| CTRI Number |
CTRI/2024/02/062577 [Registered on: 13/02/2024] Trial Registered Prospectively |
| Last Modified On: |
05/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the cardiovascular disease risk in Indian patients |
|
Scientific Title of Study
|
Assessment of Atherosclerotic Cardiovascular Disease (ASCVD) Risk using ASCVD Risk Estimator Plus in Indian Patients – A Real-world, Retrospective Study from Electronic Medical Records (HEART-STRONG Study) |
| Trial Acronym |
HEART-STRONG |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SP/CVD/HEART-STRONG/RWE-24-2023 V1.0 dated 09Jan2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chintan Khandhedia |
| Designation |
Overall Trial Coordinator - Lead - Clinical Research | RWE |
| Affiliation |
Sun Pharma Laboratories Limited |
| Address |
Sun Pharma Laboratories Limited, Plot No. 201, B/1, Western Express Highway, Goregaon (E), Mumbai- 400063
Mumbai
MAHARASHTRA
400063
India
Mumbai
MAHARASHTRA
400063
India |
| Phone |
02243244324 |
| Fax |
|
| Email |
Chintan.Khandhedia@sunpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeraj Markandeywar |
| Designation |
Deputy General Manager - Medical Affairs |
| Affiliation |
Sun Pharma Laboratories Limited |
| Address |
Sun Pharma Laboratories Limited, Plot No. 201, B/1, Western Express Highway, Goregaon (E), Mumbai- 400063
Mumbai
MAHARASHTRA
400063
India
Mumbai
MAHARASHTRA
400063
India |
| Phone |
9022797378 |
| Fax |
|
| Email |
Neeraj.Markandeywar@sunpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Colette Pinto |
| Designation |
Manager - Clinical Research | RWE |
| Affiliation |
Sun Pharma Laboratories Limited |
| Address |
Sun Pharma Laboratories Limited, Plot No. 201, B/1, Western Express Highway, Goregaon (E), Mumbai- 400063
Mumbai
MAHARASHTRA
400063
India
Mumbai
MAHARASHTRA
400063
India |
| Phone |
02243244324 |
| Fax |
|
| Email |
Colette.Pinto@sunpharma.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharma Laboratories Ltd. Plot No. 201, B/1, Western Express Highway, Goregaon (E),Mumbai - 400063 Maharashtra INDIA |
|
|
Primary Sponsor
|
| Name |
Sun Pharma Laboratories Ltd. |
| Address |
Plot No 201, B1, Western Express Highway, Goregaon (E) Mumbai-400063 Maharashtra INDIA |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Neeraj Markandeywar |
HealthPlix Technologies |
2nd floor, AWFIS, Vajram Esteva New Survey No 57-4, Old Survey No 57-2, Marathahalli-Sarjapur Outer Ring Road Devarabisanahalli, Varthur
Outer Ring Rd, Bengaluru, Karnataka 560103
Bangalore
KARNATAKA |
9022797378
Neeraj.Markandeywar@sunpharma.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Royal Pune Independent 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 |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
79.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex between 20-79 years of age
Patients with SBP between 90-200 mmHg
Patients with DBP between 60-130 mmHg
Patients with TC between 130-320 mgdL
Patients with HDL cholesterol between 20-100 mgdL
Patients with data on the history of diabetes (Yes No)
Patients with data on smoking status (current former never)
Patients with data on hypertension treatment (Yes no)
Patients with LDL between 30-300 mgdL
Patients with data on statin therapy (Yes No)
Patients with data on aspirin therapy (Yes No) |
|
| ExclusionCriteria |
| Details |
Patients with current ASCVD and history of ASCVD (i.e. CHD, such as myocardial infarction, angina, and coronary artery stenosis; Cerebrovascular disease, such as a transient ischemic attack, ischemic stroke, and carotid artery stenosis; Peripheral artery disease, such as claudication; Aortic atherosclerotic disease, such as abdominal aortic aneurysm and descending thoracic aneurysm).
Patients with incomplete medical records with respect to the required study parameters |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean 10-year ASCVD risk using ASCVD risk estimator plus in study population |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean lifetime ASCVD risk using ASCVD risk estimator plus in study population |
Baseline |
| Mean optimal ASCVD risk using ASCVD risk estimator plus in the study population |
Baseline |
| Mean values of TC, LDL-C, HDL-C, SBP, & DBP in the total study population |
Baseline |
| Prevalence of comorbidities in the study population |
Baseline |
| Prevalence of smoking in the study population |
Baseline |
| Drug utilization pattern in the study population |
Baseline |
| Correlation of ASCVD Risk with patient’s age & gender, comorbidities, concomitant medications & ASCVD risk factors |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="4500"
Sample Size from India="4500"
Final Enrollment numbers achieved (Total)= "4114"
Final Enrollment numbers achieved (India)="4114" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/02/2024 |
| Date of Study Completion (India) |
03/06/2025 |
| 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)
|
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 retrospective, observational, cross-sectional, real-world evidence study from Electronic Medical records to assess cardiovascular disease risk in Indian patients. Currently, limited real-world data is available in India on risk levels assessed by ASCVD Estimator Plus. This study aims to assess the ASCVD risk of Individuals from the EMR for whom the data required to assess ASCVD risk is available. |