CTRI

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CTRI Number

CTRI/2024/02/062809 [Registered on: 19/02/2024] Trial Registered Prospectively

Last Modified On:

21/03/2025

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Regsitry

Study Design

Single Arm Study

Public Title of Study

Heart Main Vessel Angioplasty Study

Scientific Title of Study

A Prospective Multicenter Indian LMCA Registry

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
LMCA-01	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Prathap Kumar N
Designation	Director
Affiliation	Interventional Cardiology Research and Training Foundation
Address	Department of Interventional Cardiology 31/2487/86 Near Meditrina Hospitals Ayathil P.O Kollam Kerala Kollam KERALA 691021 India
Phone	04742721111
Fax
Email	prathapndr@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Prathap Kumar N
Designation	Director
Affiliation	Interventional Cardiology Research and Training Foundation
Address	Department of Interventional Cardiology 31/2487/86 Near Meditrina Hospitals Ayathil P.O Kollam Kerala Kollam KERALA 691021 India
Phone	04742721111
Fax
Email	prathapndr@gmail.com

Details of Contact Person
Public Query

Name	Dr Prathap Kumar N
Designation	Director
Affiliation	Interventional Cardiology Research and Training Foundation
Address	Department of Interventional Cardiology 31/2487/86 Near Meditrina Hospitals Ayathil P.O Kollam Kerala Kollam KERALA 691021 India
Phone	04742721111
Fax
Email	prathapndr@gmail.com

Source of Monetary or Material Support

Interventional Cardiology Research And Training Foundation 31/2487/86 Near Meditrina Hospitals Ayathil P.O Kollam Kerala

Primary Sponsor

Name	Interventional Cardiology Research And Training Foundation
Address	31/2487/86, Near Meditrina Hospitals, Ayathil, P.O, Kollam, 691021, Kerala
Type of Sponsor	Research institution

Details of Secondary Sponsor

Name	Address
Nil	NA

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 51
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Gopala Krishna Koduru	Aayush NRI LEPL Healthcare Private Limited	Dept of Cardiology Aayush NRI LEPL Healthcare Pvt. Ltd., 48-13-3&3A, Sri Ramachandra Nagar Vijayawada Krishna ANDHRA PRADESH	9849110541 gopalkoduru@gmail.com
Dr Rajeev Menon	AIG Hospitals	Department of Cardiology, Survey No. 136, Plot No. 2/3/4/5,1, Mindspace Road, Gachibowli, Hyderabad, Telangana-500032 Hyderabad TELANGANA	9959622556 rmenon73@gmail.com
Dr Rajesh Thachathodiyl	Amrita Institute of Medical Sciences	Dept of Cardiology AIMS Ponekkara P.O Kochi Ernakulam KERALA	9895028709 rajesht67@gmail.com
Dr Bahuleyan Charantharalyil Gopalan	Ananthapuri Hospitals and Research Institute	Department of Interventional Cardiology, AHRI, Chacka, Thiruvanathauram, Kerala,695024, India Thiruvananthapuram KERALA	9447344882 bahuleyan2001@yahoo.co.uk
Dr A Sreenivas Kumar	Apollo Hospitals	Department of Cardiology, Apollo Hospitals, Jubilee Hills, Hyderabad-500096, Telangana, India Hyderabad TELANGANA	98480 46785 arramraj@yahoo.com
Dr Girish B Navasundi	Apollo Hospitals	Department of Cardiology, 154/11, Opp I.I.M Bannerghatta Road, Bangalore-560076 Bangalore KARNATAKA	9866000529 navasundi@rediffmail.com
Dr Lakshmikanth P	Apollo Hospitals	Department of Cardiology, 154/11, Opp I.I.M Bannerghatta Road, Bangalore-560076 Bangalore KARNATAKA	9742306268 drlakshmikanthp@yahoo.in
Dr PK Sahoo	Apollo Hospitals	Department of Cardiology, Plot No. 251, Sainik School Road, Unit-15, Bhubaneswar-751005, Odisha, India Khordha ORISSA	8093060049 drprasant_s@apollohospitals.com
Dr Refai S	Apollo Hospitals	Department of Cardiology, Greams Lane, Off Greams Road, Thousand Lights, Chennai 600 006 Tamil Nadu Chennai TAMIL NADU	9566092233 refais@gmail.com
Dr Sameer Dani	Apollo Hospitals	Apollo CVHF Heart Institute, Next to I.O.C, Petrol Pump, Opp. GNFC info tower, Pakwan Cross Road, Sarkhej- Gandhinagar Highway, Bodakdev, Ahmedabad, Gujarat 380059 Ahmadabad GUJARAT	9825038855 drsameerdani@gmail.com
Dr Sarita Rao	Apollo Hospitals	Deparment of Cardiology, Sector-D, Scheme No 74C, Vijay Nagar, Indore, Madhya Pradesh, 452010 Indore MADHYA PRADESH	8247219324 saritarosh@yahoo.com
Dr Aftab Khan	Apollo Multispeciality Hospital	Cath Lab, 58, Canal Circular Road, Kolkata, 700054 Kolkata WEST BENGAL	9831257844 cardiokhan@gmail.com
Dr Abhijit Vilas Kulkarni	Apollo Speciality Hospitals	Department of Cardiology, Jayanagar, Vaishnavi terraces, Dollars Colony, Phase-4, JP Nagar, Bangalore - 560078 Bangalore KARNATAKA	9008022866 abhijitvilaskulkarni@yahoo.com
Dr Anand Gnanaraj	Apollo Speciality Hospitals	Department of Cardiology, No. 64, Off P. H. Road, Ayanambakkam, Chennai- 600095 Chennai TAMIL NADU	9840228351 gnanaraj.anand@gmail.com
Dr Placid Sebastian	Aster MIMS Hospital	Department of Cardiology, Aster MIMS Kannur, Chala East, Chala, Kannur, Kerala, 670621 Kannur KERALA	9495161301 placidseb@gmail.com
Dr Ravi Cherian Mathew	Believers Church Medical College Hospital	Department of OPD, St. Thomas Nagar, Kuttapuzha, Thiruvalla, Kerala,689103 Pathanamthitta KERALA	944770238 drravicmathew@gmail.com
Dr Deepak Davidson	Caritas Hospital Institute of Health Sciences	Depart of Interventional Cardiology Thellakom P.O Kottayam Kottayam KERALA	9447216959 deepakdavidson@yahoo.com
Dr Sanjeeb Roy	CK Birla Hospitals	Depart of Cardiology, Rukmani Birla Hospital, A unit of Calcutta Medical Research Institute, Gopalpura Bypass Road, Near Triveni Flyover, Shanthi Nagar, Gopalpura Mode, Jaipur, Rajasthan 302018 Jaipur RAJASTHAN	9829644459 roysanjeeb@gmail.com
Dr P K Asokan	Fathima Hospital	Fathima Hospital, Bank Rd, Near LIC Office, Kozhikode, Kerala 673001 Kozhikode KERALA	98470 05074 asokanu@yahoo.co.in
Dr Gopi Aniyathodiyil	Fortis Hospitals	Department of Cardiology, Fortis Hospitals Limited, 14 Cunningham Road Bangalore, 560052, Karnataka, India Bangalore KARNATAKA	98450 47728 gopi.a.dr@gmail.com
Dr Keshava Ramaiah	Fortis Hospitals	Cath Lab, 14 Cunningham Road Bangalore, 560052, Karnataka, India Bangalore KARNATAKA	9845033681 rkeshava@hotmail.com
Dr Sanjeev Gera	Fortis Hospitals	Cath Lab, B-22, Rasoolpur Nawada, D Block, Sector 62, Noida, Uttar Pradesh Gautam Buddha Nagar UTTAR PRADESH	98104 66173 sanjeevgera293@gmail.com
Dr Shuvanan Ray	Fortis Hospitals	Department of Cardiology, 730, Anandapur, EM Bypass Road, Kolkata,700107, West Bengal. Kolkata WEST BENGAL	9830024266 shuvananray@gmail.com
Dr Rajpal K Abhaichand	G. Kuppuswamy Naidu Memorial Hospital,	Department of Cardiology, P.B. No. 6327, Netaji Road, Pappanaickenpalayam, Coimbatore-641037, India Coimbatore TAMIL NADU	0 abhai.cardio@gmail.com
Dr Anand Rao	Holy Family Hospital	Department of OPD, St Andrews Rd, Bandra West, Mumbai, Maharashtra 400050 Mumbai MAHARASHTRA	9821423464 andkina@yahoo.co.in
Dr Sandeep Parekh	Indus International Hospital	Department of OPD Chandigarh-Ambala Road, NH-22, Derabassi, SAS Nagar, Punjab 140507 Mansa PUNJAB	7675076611 sandeep.parekh81@gmail.com
Dr Shishir Roul	Jagjivanram Hospital	Cath Lab, Western Railway, Near Maratha Mandir Mumbai MAHARASHTRA	9004490572 drshishirroul@gmail.com
Dr Ajit Bhagwat	Kamalnayan Bajaj Hospital	Cath Lab, Kamalnayan Bajaj Hospital, Gut no. 43, Satara Parisar, Beed bypass road, Aurangabad - 431010 Aurangabad MAHARASHTRA	9822050817 drajitbhagwat@gmail.com
Dr Ramesh Natarajan	KIMS Healthcare	Kumarapuram Poonthi Road, Anamukham PB, Anayara PO, Trivandrum- 695029 Thiruvananthapuram KERALA	9394329698 natarajanramesh79@gmail.com
Dr Sajan Narayanan	Little flower Hospital & Research Institute	Department of Cardiology, Little Flower Hospital & Research Centre Angamaly - 683572 Ernakulam KERALA	8086842627 sajannarayanan@gmail.com
Dr CB Keshavamurthy	Manipal Hospital	Depart of Cardiology, #85-86, Mysuru-Bangalore Ring Road Junction, Bannimantap â€˜Aâ€™ Layout, Siddiqui Nagar, Mysuru 570015 Mysore KARNATAKA	9900152852 cbkeshavamurthy@gmail.com
Dr Karthik Vasudevan	Manipal Hospital	Depart of Cardiology, Manipal Hospitals, Yeshwatpur, Brigade Gateway, #26/4,80feetRoad, Dr. Rajkumar Road, Malleshwaram West Bengaluru 560055 Bangalore KARNATAKA	9845281450 karvasudevan@gmail.com
Dr Dilip Kumar	Medica Superspecialty Hospital	Department of Cardiology, 127, Eastern Metropolitan Bypass, Nitai Nagar, Mukundapur, Kolkata, West Bengal,700099 Kolkata WEST BENGAL	9748487563 dilipcardio@gmail.com
Dr Sharath Reddy Annam	Medicover Hospitals	Out Patient Department Block, 2nd floor,Medicover Hospitals, Opposite Cyber Gateway, HUDA Techno Enclave, HITEC City, Hyderabad Hyderabad TELANGANA	9440087532 dr.sharathdm@gmail.com
Dr Blessvin Jino	Meditrina Hospitals	Department of Interventional Cardiology, Meditrina Hospitals, Ayathil, P.O, Kollam, 691021, Kerala Kollam KERALA	9791424314 blesstvmc@gmail.com
Dr Selvamani Sethuraman	Meenakshi Mission Hospital & Research Centre	Department of Cardiology, Lake Area, Melur Road, Madurai-625107 Tamil Nadu, India Madurai TAMIL NADU	0 maniselvacardio@gmail.com
Dr Shafeeq Mattummal	Meitra Hospital	Department of Cardiology, Karaparamba â€“ Kunduparamba, Mini Bypass Rd, Edakkad, Kozhikode Kerala 673005 Kozhikode KERALA	9947667762 drshafeeqm@gmail.com
DrHitendraMBhagwatkar	N. K. P. SALVE INSTITUTE OF MEDICAL SCIENCES & RESEARCH CENTRE	Department of Cardiology, Digdoh Hills, Hingna Road, Nagpur-440019 Nagpur MAHARASHTRA	9096115922 hitendrabhagwatkar@gmail.com
Dr Madhu Sreedharan	NIMS Medicity	Dept of Cardiology, NIMS Medicity, Aralumoodu, Neyyattinkara, Thiruvananthapuram, 695123 Thiruvananthapuram KERALA	9447965207 madhusreedharan@yahoo.com
Dr Suresh Davis	Rajagiri Hospital	Dept Interventional Cardiology, Chunangamvely,Aluva Ernakulam KERALA	0 Suresh.Davis@rajagirihospital.com
Dr Chirag Sheth	Rhythm Heart Institute	Depart of Cardiology, Near Siddharth Bunglows, Sama-Savli Road, Vadodara-390022 Vadodara GUJARAT	9099071144 drcvs_73@yahoo.co.in
Dr Arun Mohanty	Sir Ganga Ram Hospital	Out Patient Department SGRH Marg, Rajinder Nagar New Delhi-110060 New Delhi DELHI	9810385659 arunmohanty25@hotmail.com
Dr Gaurav Verma	SMBT Heart Insitute	Dept Interventional Cardiology Nandi Hills, Dhamangoan, Nashik Nashik MAHARASHTRA	9834100799 drgauravrtk@rediffmail.com
Dr S Nagendra Boopathy	Sri Ramachandra Institute of Higher Education and Research	Department of Cardiology, No.1 Ramachandra Nagar Porur, Chennai, 600116, Tamil Nadu, India Chennai TAMIL NADU	7358560284 drsnboopathy@gmail.com
Dr Mahesh nalin kumar	St. Gregorious Medical Mission Hospital	Department of Cardiology, Parumala, Pathanamthitta Kerala Pathanamthitta KERALA	9712956789 drnkmahesh@gmail.com
Dr Asishkumar Mandalay	Starcare Hospital	Department of Cardiology, NH Bypass, Thondayadu Junction, Kozhikode, Kerala, 673017 Kozhikode KERALA	9895443390 asishmandalay@gmail.com
Dr Gautam Swaroop	Tender Palm Super Specialty Hospital	Department of OPD, Amar Shahees Path, Sec-7, Gomati Nagar, Lucknow 226010 Lucknow UTTAR PRADESH	93078 52939 drgautam.swaroop@gmail.com
Dr Milind Kharche	United Ciigma HospitalÂ	Department of Cardiology, United CIIGMA Institute of Medical Sciences Pvt. Ltd. Plot No. 6, 7, Survey No.10, Shahnoorwadi, Dargah Road, Aurangabad-431005, Maharashtra Aurangabad MAHARASHTRA	9922249995 dr.milindk@gmail.com
Dr Selvaganesh Mariappan	Velammal Medical College Hospital and Research Institute	Department of Cardiology, Velammal Medical College Hospital & Research Institute, Madurai-Tuticorin Ring Road, Anuppanadi, Madurai-625009, Tamil Nadu, India Madurai TAMIL NADU	9865852304 selvapacemaker@gmail.com
Dr Prashant Jagtap	Viveka Super Speciality Hospital and Research Centre Pvt Ltd	Dept of Interventional Cardiology, Viveka Super Speciality Hospital, Plot No. 1A, Naik Layout, Subhash Nagar Nagpur 440022 Nagpur MAHARASHTRA	7447441468 pmjagtap@hotmail.com
Dr Raghu Cherukupalli	Yashoda Hospitals	Dept of Cardiology Yashoda Hospitals, Behind Hari Hara Kala Bhavan, SP Roa4 Secunderabad - 500003 Hyderabad TELANGANA	9848155650 raghu@drraghu.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 51
Name of Committee	Approval Status
Aayush Institutional Ethics Committee	Approved
Clinical Research Ethics Committee Medica Hospital	Approved
Ethics Committee Caritas Hospital	Approved
Ethics Committee Kamalnayan Bajaj Hospital	Approved
Ethics Committee Kodlikeri Memorial Hospital	Approved
Ethics Committee Little Flower Hospital and Research Centre	Approved
Ethics Committee Sir Ganga Ram Hospital	Submittted/Under Review
Fortis Hospital Ethics Committee	Approved
Fortis Hospital_IEC	Approved
Fortis Hospital_IEC Bangalore	Approved
Fortis Hospital_IEC Noida	Approved
IEC - MMHRC	Approved
IEC - SMBT IMSRC	Approved
IEC- Amirtha Institute of Medical Sciences	Approved
IEC- DiabcareIndia	Approved
IEC- DiabcareIndia	Approved
IEC-Bandra Holy Family Medical Research	Submittted/Under Review
IEC-Believers Church Medical College Hospital	Approved
IEC-GKNMH	Approved
IEC-NKPSalve Insitute of Medical Sciences	Approved
IEC-Rukmani Birla Hospital	Approved
IEC-Yashoda Academy of Medical Education and Research	Approved
IEC_ Aster MIMS Hospital	Approved
IEC_AH_Bangalore	Approved
IEC_AH_Bangalore	Approved
IEC_AH_Bangalore	Approved
IEC_AH_Bhubaneswar	Approved
IEC_Ananthapuri Hospital	Approved
IEC_Apollo Multispeciality Hospital	Approved
IEC_Apollo Rajashree Hospital	Approved
IEC_Asian Institute Gastroenterology	Approved
IEC_BMR_AH_Chennai	Approved
IEC_BMR_AH_Chennai	Approved
IEC_BMR_AH_Hyderabad	Approved
IEC_CS_AH_International	Approved
IEC_SRIHER	Approved
Independent Ethics Committee Narayana Diagnostics	Approved
Indus International Hospital - IEC	Approved
Institutional Ethics Committe St.Gregorious Medical Mission Hospital	Approved
Institutional Ethics Committee Columbia Asia Hospital	Approved
Institutional Ethics Committee Medicover Hospital	Approved
Institutional Ethics Committee Velammal	Approved
institutional Human Ethics Committee	Approved
Institutional Human Ethics Committee KIMS	Approved
Manipal Hospital-Yeshwanthpur Ethics Committee	Approved
Meditrina Ethics Committee	Approved
NIMS Institutional Ethics Committee	Approved
Rajagiri Hospital Institutional Ethics Committee	Approved
Rhythm Heart Institute Ethics Committee	Approved
Vision Independent Ethics Committee	Approved
Viveka Hospital Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: I220\|\|Subsequent ST elevation (STEMI) myocardial infarction of anterior wall, (2) ICD-10 Condition: I222\|\|Subsequent non-ST elevation (NSTEMI) myocardial infarction, (3) ICD-10 Condition: I259\|\|Chronic ischemic heart disease, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	NA
Comparator Agent	Nil	NA

Inclusion Criteria

Age From	18.00 Year(s)
Age To	90.00 Year(s)
Gender	Both
Details	1. Patients of either gender aged â‰¥18years, with a diagnosis of stable ischemic heart disease (SIHD) or acute coronary syndrome (ACS) 2. PCI with single or multiple DES for the treatment of lesion located at LMCA and defined as diameter stenosis â‰¥50% by visual estimation 3. Patients willing to sign the informed consent form

ExclusionCriteria

Details

1. Patients who have a life expectancy of less than 12 months
2. Contraindication for dual antiplatelet therapy(DAPT)

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
1. Procedural success 2. Rate of MACE	1. In-hospital 2. 12 Months

Secondary Outcome

Outcome	TimePoints
Rate of individual MACE - cardiac death, MI, TLR, TVR	12 Months

Target Sample Size

Total Sample Size="7500"
Sample Size from India="7500"
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)

29/03/2024

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="2"
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

The left main coronary artery is distinguished by its larger diameter, broad distal bifurcation angle and the perfusion of a significant portion of the myocardium. The disease of LMCA are associated with the highest risk of morbidity and mortality among the subsets of coronary artery diseases with 70% damage to the myocardium when compared with other obstructive CADs.

Coronary artery bypass grafting (CABG) has traditionally been the gold standard for the management of patients with LMCA. However, percutaneous coronary intervention (PCI) has emerged as an alternative to CABG owing to its low periprocedural risk and continuous advancement in technology to provide better long-term outcomes and prognosis. Various systematic reviews and meta-analyses have documented clinical outcomes and long-term mortality among patients undergoing LMCA revascularization with CABG and PCI techniques. The drug-eluting stents have been a breakthrough in the PCI of LMCA and literature provides evidence on the safety and efficacy of using these stents in LMCA stenosis

There is a dearth of research on the clinical outcome of PCI for treating lesions in LMCA in India. Considering this, the data for the registry will be collected to assess the clinical outcomes of PCI with DES in patients with lesions in LMCA. This registry will be a prospective, multicentre, observational data collection study involving patients requiring PCI in LMCA.