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CTRI Number  CTRI/2025/07/090953 [Registered on: 15/07/2025] Trial Registered Prospectively
Last Modified On: 03/02/2026
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 Heart Disease Risk among Indian individuals at risk Through Assessment of Coronary Artery Calcium Score 
Scientific Title of Study   Coronary Artery Calcium Scoring in Asymptomatic Indian population: Correlation with ASCVD risk scores, Age, Gender and other risk factors. 
Trial Acronym  CASCADE 
Secondary IDs if Any  
Secondary ID  Identifier 
SP/CVD/CASCADE/01-2025 Version 1.0 dated 17 Mar 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chintan Khandhedia 
Designation  Team 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
MAHARASHTRA
400063
India 
Phone  02243244324  
Fax    
Email  Chintan.Khandhedia@sunpharma.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neeraj Markandeywar 
Designation  General Manager - Medical Affairs and Clinical Research 
Affiliation  Sun Pharma Laboratories Limited 
Address  Sun Pharma Laboratories Limited, Plot No. 201, B/1, Western Express Highway, Goregaon (E)

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
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 Limited 
Address  Plot No. 201, B/1, Western Express Highway, Goregaon (E), Mumbai-400063 Maharashtra INDIA 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr C G Bahuleyan  Ananthapuri Hospital and Research Centre  Ananthapuri Hospitals and Research Institute, 31/1424, Thiruvananthapuram, Kerala, 695 024
Thiruvananthapuram
KERALA 
9447344882

bahuleyan2001@yahoo.co.uk 
Dr Neil Bardoloi  Apollo Excelcare Hospital  Paschim Boragaon, Near Ganesh Mandir, NH 37, Guwahati, Dist-Kamrup Metropolitan, Assam-781033, India
Kamrup
ASSAM 
9435703742

neilbard@rediffmail.com 
Dr Manoj Chopada  Chopda Medicare and Research Centre Pvt. Ltd. Magnum Heart Institute  3/5, Patil Lane No.1, Laxmi Nagar, Near K.B.H. Vidyalaya, Canada Corner, Nashik- 422005, Maharashtra
Nashik
MAHARASHTRA 
9823021613

drchopdamanoj@gmail.com 
Dr Jabir Abdullakutty  Lisie Hospital  Lisie Hospital P. B. No 3053, Kochi, Kerala-682018, India
Ernakulam
KERALA 
9447011773

drjabi@yahoo.co.in 
Dr Nirav Shah  Medilink Hospital Research Centre  Near Shyamal Cross Road, 132’ft. Ring Road, Satellite, Ahmedabad-380015.Gujarat, India
Ahmadabad
GUJARAT 
9408876400

snirav33@gmail.com 
Dr Krishna Mala Konda Reddy  Osmania General Hospital  Begum Bazar, Afzalgunj, Hyderabad - 500012
Hyderabad
TELANGANA 
9848015098

drkmkreddy@yahoo.com 
Dr Pankaj Harkut  Swasthyam Superspeciality Hospital  97/98, Wardha Rd, Near Sai Mandir, Vivekanand Nagar, Nagpur, Maharashtra 440015
Nagpur
MAHARASHTRA 
9372723376

pankajharkut@rediffmail.com 
Dr Ajit Mullasari  The Madras Medical Mission Hospital  4-A, Dr. JJ Nagar, Mogappair-Chennai,600037, Tamil Nadu, India.
Chennai
TAMIL NADU 
9841271362

icvddoctors@mmm.org.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Institutional Ethics Committee - Ananthapuri Hospitals and Research Institute  Approved 
Institutional Ethics Committee - Excelcare Hospitals  Approved 
Institutional Ethics Committee - Lisie Hospital  Approved 
Institutional Ethics Committee - Osmania Medical College  Approved 
Institutional Ethics Committee - The Madras Medical Mission  Approved 
Magna Care Ethics Committee - Chopda Medicare and Research Centre  Approved 
Medilink Ethics Committee - Medilink Hospital Research Centre  Submittted/Under Review 
Swasthyam Ethics Committee - Swasthyam Superspeciality Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I70-I79||Diseases of arteries, arterioles and capillaries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Male of age between 40 to 65 years (both inclusive) or non-pregnant/non-lactating female of age between 40 to 70 years (both inclusive).
Participant with history or evidence of at least one of ASCVD risk factors such as hypertension (BP greater than or equal to 140/90 mmHg), diabetes mellitus (random plasma glucose greater than or equal to 200 mg/dl or fasting plasma glucose greater than or equal to 126 mg/dl or HbA1c greater than or equal to 6.5 percent), dyslipidemia (Cholesterol greater than or equal to 200 mg/dl or LDL-C greater than or equal to 130 mg/dl or HDL-C less than 40 mg/dl in men and less than 50 mg/dl in women or triglyceride greater than or equal to 150 mg/dl), a family history of premature CAD (having a primary relative who had been diagnosed with CAD prior to the age of 55 years in a male relative or 65 years in a female relative), or cigarette smoking (greater than or equal to 20 pack-years).
Participant willing to provide informed consent and comply with study procedures. 
 
ExclusionCriteria 
Details  Participant with CAD symptoms (chest discomfort, dyspnoea, palpitations, syncope or fatigue).
Participant with previous coronary revascularization i.e. CABG and/or angioplasty.
Participant with previous imaging (Angiography, CT angiogram, MR angiogram) showing CAD.
Participant with history of positive stress test. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Correlation between Coronary Artery Calcium score and 10-year Atherosclerotic Cardiovascular Disease risk score in Indian individuals asymptomatic for Coronary Artery Disease  Visit 1 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation between Coronary Artery Calcium score and Lipoprotein (a) Lp(a) values, high-sensitivity C-reactive protein (hsCRP), Urine albumin to creatinine ratio (ACR), estimated glomerular filtration rate (eGFR) and ultrasound sonography carotid plaques.  Visit 1 
Correlation between 10-year Atherosclerotic Cardiovascular Disease risk score and Lipoprotein (a) values, high-sensitivity C-Reactive Protein, Urine albumin to creatinine ratio (ACR), estimated glomerular filtration rate (eGFR), ultrasound sonography carotid plaques.  Visit 1 
Net reclassification of patients with 10-year Atherosclerotic Cardiovascular Disease risk score between 5 to 10 depending upon Coronary Artery Calcium score and ultrasound sonography carotid plaques.  Visit 1 
Atherosclerotic Cardiovascular Disease risk assessment on the basis of polygenic risk scores.  Visit 1 
Effect of different risk factors such as age, hypertension, diabetes mellitus, dyslipidemia, family history of premature Coronary Artery Disease and cigarette smoking on Coronary Artery Calcium score.  Visit 1 
Drug utilization pattern in the study participants.  Visit 1 
 
Target Sample Size   Total Sample Size="404"
Sample Size from India="404" 
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)   15/07/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Cardiovascular Diseases (ischemic heart disease and cerebrovascular disease conditions), are the leading cause of death worldwide. Atherosclerosis plays a central role, with early fatty streaks progressing to late complex atheromas. Vascular calcification has been shown to strongly correlate with degree of atherosclerosis.

Over the last several decades, the global prevalence and mortality of atherosclerotic cardiovascular disease (ASCVD) has increased. Identifying risk factors associated with ASCVD have been paramount to informing public health policies and interventions to reduce ASCVD risk. Assessing ASCVD risk based on CVD risk factors, including hypercholesterolemia, hypertension, tobacco use, and physical inactivity helps guide treatment, primarily aimed at reducing low-density lipoprotein-cholesterol (LDL-C) in primary prevention, as cumulative exposure to LDL-C is the main driver for ASCVD.

The ASCVD risk score, developed by the American College of Cardiology, is a calculation of person’s 10-year risk of developing a cardiovascular event, such as a heart attack or stroke. This risk estimate considers age, gender, race, cholesterol levels, blood pressure, medication use, diabetic status, and smoking status. However, ASCVD risk score is not validated for Indian population.

Coronary Artery Calcium (CAC) scoring has emerged as a widely available tool for stratifying cardiovascular risk, predicting patient outcomes, and guiding therapy. CAC is a highly specific marker for coronary atherosclerosis.

For the cardiovascular risk identification, different markers and clinical investigations are available. In this study, the participant will be stratified into different cardiovascular risk category based on different clinical risk estimation parameters and methods.  Overall, this study will help in identifying ASCVD risk levels of the individuals and correlate risk levels in appropriate cardiac risk category who are asymptomatic for coronary artery disease.

 
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