application program interface which aids in entry of patient’s data related to Cardiovascular risk and predicts the personalized risk score. Total 6100 patients will be included in this study from multiple sites across India. Data elements collected from routinely recorded information in the electronic medical record.Specific laboratory tests or procedures that are mandated as a part of subjects clinical condition are at the discretion of the site investigator under standard practice.
|