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CTRI Number  CTRI/2017/10/010137 [Registered on: 18/10/2017] Trial Registered Retrospectively
Last Modified On: 17/10/2017
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   PARK Registry 
Scientific Title of Study   A registry of Primary Precutaneous Coronary Interventions for Acute Elevation ST Elevation Myocardial Infarction in Kerala  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jabir Abdullakutty 
Designation  Principal Investigator 
Affiliation  Lisie Hospital, Kochi 
Address  Department of Cardilogy, Lisie Hospital Kathrikadavu, Kochi -

Ernakulam
KERALA
682017
India 
Phone  9447011773  
Fax    
Email  drjabi@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr PP Mohanan 
Designation  Sub-Investigator 
Affiliation  West Fort Hitech Hospital, Trissur 
Address  Room # 405, Department of cardiology, West Fort Hitech Hospital, Guruayoor Road, Punkunnam, Thrissur -

Thrissur
KERALA
680002
India 
Phone  9846076006  
Fax    
Email  drppmohanan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr PP Mohanan 
Designation  Sub-Investigator 
Affiliation  West Fort Hitech Hospital, Trissur 
Address  Room # 405, Department of Cardiology, West Fort Hitech Hospital, Guruayoor Road, Punkunnam, Thrissur -

Thrissur
KERALA
680002
India 
Phone  9846076006  
Fax    
Email  drppmohanan@gmail.com  
 
Source of Monetary or Material Support  
Cardiological Society of India- Kerala Chapter. Heart House, Mampilli Estate, Kundanoor, Maradu PO, Kerala, 682304 
 
Primary Sponsor  
Name  Cardiological Society of India Kerala Chapter 
Address  Kerala heart House, 2/280, Mampili Estate, Kundanoor, Marad PO, Kochi 682304 
Type of Sponsor  Other [Doctors organiation] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 37  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jayakumar T G  Amala Medical College  Department of Cardiology, SH69, Amalanagar, Thrissur- 680555
Thrissur
KERALA 
9847261476

jayakumartg@yahoo.com 
Dr CG Bahuleyan  Ananthapuri Hospitals and Research Institute  Room, 485, Chacka, Thiruvananthapuram, Kerala, 695024
Thiruvananthapuram
KERALA 
9447344882

bahuleyan2001@yahoo.co.uk 
Dr James Thomas  Bharath Hospital  Bharath Hospital Dept. of Cardiology,Room 55, Near Bhavana Hospital, Azad Ln, Puthenangady, Kottayam - 686001
Kottayam
KERALA 
9447126044

drjamesthomas@rediffmail.com 
Dr Deepak Davidson  Caritas Hospital  Caritas Hospital Dept of Cardiology,Room 29, Off M.C. Road, Thellakom, Kottayam, Kerala - 686630
Kottayam
KERALA 
9447216959

deepakdavidson@yahoo.com 
Dr Mangalanandan  Cosmopolitan Hospital  Cosmopolitan Hospital Dept of cardiology, Room 53-B, Pattom, Trivandrum - 695004
Thiruvananthapuram
KERALA 
9387805594

mangalanandan@gmail.com 
Dr George Mathew Neerakkal  Edappal Hospital  Edappal Hospital Dept of Cardiology, Room 77-B, Pattambi Road, Edappal, Malappuram - 679576
Malappuram
KERALA 
9495194785

drgeorgemathewn@hotmail.com 
Dr Sunil Pisharody  EMS Hospital  EMS Hospital, Room 119, Dept of Cardiology, Panambi, Malappuram, Perinthalmanna - 679322
Malappuram
KERALA 
9846870719

sunilpisharody@yahoo.co.in 
Dr S S Binu  Gokulam Medical College  Gokulam Medical College Dept. of cardiology, Room 87-A, Venjaramoodu P.O., Thiruvananthapuram - 695607
Thiruvananthapuram
KERALA 
9447006006

binuss@gmail.com 
Dr George Koshy  Govt. Medical College  Medical College Dept of cardiology, Room # 277, Ulloor Road, Thiruvananthapuram, Kerala 695011
Thiruvananthapuram
KERALA 
9847350381

drgkoshy@yahoo.com 
Dr Rajesh G  Govt. Medical College  Medical College Dept of Cardiology, Room 561, Medical College Rd, Kozhikode, Kerala 673008
Kozhikode
KERALA 
9447011100

drrajeshgnair@gmail.com 
Dr VLJayaprakash  Govt. Medical College  Dept of Cardiology, Roon # 66, Gandhinagar P.O., Kottayam 686008
Kottayam
KERALA 
9447289030

drvljp@yahoo.com 
Dr Muhammed Cholakkal  Iqraa International  Iqraa International, Cardiology Division,Room # 42-B, Wayanad Road, Malaparamba, Kozhikode, Kerala 673009
Malappuram
KERALA 
9847142869

cholackal@yahoo.com 
Dr Prasannakumar  Jubilee Mission Medical College  Department of Cardiology, Room # 221 P. O. Jubilee Mission, Bishop Alappat Road,Thrissur - 680005
Thrissur
KERALA 
9447007819

pkumarck@gmail.com 
Dr Ramakrishna pillai  KIMS Hospital  KIMS Hospital Dept of cardiology, Room.No.188, Anayara P.O, Thiruvananthapuram, Kerala 695029
Thiruvananthapuram
KERALA 
9847016321

drvrkpillai@gmail.com 
Dr Thomas Mathew  KVM Hospital  P.B. No. 30, Cherthala, Alappuzha, Kerala - 688524
Alappuzha
KERALA 
9447399564

tmathew2007@gmail.com 
Dr Jayagopal P B  Lakshmi Hospital  Lakshmi Hospital Dept of Cardiology, Room 198, No. 17/751, Chittur Road, Palakkad, Kerala - 678013
Palakkad
KERALA 
9847023777

jaigopallakshmi@gmail.com 
Dr Jabir Addullakutty  Lisie Hospital  Department of cardiology, Room# 405, Kathrikadavu, Kochi - 682017
Ernakulam
KERALA 
9447011773

drjabi@yahoo.co.in 
Dr Biju Issac  Marian Medical Centre  Marian Medical Centre Dept. of Cardiology, Room # 551, Arunapuram, Pala, Kottayam, Kerala - 686574
Kottayam
KERALA 
9497207383

bci.mes@gmail.com 
Dr Ali Faizal  MIMS HOSPITAL  MIMS HOSPITAL Dept of Cardiology,Roon 201 Mini By-pass Road, Govindapuram, Kozhikode, Kerala 673016
Kozhikode
KERALA 
9846117559

faizalali@yahoo.co.in 
Dr Pintu  Modern Hospital  P.B. No. 22, Kodungallur Post, Kodungallur - 680664
Ernakulam
KERALA 
9388887877

drpkpintu@gmail.com 
Dr Anoop Mathew  MOSC Medical College,  Room# 118, Department of cardiology, Medical College Road, PO kolencherry, Kochi - 682311
Ernakulam
KERALA 
8281502606

anoopmatts@gmail.com 
Dr K J James  Mother Hospital  Department of Cardilogy, Roon 662, Pullazhi, Olarikkara, Thrissur, Kerala - 680012
Thrissur
KERALA 
9846016861

drjameskj@hotmail.com 
Dr Madhu Sreedharan  NIMS Hospital  NIMS Hospital Dept of cardiology, Room 344, Aralumoodu, Neyyattinkara, Thiruvananthapuram - 695123
Thiruvananthapuram
KERALA 
9447965207

madhusreedharan@yahoo.com 
Dr SM Ashraf   Pariyaram Medical College  Dept of Cardiology, New Block,Room 44, Pariyaram MC Campus Road, Pariyaram, Kannur, Kerala 670503
Kannur
KERALA 
9447486033

ashsmfz@yahoo.com 
Dr Tiny Nair  PRS Hospital  PRS Hospital Department of cardiology, Room 534, Killipalam, Trivandrum - 695002
Thiruvananthapuram
KERALA 
9847061455

tinynair@gmail.com 
Dr Venugopal  Pushpagiri Medical College Hospital  Department of Cardiology, Room 512, Near Municipal Stadium Pushpagiri Marg, Thiruvalla - 689101
Pathanamthitta
KERALA 
9847005444

drkvenugopal@hotmail.com 
Dr Ramdas Naik  Rajagiri Hospital  Rajagiri Hospital Dept of Cardiology, Room 544, Aluva - Munnar Rd, Chunagamvely, Aluva - 683112
Ernakulam
KERALA 
8547817009

ramdasnayakh@gmail.com 
Dr Shafique Rahman  Renai Medicity  Department of Cardiology,Room # 229 NH 47A, Mamangalam, Palarivattom, Cochin, Kerala 682025
Ernakulam
KERALA 
9846676393

drshafiq78@gmail.com 
Dr Rajalekshmi  S.U.T. HOSPITAL  S.U.T. HOSPITAL Dept of Cardiology, Room 114, Pattom Palace, Trivandrum - 695004
Thiruvananthapuram
KERALA 
9447730789

rajisangee@yahoo.com 
Dr Saji Subramaniyan  Samaritan Heart Institute  Roo, # 26, Department of Cardiiology, Pazhanganad, Kochi, Kerala 683562
Ernakulam
KERALA 
9895555251

drsajisubramanian@gmail.com 
Dr Anand Sreenivasan  SGCVC Hospital  Department of Cardiology, Room 104, Hospital Road, Parumala, Thiruvalla, Kerala - 689626
Pathanamthitta
KERALA 
9447070519

jayasreeanand6@gmail.com 
Dr K Suresh  SK Hospital  SK Hospital Dept of cardiology, Room 187, Edappazhinji, Pangode, Thiruvananthapuram - 695006
Thiruvananthapuram
KERALA 
9846011402

ksureshj4@gmail.com 
Dr Jain T kallarakkal  St Marys Hospital  Department of Cardiology, Room # 32, Thodupuzha - Moolamattom Rd, Thodupuzha - 685584
Alappuzha
KERALA 
9446591453

doctorjain1973@yahoo.com 
Dr Madhu Poulose  St. Gregorios Medical Mission Hospital  St. Gregorios Medical Mission Hospital Dept of cardiology, Room 77-B, Thiruvalla, Pathanamthitta Dist, Parumala - 689626
Pathanamthitta
KERALA 
9447465318

madhuvalayil@gmail.com 
Dr Thomas John  St. James Hospital  Department of Cardiology, Room # 335, Anamala, Old Highway, Chalakudy, Thrissur - 680307
Thrissur
KERALA 
9447307870

thomas_john99@yahoo.com 
Dr Jayakumar B  Thangam Hospital  Thangam Hospital Dept of Cardiology,Room 461, Chadanamkurussi, West Yakkara, Palakkad - 678004
Palakkad
KERALA 
9495501232

drjayakumarb@yahoo.com 
Dr P P Mohanan  Westfort Hi-tech Hospital  Department of Cardiology, Room, 446, Guruayoor Road, Punkunnam, Thrissur - 680002
Ernakulam
KERALA 
9846076006

drppmohanan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 37  
Name of Committee  Approval Status 
Ethics Commitee CSI-K for Iqraa International, Cardiology Division,Room # 42-B, Wayanad Road, Malaparamba, Kozhikode, Kerala 673009 Malappuram KERALA   Approved 
Ethics Commitee, Ananthapuri Hospitals and Research Institute  Approved 
Ethics Commitee, CSI-K for Bharath Hospital Dept. of Cardiology,Room 55, Near Bhavana Hospital, Azad Ln, Puthenangady, Kottayam - 686001 Kottayam KERALA   Approved 
Ethics Commitee, CSI-K for Govt. Medical College Dept of Cardiology, Roon # 66, Gandhinagar P.O., Kottayam 686008 Kottayam KERALA   Approved 
Ethics Commitee, CSI-K for MIMS HOSPITAL Dept of Cardiology,Roon 201 Mini By-pass Road, Govindapuram, Kozhikode, Kerala 673016 Kozhikode KERALA   Approved 
Ethics Commitee, CSI-K for Pushpagiri Medical College Hospital Department of Cardiology, Room 512, Near Municipal Stadium Pushpagiri Marg, Thiruvalla - 689101 Pathanamthitta KERALA   Approved 
Ethics Commitee, SCI-K for Caritas Hospital Dept of Cardiology,Room 29, Off M.C. Road, Thellakom, Kottayam, Kerala - 686630 Kottayam, KERALA   Approved 
Ethics Committee CSI-K for Jubilee Mission Medical College Department of Cardiology, Room # 221 P. O. Jubilee Mission, Bishop Alappat Road,Thrissur - 680005 Thrissur KERALA   Approved 
Ethics Committee CSI-K for Modern Hospital P.B. No. 22, Kodungallur Post, Kodungallur - 680664 Ernakulam KERALA   Approved 
Ethics Committee, CSI-K for . Gregorios Medical Mission Hospital Dept of cardiology, Room 77-B, Thiruvalla, Pathanamthitta Dist, Parumala - 689626 Pathanamthitta KERALA   Approved 
Ethics committee, CSI-K for Edappal Hospital Dept of Cardiology, Room 77-B, Pattambi Road, Edappal, Malappuram – 679576, Malappuram, KERALA   Approved 
Ethics Committee, CSI-K for Gokulam Medical College Dept. of cardiology, Room 87-A, Venjaramoodu P.O., Thiruvananthapuram - 695607 Thiruvananthapuram KERALA   Approved 
Ethics committee, CSI-K for KIMS Hospital Dept of cardiology, Room.No.188, Anayara P.O, Thiruvananthapuram, Kerala 695029 Thiruvananthapuram KERALA   Approved 
Ethics committee, CSI-K for Medical College Dept of cardiology, Room # 277, Ulloor Road, Thiruvananthapuram, Kerala 695011 Thiruvananthapuram, KERALA   Approved 
Ethics Committee, CSI-K for Medical College Dept of Cardiology, Room 561, Medical College Rd, Kozhikode, Kerala 673008 Kozhikode KERALA   Approved 
Ethics Committee, CSI-K for MOSC Medical College, Room# 118, Department of cardiology, Medical College Road, PO kolencherry, Kochi - 682311 Ernakulam KERALA   Approved 
Ethics Committee, CSI-K for Mother Hospital Department of Cardilogy, Roon 662, Pullazhi, Olarikkara, Thrissur, Kerala - 680012 Thrissur KERALA   Approved 
Ethics Committee, CSI-K for NIMS Hospital Dept of cardiology, Room 344, Aralumoodu, Neyyattinkara, Thiruvananthapuram - 695123 Thiruvananthapuram KERALA   Approved 
Ethics Committee, CSI-K for Pariyaram Medical College Dept of Cardiology, New Block,Room 44, Pariyaram MC Campus Road, Pariyaram, Kannur, Kerala 670503 Kannur KERALA   Approved 
Ethics Committee, CSI-K for PRS Hospital Department of cardiology, Room 534, Killipalam, Trivandrum - 695002 Thiruvananthapuram KERALA   Approved 
Ethics Committee, CSI-K for Renai Medicity Department of Cardiology,Room # 229 NH 47A, Mamangalam, Palarivattom, Cochin, Kerala 682025 Ernakulam KERALA   Approved 
Ethics Committee, CSI-K for S.U.T. HOSPITAL Dept of Cardiology, Room 114, Pattom Palace, Trivandrum - 695004 Thiruvananthapuram KERALA   Approved 
Ethics Committee, CSI-K for Samaritan Heart Institute Room, # 26, Department of Cardiiology, Pazhanganad, Kochi, Kerala 683562 Ernakulam KERALA   Approved 
Ethics Committee, CSI-K for SGCVC Hospital Department of Cardiology, Room 104, Hospital Road, Parumala, Thiruvalla, Kerala - 689626 Pathanamthitta KERALA   Approved 
Ethics Committee, CSI-K for SK Hospital Dept of cardiology, Room 187, Edappazhinji, Pangode, Thiruvananthapuram - 695006 Thiruvananthapuram KERALA   Approved 
Ethics Committee, CSI-K for St Marys Hospital Department of Cardiology, Room # 32, Thodupuzha - Moolamattom Rd, Thodupuzha - 685584 Alappuzha KERALA   Approved 
Ethics Committee, CSI-K for St. James Hospital Department of Cardiology, Room # 335, Anamala, Old Highway, Chalakudy, Thrissur - 680307 Thrissur KERALA   Approved 
Ethics Committee, CSI-K, for Cosmopolitan Hospital Dept of cardiology, Room 53-B, Pattom, Trivandrum - 695004 Thiruvananthapuram, KERALA   Approved 
Ethics committee, CSI-K, for EMS Hospital, Room 119, Dept of Cardiology, Panambi, Malappuram, Perinthalmanna – 679322, Malappuram, KERALA   Approved 
Ethics committee, CSI-K, for KVM Hospital P.B. No. 30, Cherthala, Alappuzha, Kerala - 688524 Alappuzha KERALA   Approved 
Ethics Committee, CSI-K, for Lakshmi Hospital Dept of Cardiology, Room 198, No. 17/751, Chittur Road, Palakkad, Kerala - 678013 Palakkad KERALA   Approved 
Ethics Committee, CSI-K, for Marian Medical Centre Dept. of Cardiology, Room # 551, Arunapuram, Pala, Kottayam, Kerala - 686574 Kottayam KERALA   Approved 
Ethics committee, CSI-K, for Rajagiri Hospital Dept of Cardiology, Room 544, Aluva - Munnar Rd, Chunagamvely, Aluva - 683112 Ernakulam KERALA   Approved 
Ethics Committee, CSI-K, for Thangam Hospital Dept of Cardiology,Room 461, Chadanamkurussi, West Yakkara, Palakkad - 678004 Palakkad KERALA   Approved 
Ethics Committee, CSI-K, for Westfort Hi-tech Hospital Department of Cardiology, Room, 446, Guruayoor Road, Punkunnam, Thrissur - 680002 Ernakulam KERALA   Approved 
Ethics Committee,CSI-K, for Amala Medical College Department of Cardiology, SH69, Amalanagar, Thrissur- 680555 Thrissur KERALA   Approved 
Institutional Ethics Committee- Lisie Hospital, Ernakulam  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients undergoing primary angioplasty for acute coronary syndrome.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. All patients more than 18 years presenting with acute ST elevation Myocardial Infarction with symptom duration less than 24 hours, undergoing primary percutaneous coronary interventions (PCI). Diagnostic ST elevation in the absence of LVH or LBBB as defined by ESC/ACC/AHA/World Heart federation task force for the universal definition of Myocardial infarction as new ST elevation at the J point in at least two contiguous leads of more than 2mm in men or > 1.5 mm in women in leads V2-V3 and /or more than or equal to 1 mm in other contiguous chest leads or limb leads. At least one cardiac biomarker elevation above the 99th percentile upper reference limit required.

2. New onset or presumed new onset LBBB in the approprite context of ischemic chest pain will also be considered as STEMI equivalent.
 
 
ExclusionCriteria 
Details  1. Presentation after 24 hours of onset of chest pain
2. Inability to provide informed consent
3. Patients with STEMI who were thrombolyzed at referring hospitals
4. Patients developing STEMI in-hospital following PCI
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
All-cause mortality (1 year)
Composite of all-cause mortality/ non-fatal MI/ TVR/stroke at one year

In-hospital Mortality
 
30/03/2018
 
 
Secondary Outcome  
Outcome  TimePoints 
Cardio vascular Death/Nonfatal MI,/Stroke/Unplanned hopitalisation for ACS or HF at one month

Non-fatal MI at one year

Major Bleed at one year

Stent thrombosis at one year

Hospitalisation for Heart failure or ACS at one year

Target vessel revascularization at one year
 
30/03/2018 
 
Target Sample Size   Total Sample Size="4000"
Sample Size from India="4000" 
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)   30/03/2015 
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)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The Southern Indian state of Kerala has served as a model health delivery system for the rest of India, with the highest life expectancy rates among the Indian states. While cardiovascular diseases are the leading cause of mortality in India, the proportion of population dying from cardiovascular diseases is even higher in Kerala, with cardiovascular mortality rates exceeding those of industrialized nations. Population level interventions to effect primary prevention of cardiovascular diseases are imminently required to achieve sustainable reduction in the burden of cardiovascular diseases. There is a high prevalence of conventional cardiovascular risk factors including diabetes, hypertension, dyslipidemia and central obesity in Kerala. When seen in the context of a projected increase in the prevalence of diabetes in India over the next few decades, an alarming increase in the incidence of cardiovascular diseases can be expected. Acute coronary syndromes especially ST elevation myocardial infarction (STEMI) continues to be among one of the leading cause of cardiovascular mortality in Kerala. In order to reduce mortality and improve long-term outcomes following STEMI it is essential to develop systems of care to facilitate rapid reperfusion in these patients, using appropriate pharmacologic and interventional therapies. Over the past five years the state of Kerala has witnessed a rapid expansion in the number of percutaneous coronary intervention (PCI)-capable hospitals which can be designated as receiving centres for STEMI patients. With 71 cardiac catheterization laboratories in the state of Kerala, there is one cardiac catheterization laboratory available per 470,000 population, thereby substantially increasing the numbers of patients who potentially have timely access to cardiac catheterization services. The rates of primary PCI for STEMI have shown only marginalimprovement from 8.0% in the CREATE registry to 12.9% in the Kerala ACS registry (2007-2009). However, contemporary anecdotal evidence points out to more than 80% primary PCI rates for STEMI, at many PCI-capable centres in Kerala. We believe that the rapid expansion of cardiac catheterization services in Kerala offers a unique opportunity to assess the impact of this health infrastructure expansion on STEMI mortality and outcomes.

One of the objectives of the PARK is to ascertain if patients presenting to PCI-capable hospitals in Kerala have a significant improvement in mortality and major adverse cardiovascular events, compared to patients enrolled in the Kerala ACS registry and CREATE registry. The PARK findings will help in analysing how the STEMI cardiac catheterization services and adjunctive pharmacotherapy fare in comparison to current standards (ACC/AHA guidelines).

 
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