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CTRI Number  CTRI/2021/07/035263 [Registered on: 29/07/2021] Trial Registered Prospectively
Last Modified On: 18/02/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A study to understand the applicability of OPtimal Treatment of Angina (OPTA) questionnaire in patients with stable ischemic heart disease 
Scientific Title of Study   A study to understand the applicability of OPtimal Treatment of Angina (OPTA) questionnaire in patients with stable ischemic heart disease in routine/real world clinical practice in India. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
EPID-I21-0068  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Sneha Nair 
Designation  Head Clinical Operations  
Affiliation  Abbott Healthcare Private Limited 
Address  Floor 17-18 Godrej BKC Plot No C 68 BKC Near MCA Club, Bandra (E) Mumbai

Mumbai
MAHARASHTRA
6000119
India 
Phone  9970780488  
Fax    
Email  sneha.nair@abbott.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Karan Kumar Jejoe 
Designation  Director Medical Affairs 
Affiliation  Abbott Healthcare Private Limited 
Address  Floor 17-18 Godrej BKC Plot No C 68 BKC Near MCA Club, Bandra (E) Mumbai

Mumbai
MAHARASHTRA
400051
India 
Phone  7045011810  
Fax    
Email  jejoe.karankumar@abbott.com  
 
Details of Contact Person
Public Query  
Name  Dr Shivani Acharya 
Designation  Associate Director Clinical Development & Operation 
Affiliation  Abbott Healthcare Private Limited 
Address  Floor 17-18 Godrej BKC Plot No C 68 BKC Near MCA Club, Bandra (E) Mumbai Chennai

Mumbai
MAHARASHTRA
600119
India 
Phone  8657552543  
Fax    
Email  shivani.acharya@abbott.com  
 
Source of Monetary or Material Support  
Abbott Healthcare Pvt Ltd 
 
Primary Sponsor  
Name  Abbott Healthcare Pvt Ltd 
Address  Abbott Healthcare Private Limited 17-18 Floor Godrej BKC Plot C-68 G block Bandra Kurla Complex Near MCA Club Bandra (E) Mumbai Mumbai MAHARASHTRA 400051 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 = 43  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Swapnil Pathak  Aadya Cardiac Care  LGF, 21-26 Nishith plaza, Engineering college chauraha, Jankipuram, Lucknow-226021
Lucknow
UTTAR PRADESH 		 7234020983

drswapnil.sjh@gmail.com 
Dr Pritesh Punjabi  ACE Heart Clinic  Green Lawns CHS, Row House-4, Layout Rd, Shri Punit Nagar, Borivali West, Mumbai, Maharashtra-400092
Mumbai
MAHARASHTRA 		 9819472757

priteshpunjabi@gmail.com 
Dr Amit Soni  Arrow Diagnostic Lab & Heart Care Center  Shop No:95, phase 9 Mohali, Punjab, 160062
Rupnagar
PUNJAB 		 9815118149

mailtoamitsoni@yahoo.com 
Dr Balaji  Balaji Heart Center  SVL Towers, Ground floor, Opp. Anu Furniture, Beside Vodafone store, Near Police Station, Chanda Nagar, Hyderabad-500030
Hyderabad
TELANGANA 		 9848098307

drrbalaji@yahoo.co.in 
Dr Suraj Kulkarni  Bhagawani Mahaveer Jain Hospital  No 17 , First floor Department of cardiology Bhagawani Mahaveer Jain Hospital Millers road Vasanthnagar, Bangalore
Bangalore
KARNATAKA 		 9591574496

surajkk3105@gmail.com 
Dr Ashootosh Bhardwaj  Bhardwaj Heart Care  S.C.O.365, Sector 32D, Chandigarh-160030
Chandigarh
CHANDIGARH 		 9855502624

dr.ashootosh81@gmail.com 
Dr Peyush Khera  Cardiac Care Clinic  PremisisNo:20,Gurudwara Naka Hindola Complex,Vijay nagar, Charbagh, Lucknow-226004
Lucknow
UTTAR PRADESH 		 9839010385

drpeyushkhera@yahoo.com 
Dr Amit Chaudhary  Care Clinic  KBC-27, Opp. Phoenix Mall, Sector B, Bargawan, LDA Colony, Lucknow-226012
Lucknow
UTTAR PRADESH 		 8840873626

docamit1914@gmail.com 
Dr Anil Jawahirani  Central India Cardiology Hospital & Research Institute  Ring Road, Kapil Nagar, Pane Layout, Vivekanand Nagar, Nagpur-440015
Nagpur
MAHARASHTRA 		 9822220936

anilramesh123@rediffmail.com 
Dr Satrajit Samanta  Dr. Satrajit Samanta Clinic  16 J.K Street (Near power House), 62/2, Netaji Subhas Rd, Hindmotor, Bally, Uttarpara-712232, West Bengal
Kolkata
WEST BENGAL 		 8583000269

satrajitsamanta@yahoo.co.in 
DrJayesh Prajapati  Dr.Jayesh Prajapatis Clinic  #603, Bodycare Building, Behind Juna Vadaj Bus stand, Ashram Road, Ahmadabad-380013
Ahmadabad
GUJARAT 		 9825022996

drjsprajapati@yahoo.co.in 
Dr Nazir Juvale  Dr.Juvales Heart Clinic  Apartment 1st floor, 104 Zia, 264, Bellasis Rd, next to Anjuman girl’s school, Mumbai, Maharashtra-400008
Mumbai
MAHARASHTRA 		 9322519715

drjuvalenazir@gmail.com 
Dr Nitin Patki  Dr.Nitin S Patki Clinic  #203, Fortune 1206 A/13,Shirole Road, Above Telephone Shoppees, Shivaji nagar, Pune-411004
Pune
MAHARASHTRA 		 9822041699

nitinspatki@gmail.com 
Dr Joyal Shah  Epic Hospital  Empire Doctor House, Beside Amiraj Farms, Sarkhej - Gandhinagar Hwy, Opp. Kargil Petrol Pump, Sola, Ahmadabad, Gujarat-380060
Ahmadabad
GUJARAT 		 9825319645

drjoyal@gmail.com 
Dr Deepak Nandhan  Ganges Clinic  Chermukku Temple Road, Chembukkavu, Thrissur-680020
Thrissur
KERALA 		 9446024950

drdnclt@gmail.com 
Dr Kumar Rajeev  H2H Cardiac Center  Shop No.C2,Shah Complex 2,plot no 3,near union bank,opposite guru mahima heights,palm beach road,sector 13,sanpada,navi mumbai, maharashtra-400705
Mumbai
MAHARASHTRA 		 9322596091

doc_rajeev@rediffmail.com 
Dr Bupesh R Shah  Harshal Cardiovascular Clinic  Clinic: 14, Palm Spring, Kalupur Bank Lane, Parimal Garden, Ellisbridge, Ahmadabad-380006
Ahmadabad
GUJARAT 		 9825032373

shahbhupesh@hotmail.com 
Dr Harshit Gupta  Heart Clinic  Hanuman Bhawan I, J.N. Sanyal road, Shivaji Marg, Kamta, Lucknow-226018
Lucknow
UTTAR PRADESH 		 8968048336

hg2111@gmail.com 
Dr Bishwa Bhushan Bharti  Heart Cure  A-191, P.C Colony, Road no.2, West side of Faneshwr Nath Renu Park,Patna-80020
Patna
BIHAR 		 9431020393

bbbharati_dr@rediffmail.com 
Dr Jayapal  Hridayalaya Preventive Cardiology Centre  Deepam pettah, Thiruvanthapuram, Kerala-695024
Thiruvananthapuram
KERALA 		 9447210112

jeyapalv57@gmail.com 
Dr Krishna Dhoot  Hruday Sparsh Heart Care Centre  #203, 2nd floor, Aryan Center, Opp. Vaibhav theater, Hadapsar, Pune-411028
Pune
MAHARASHTRA 		 9422423414

krishnadr2@rediffmail.com 
Dr Soumya Ranjan Mahapatra  IMS & Sum Hospital  K8, Lane 1, Kalinganagar, Bhubaneswar, Odisha-751003
Cuttack
ORISSA 		 9654068249

drsrmahapatra@gmail.com 
Dr Abhijit Joshi  Joshi Polyclinic & Heart Care Centre  #7, chinar heights, 2nd Floor, Deep Bungalow Chowk, Above canara bank-general branch, model colony, Pune-411016
Pune
MAHARASHTRA 		 9823074846

abhibhaskar100@rediffmail.com 
Dr Sandeep Fulpagare  JUI Clinic  19, Cosmos Tower, LBS Marg, Near Majiwada Flyover, Opp. PARAM Hospital, Thane(W), Maharashtra 400601.
Thane
MAHARASHTRA 		 9022096660

fsandip@gmail.com 
Dr Mohana Murugan  KM Hospitals  #64, Medavakkam Tank Road, Kilpauk, Chennai-600010
Chennai
TAMIL NADU 		 9444027188

psmmurugan@gmail.com 
Dr Jayagopal P B  Lakshmi Hospital  Door No 1 Department of cardiology Lakshmi Hospital Chittur road Palakkad Kerala
Palakkad
KERALA 		 9847023777

jaigopallakshmi@gmail.com 
Dr Ashish Kumar Jha  Magadh Mithila Cardiac Center  Under Bahadurpur Flyover, Kankarbagh, Patna - 800020
Patna
BIHAR 		 9159061002

dr.a.k.jha79@gmail.com 
Dr Sanket Saraiya  Nidaan Heart Clinic  #301, Krisil Tower, besides Iscon Heights, Nr. Yah Complex, Gotri Road, Vadodara-390021
Vadodara
GUJARAT 		 9727715290

nidaanheartclinic@gmail.com 
Dr Amit Gupta  Olive Heart Care Centre  Bungalow# 120,Phase 381,Mohali, Punjab-160059
Rupnagar
PUNJAB 		 9876981059

docamitgupta@yahoo.co.in 
Dr Anup Singh  Patna Heart Clinic  Flat.no. 161, P.C. Colony Road, Kankarbagh, Patna-800020
Patna
BIHAR 		 8340362268

anupsinghmch@yahoo.com 
Dr Samiyappan Prabhu  PGS Hospital  #14, Cowly brown road, Opp. Central Theatre Road, R.S Puram, Coimbatore-641002
Coimbatore
TAMIL NADU 		 9443061115

shamprabu@yahoo.co.in 
Dr Abhishek Shukla  Pulse Heart Centre  Shop No-3,4,5, Royal Plaza Near Petrol Pump, Munshipuliya, Sector 16, Indira Nagar, Lucknow, Uttar Pradesh 226016
Lucknow
UTTAR PRADESH 		 8887987104

abhishekkshukla1984@gmail.com 
Dr Satbir Singh  Sacred Heart Health Care Clinics  J-9/17G,Ground Floor,Rajouri Garden, Delhi-110027
New Delhi
DELHI 		 9717456667

drsatbir9717456667@gmail.com 
Dr Keyur Patel  Shashwat Cardiac & Cancer Care  #301, OM Arcade, Opp. Green Elina, Anand Mahal Road, Adajan, Surat-395009
Surat
GUJARAT 		 9974708173

drkeyurpatel12586@gmail.com 
Dr Mahesh Chandulal Fulwani  Shri Krishna Hrudayalaya & Critical Care Center  Room no 5 Department of Cardiology Shri Krishna Hrudayalaya & Critical Care CenterTikekar road Congress Nagar square Dhantoli
Nagpur
MAHARASHTRA 		 9921120005

drmaheshfulwani@gmail.com 
Dr Binayananda Padhee  Shri Medscan  Plot no.420/2348, Padmawati Vihar, Damana Square, Chandrasekharpur, Bhubaneswar-751003
Cuttack
ORISSA 		 9438525696

binay_babu@yahoo.com 
Dr Kumar Kenchapa  Sparsh Super Speciality Hospital  No 146, Ground Floor Department of Cardiology, Sparsh Super Speciality Hospital Infanty road, opposite to commissioners office Bengaluru
Bangalore
KARNATAKA 		 8861499206

drkumarkenchappa@gmail.com 
Dr Thirumurugan  Sri Kumaran Hospital  No.774, P.N.Road, Near Bus Stand, tirupur, Tamilnadu-641602
Ramanathapuram
TAMIL NADU 		 9842292774

drthirumurugan358@gmail.com 
Dr Gururaj Pramod  SRI SRI Holistic Hospitals  1-2-49/13B, Nizampet Road, Hydernagar, Kukatpally, Hyderabad-500072
Hyderabad
TELANGANA 		 9908649700

drkgururaj@gmail.com 
Dr Naveen Krishna  Star Hospitals  B-2-596/5, Road No.10, Banjara hills, Hyderabad-500034
Hyderabad
TELANGANA 		 9492906333

drnaveenkrishna@gmail.com 
Dr Manabhanjan Jena  The Alma Super Speciality Clinics  D-15, Maitrivihar, Chandrasekharpur, In Front Of Tennis Court, Bhubaneshwar-751023
Cuttack
ORISSA 		 9437074054

jena.mana@gmail.com 
Dr Ashwani Mehta  The Heart Clinic  No-13, Double Storex Market, New Rajinder Nagar, New Delhi-110060
New Delhi
DELHI 		 9811057384

drashwanimehta@gmail.com 
Dr Vinodkumar Madan Vijan   Vijan Cardiac & Critical Care Centre  Dr.Vijan hospital Marg, HPT College road, Nashik, Maharashtra-422005
Nashik
MAHARASHTRA 		 9822025353

vmvijan@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 43  
Name of Committee  Approval Status 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I20-I25||Ischemic heart diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Male and female patients >18 years of age
2. Patients who have completed at least 10 years of school education
3. Patients with a confirmed history of stable ischemic heart disease documented in
their medical records and who are on medical therapy for at least the past 3 months. 
 
ExclusionCriteria 
Details  1. Patients with a history of coronary artery bypass grafting within the past 6 months
2. Patients with a history of ACS and/or percutaneous transluminal coronary
angioplasty (PTCA) within the past 6 months
3. Any patient found to be unsuitable by the investigator 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To understand the applicability of OPtimal Treatment of Angina (OPTA) questionnaire in patients with stable ischemic heart disease in routine/real world clinical practice in India.  Day-1 
 
Secondary Outcome  
Outcome  TimePoints 
To understand the applicability of OPtimal Treatment of Angina (OPTA) questionnaire in patients with stable ischemic heart   Day-1 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
Final Enrollment numbers achieved (Total)= "354"
Final Enrollment numbers achieved (India)="354" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  		 02/08/2021 
Date of Study Completion (India) 11/01/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 11/01/2022 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This will be a cross-sectional, single visit study. to understand the applicability of OPtimal treatment of angina (OPTA) questionnaire in patients with stable ischemic heart disease. The study will be conducted involving approximately 500 patients across 50 cardiologists in India.  Investigator/designee will obtain the patient authorization for participation in study.The study investigator will administer the following OPTA questionnaire in their established cases of stable ischemic heart disease patients. This information will be captured in the web-based platform or mobile application.

 
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