| 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
|
|
|
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
|
|
|
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. |