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
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).