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CTRI Number  CTRI/2017/10/010097 [Registered on: 13/10/2017] Trial Registered Retrospectively
Last Modified On: 10/10/2017
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Kerala Atrial Fibrillation Registry 
Scientific Title of Study   Registry of Atrial Fibrillation in Kerala: A Multicentre cohort study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr CG Bahuleyan 
Designation  Chairman, Cardiovascular centre, 
Affiliation  Ananthapuri Hospitals and Research Institute 
Address  Cardiovascular centre, Ananthapuri Hospitals and Research Institute, Chacka, Thiruvananthapuram, Kerala, India

Thiruvananthapuram
KERALA
695024
India 
Phone  9447344882  
Fax  04712506969  
Email  bahuleyan2001@yahoo.co.uk  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr CG Bahuleyan 
Designation  Chairman, Cardiovascular centre, 
Affiliation  Ananthapuri Hospitals and Research Institute 
Address  Cardiovascular centre, Ananthapuri Hospitals and Research Institute, Chacka, Thiruvananthapuram, Kerala, India

Thiruvananthapuram
KERALA
695024
India 
Phone  9447344882  
Fax  04712506969  
Email  bahuleyan2001@yahoo.co.uk  
 
Details of Contact Person
Public Query
 
Name  Prof Dr CG Bahuleyan 
Designation  Chairman, Cardiovascular centre, 
Affiliation  Ananthapuri Hospitals and Research Institute 
Address  Cardiovascular centre, Ananthapuri Hospitals and Research Institute, Chacka, Thiruvananthapuram, Kerala, India

Thiruvananthapuram
KERALA
695024
India 
Phone  9447344882  
Fax  04712506969  
Email  bahuleyan2001@yahoo.co.uk  
 
Source of Monetary or Material Support  
Cardiological Society of India, Kerala Chapter. Kochi, Kerala 
 
Primary Sponsor  
Name  Cardiological Society of India Kerala Chapter 
Address  Kerala Heart House, 2/280, I Floor, Mampilli Estate, NH Bypass, Kundanoor, Marad P.O, Kochi, 628 304, Kerala, India 
Type of Sponsor  Other [Society of Cardiologists] 
 
Details of Secondary Sponsor  
Name  Address 
Ananthapuri Hospitals and Research Institute  Thiruvananthapuram, Kerala, 695024. India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 66  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pramod  Aswini Hospital  Dept. of Cardiology, Room, 540, Karunakaran Nambiar Road, Thrissur - 680 020
Thrissur
KERALA 
9447524890

drpramodvk@gmail.com 
Dr Manikandan TV  Elite Hospital  Dept. of Cardiology, Room. 66, Koorkenchery, Thrissur, Kerala 680007
Thrissur
KERALA 
9846158257

tvmankan@yahoo.com 
Dr Anand Kumar  Lakeshore Hospital   Dept. of Cardiology, Room 12-b Nettoor P O, Maradu, Ernakulam, Kerala 682040
Ernakulam
KERALA 
9249488064

anandheart@gmail.com 
Dr Stigi Joseph  Little Flower Hospital  Dept. of Cardiology, Room 12, Angamaly MC Road, Angamaly, Kerala 683572
Ernakulam
KERALA 
9446279889

drstigij@yahoo.com 
Dr Sujith Kumar  Medical Centre Ernakulam   Dept. of Cardiology, Room 855, National Highway 47 By Pass, Palarivattom, Kochi, Kerala 682028
Ernakulam
KERALA 
9495329535

drsujithkumar1976@rediffmail.com 
Dr Saji Kuruttukulam  Medical Trust Hospital  Dept. of Cardiology, Room, 45, MG Road, Kochi, Kerala 682016
Ernakulam
KERALA 
9846050005

drsajy@yahoo.com 
Dr Ramdas Naik  Rajagiri Hospital  Dept. of Cardiology, Room, 76, Aluva Kalamassery, Ernakulam, Kerala 683104
Ernakulam
KERALA 
8547817009

ramdasnayakh@gmail.com 
Dr Balakrishnan N  Sunrisre Hospital  Dept. of Cardiology, Room-177 Seaport - Airport Road, Kakkanad, Kochi, Kerala 682030
Ernakulam
KERALA 
9895452289

drbala2@yahoo.com 
Dr Raghu Ram  Al-Shifa Hospital  Dept. of Cardiology, Room, 12-36 Ootty Road, Malappuram District, Perinthalmanna, Kerala 679322
Malappuram
KERALA 
9846402850

raghu_rak@hotmail.com 
Dr Jeyakumar  Amala Institute of Medical Sciences  Dept. of Cardiology, Room, 443, SH69, Amalanagar, Thrissur, Kerala 680555
Thrissur
KERALA 
9847261476

tgjayakumar@gmail.com 
Dr Natarajan KU   Amritha Institute of Medical Sciences   Dept. of Cardiology, Room, 222, Ponekkara, Kochi, Kerala 682041
Ernakulam
KERALA 
9895057660

kunatarajan@gmail.com 
Prof Dr CG Bahuleyan  Ananthapuri Hospitals and Research Institute  Dept. of Cardiology, Room 468, NH Bypass, Thiruvananthapuram, Kerala, India. PIN 695024
Thiruvananthapuram
KERALA 
9447344882
04712506969
bahuleyan2001@yahoo.co.uk 
Dr Anil Kumar R  Aster Medicity   Dept. of Cardiology, Room- 121, Kuttisahib Rd, South Chittoor, Ernakulam, Kerala 682027
Ernakulam
KERALA 
9746980997

dr.r.anilkumar@gmail.com 
Dr Asokan Nambiar  Baby Memorial Hospital   Dept. of Cardiology, Room, 166, Indira Gandhi Road, Arayidathupalam, Kozhikode, Kerala 673004
Kozhikode
KERALA 
9847001142

hrdya@asianetindia.com 
Dr N Sudhayakumar  Bharat Hospital  Dept. of Cardiology, Room, 767, Near Bhavana Hospital, Azad Ln, Puthenangady, Kottayam, Kerala 686001
Kottayam
KERALA 
9447157154

nsudhayakumar@gmail.com 
Dr Sujay Renga  Bishop Benzigar Hospital,  Dept. of Cardiology, Room 11,Beach Road, Kollam 691001
Kollam
KERALA 
9496402146

drssujayrenga@gmail.com 
Dr SajeevCG  Calicut Medical College  Dept. of Cardiology, Room, 909, Medical College Rd, Government Medical College Campus, Kozhikode, Kerala 673008
Kozhikode
KERALA 
9846035722

cgsajeev@gmail.com 
Dr Johny Joseph  Carithas Hospital  Dept. of Cardiology, Room, 334, Off M.C. Road, Thellakom, Kottayam, Kerala 686630
Kottayam
KERALA 
9447124948

johnyjoseph@gmail.com 
Dr Anil Roby  Damodaran Memorial Hospital  Dept. of Cardiology, Room, 12, Jerome Nagar, Mundakkal Village,
Kollam
KERALA 
9447132288

dkdmh65@gmail.com 
Dr Iqbal  Daya Hospital   Dept. of Cardiology, Room, 511, Kodungallur - Shornur Road, Near Viyyur Bridge, Thrissur, Kerala 680022
Thrissur
KERALA 
9447350123

dr_iqbal_pt@yahoo.com 
Dr Syam  District Hospital, Kollam  Dept. of Cardiology, Room 220,Chinnkakkada, Kollam, Kerala, 691001
Kollam
KERALA 
9847074334

drsyamn@yahoo.com 
Dr Sunil Pisharody  EMS memorial co-operative hospital   Dept. of Cardiology, Room, 332, Panambi, Perinthalmanna, Malappuram, Kerala 679322
Malappuram
KERALA 
9846870719

sunilpisharody@yahoo.co.in 
Dr Arun  General Hospital Trivandrum  Dept. of Cardiology, Room 331,Palayam Thiruvananthapuram,Kerala,
Thiruvananthapuram
KERALA 
9446700896

srarun3@gmail.com 
Dr Syam  General Hospital, Thiruvananthapuram  Dept. of Cardiology, Room, 334, Head of Cardiology Department, General Hospital, Thiruvananthapuram, Kerala
Thiruvananthapuram
KERALA 
9847074334

drsyamn@yahoo.com 
Dr SS Binu  Gokulam Heart Foundation  Dept. of Cardiology, Room 98,Venjaramoodu, Thiruvananthapuram,Kerala, 695607
Thiruvananthapuram
KERALA 
9447006006

binuss@gmail.com 
Dr Cibu Mathew  Govt Medical College Hospital, Trissur  Dept. of Cardiology, Room, 655, Thrissur, Kerala 680596
Thrissur
KERALA 
9447393765

lizcibu@rediffmail.com 
Dr Byju  HMS Hospital  Dept. of Cardiology, Room, 87, NH17, Palathara, Kerala 676501
Malappuram
KERALA 
9495022550

byjukachery@gmail.com 
Dr Jessy Chacko  Holycross hospital   Dept. of Cardiology, Room, 453, Salem -Kochi- Kanyakumari Highway, Kottiyam, Kollam, Kerala 691571
Kollam
KERALA 
9447152115

josychacko@yahoo.com 
Dr Sheeba George  Jubilee Hospital, Palayam  Dept. of Cardiology, Room, 120, Palayam, Trivandrum
Thiruvananthapuram
KERALA 
9446011222

ashpra777@yahoo.com 
Dr Govindan Unni  Jubilee Hrudhayalaya  Dept. of Cardiology, Room, 12, PO Jubilee Mission, Thrissur, Kerala 680005
Thrissur
KERALA 
9847308310

unni.govindan@gmail.com 
DrShaffeq Muttummal  KMCT Medical College Hospital  Dept. of Cardiology, Room 776, Malabar Christian College Cross Rd, Kannur Road Junction, Kozhikode, Kerala 673011
Kozhikode
KERALA 
9447667762

drshafeeqm@gmail.com 
Dr Anilkumar MK  Koyili Hospital   Dept. of Cardiology, Room 988,Talap, Pallikkunnu, Kannur, Kerala 670004
Kannur
KERALA 
9846126808

anilcardio@yahoo.com 
Dr Sudhir NM   KVM Hospital  Dept. of Cardiology, Room, 421, P.B # 13, Cherthala, Alapuzha 688 524, Kerala
Alappuzha
KERALA 
9526923922

sudhirnagisetty@gmail.com 
Dr JayagopalPB  Lakshmi Nursing home  Dept. of Cardiology, Room- No. 17/751, Chittur Road, near Manapullikavu Temple, Kenathuparambu, Kunathurmedu, Palakkad, Kerala 678001
Palakkad
KERALA 
9847023777

jaigopallakshmi@gmail.com 
Dr Muhammed Shaloob  Leo Hospital, Wayanad   Dept. of Cardiology, Room 75 Opp Kalpetta New Bus Stand, Kalpetta, Kerala 67312,1
Wayanad
KERALA 
9605886666

shaloob_m@hotmail.com 
Dr Jabir A  Lisie Heart Institute  Dept. of Cardiology, Room, 676,Lisie Hospital Rd, Kathrikadavu, Kaloor, Kochi, Kerala 682017
Ernakulam
KERALA 
9447011773

drjabi@yahoo.co.in 
Dr M Ashish Kumar  Malabar Institute of Medical Sciences  Dept. of Cardiology, Room, 564, Mini By-pass Road, Govindapuram P.O. 673 0164
Kozhikode
KERALA 
9895443390

asishmandalay@indiatimes.com 
Dr Biju Issac  Marian Medical Centre, Palai  Dept. of Cardiology, Room, 99, Ettumanoor Pala Road, Pala, Kerala 686574
Kottayam
KERALA 
9497207383

bci.mes@gmail.com 
Dr Raju George  Medical College Hospital Kottayam  Dept. of Cardiology, Room, 71, MCH Kottayam Gandhinagar P.O., Kottayam, Kerala 686008
Kottayam
KERALA 
9447252072

drrg45@dataone.in 
Dr George Koshy  Medical College, Trivandrum  Dept. of Cardiology, Room 312 Medical College PO, Thiruvananthapuram,Kerala 695011
Thiruvananthapuram
KERALA 
9847250246

ageorgekoshy@gmail.com 
Dr RajeevE  MES Hospital  Dept. of Cardiology, Room, 445, Malaparamba, Palachode Post Kolathur (Via) Angadipuram, Valanchery Nilambur Road, Malappuram, Kerala 679338
Malappuram
KERALA 
9847007556

drrajeev@yahoo.com 
Dr Muhammed Musthaffa  Metro International Hospital  Dept. of Cardiology, Room, 17, Thondayad Bypass Road, Near Highlite City, Palazhi, Kozhikode, Kerala 673014
Kozhikode
KERALA 
9847004444

ppmmusthafa@hotmail.com 
Dr Eappen Punnose  MOSC Medical college   Dept. of Cardiology, Room, 55, Medical College Road, PO kolencherry, Kochi, Kerala 682311
Ernakulam
KERALA 
9447204908

eapenp@hotmail.com 
Dr Geevar Zachariah  Mother Hospital  Dept. of Cardiology, Room, 76, Pullazhi, Olarikkara, Thrissur, Kerala 680012
Thrissur
KERALA 
9846066816

geevarzachariah@gmail.com 
Dr Markose  Moulana Hospital  Dept. of Cardiology, Room, 668, Ooty Road, Perintalmanna, Malappuram, Kerala 679322
Malappuram
KERALA 
9847018750

markosekp@yahoo.com 
Dr Jeyachandran Nair  Nairs Hospital  Dept. of Cardiology, Room 445, Residency Road, Asramam, Kollam, Kerala 691002
Kollam
KERALA 
9447390082

drbsjnair@hotmail.com 
Dr Madhu Sreedharan  NIMS Hospital  Dept. of Cardiology, Room 2016,Aralumoodu, Neyyattinkara, Thiruvananthapuram,Kerala,695123
Thiruvananthapuram
KERALA 
9447965207

madhusreedharan@yahoo.com 
Dr Rachel  NS Hospital  Dept. of Cardiology, Room 208,Mylapure, Palathara, Thazhuthala
Kollam
KERALA 
984702204

rachelphy@gmail.com 
Dr Tiny Nair  PRS Hospital, Karamana  Dept. of Cardiology, Room 210, Karamana, Thiruvananthapuram, 695002
Thiruvananthapuram
KERALA 
9847061455

tinynair@gmail.com 
Dr Blessan Varghese  PVS Hospital   Dept. of Cardiology, Room, 65-A NH Road, Kaloor, Next to The Gokulam Park, Cochin, Kerala 682017
Ernakulam
KERALA 
9400392027

blessanv@gmail.com 
Dr HarikrishnaD  PVS Hospital  Dept. of Cardiology, Room,887, Railway Station Rd, Palayam, Kozhikode, Kerala 673002
Kozhikode
KERALA 
9746624804

drhkd_77@yahoo.com 
Dr Vinod Thomas  Renai Medicity  Dept. of Cardiology, Room, 100, NH 47A, Mamangalam, Palarivattom, Cochin, Kerala 682025
Ernakulam
KERALA 
9847060345

vinutom1@gmail.com 
Dr Kiran Gopinath  RIMS, Erattupetta   Dept. of Cardiology, Room, 577, Pala Road, Erattupetta, Kottayam, Kerala 686121
Kottayam
KERALA 
9349354470

kirangopinathpanicker@gmail.com 
Dr Jaideep Menon  S.N.Hospital  Dept. of Cardiology, Room, 19, Manjali, Chalakka, North Kuthiyathodu P.O., Ernakulam Dist, Kerala - 683 594, India
Ernakulam
KERALA 
9447352684

menon7jc@gmail.com 
Dr Koshy Eapen  Samaritan Hospital  Dept. of Cardiology, Room, 799, Pazhanganad, Kochi, Kerala 683562
Thrissur
KERALA 
9447022212

e-kosh@hotmail.com 
Dr Sreekala  SIMS Hospitals  Dept. of Cardiology, Room,88,Kandanmukku Kollam,Kerala
Kollam
KERALA 
9447367128

kalapdr@yahoo.com 
Dr K Suresh  SK Hospital,   Dept. of Cardiology, Room 11,Edappazhinji, Pangode, Thiruvananthapuram,Kerala, 695006
Thiruvananthapuram
KERALA 
9846011402

ksureshj4@gmail.com 
Prof Dr Narayanan Namboodiri  Sree Chitra Tirunal Institute of medical Sciences and Technology  Dept. of Cardiology, Room 312 Medical College PO, Thiruvananthapuram, 695011
Thiruvananthapuram
KERALA 
9447223340

kknnamboodiri@gmail.com 
Dr Mathew Abraham   St. Mary’s Hospital  Dept. of Cardiology, Room, 454, Thodupuzha - Moolamattom Rd, Thodupuzha, Kerala 685584
Idukki
KERALA 
9447747225

mathewacardio@gmail.com 
Dr S Rajalekshmi  SUT Hospital  Dept. of Cardiology, Room 101,Pattom Palace, Thiruvananthapuram,Kerala,695004
Thiruvananthapuram
KERALA 
9447730789

rajisangee@yahoo.com 
Dr JayakumarB  Thankam Hospital   Dept. of Cardiology, Room, 6671, Chadanamkurussi, West Yakkara, Palakkad, Kerala 678004
Palakkad
KERALA 
9495501232

drjayakumarb@yahoo.com 
Dr Ramesh  Travancore Medical College   Dept. of Cardiology, Room- 26, N.H. Bypass Road, Umayanalloor, Kollam, Kerala 691589
Kollam
KERALA 
9447207588

drramesh@gmail.com 
Dr Vikram Shankar  Valluvanadu Hospital   Dept. of Cardiology, Room, 94 Killickkavu Temple Rd, Kanniyampuram Ottapalam, Kerala 679521
Palakkad
KERALA 
9995889521

vikramsankar05@yahoo.com 
Dr Anil Kumar  VSM Hospital  Dept. of Cardiology, Room, 554, Thattarambalam, Mavelikara, Kerala 690103
Alappuzha
KERALA 
9447265345

dranilkn@gmail.com 
Dr Anoop Gopinath  Welcare Hospital  Dept. of Cardiology, Room, 97, Welcare Junction, Near Mercy College, Palakkad, Kerala 678006
Palakkad
KERALA 
9744068178

dranoopgopinath@gmail.com 
Dr PP Mohanan  Westfort Hi Tech Hospital  Dept. of Cardiology, Room, 343, Guruayoor Road, Punkunnam, Thrissur, Kerala 680002
Thrissur
KERALA 
9846076006

drppmohanan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 66  
Name of Committee  Approval Status 
Ethics Committee, CSI-K, for SK hospital, Thiruvananthapurmam,  Approved 
Ethics Commitee, Cardiological Society of India, Kerala Chapter  Approved 
Ethics Commitee, CSI-K, for PRS Hospital, Karamama  Approved 
Ethics Committee, CSI-K for MES Hospital, Malappuram  Approved 
Ethics Committee, CSI-K for Thankam Hospital,   Approved 
Ethics Committee, CSI-K for Al_shifa Hospital, Perinthalmanna  Approved 
Ethics Committee, CSI-K for Babu Memorial Hospital  Approved 
Ethics Committee, CSI-K for Dhanalekshmi Hospital, Kannur  Approved 
Ethics Committee, CSI-K for EMS memorial Hospital, Malappuram  Approved 
Ethics Committee, CSI-K for HMS Hospital, Palathara  Approved 
Ethics Committee, CSI-K for Koyili Hospital  Approved 
Ethics Committee, CSI-K for Lekshmi Nursing Home, Palakkad   Approved 
Ethics Committee, CSI-K for Leo Hospital, Wayanad  Approved 
Ethics Committee, CSI-K for Lisie Hospital, Ernakulam  Approved 
Ethics Committee, CSI-K for Malabar Institute of Medical Sciences  Approved 
Ethics Committee, CSI-K for Metro International Hospital, Calicut  Approved 
Ethics Committee, CSI-K for Moulana Hospital, Malappuram  Approved 
Ethics Committee, CSI-K for PVS Hospital   Approved 
Ethics Committee, CSI-K for Welcare Hospital, Palakkad  Approved 
Ethics Committee, CSI-K, for   Approved 
Ethics Committee, CSI-K, for Amala Institute of Medical Sciences Kochi  Approved 
Ethics Committee, CSI-K, for Aster Medicity, Ernakulam  Approved 
Ethics Committee, CSI-K, for Aswini Hospital, Trichur  Approved 
Ethics Committee, CSI-K, for Bharat Hospital, Kottayam  Approved 
Ethics Committee, CSI-K, for Daya Hospital, Trichur  Approved 
Ethics Committee, CSI-K, for District Hospital, Kollam  Approved 
Ethics Committee, CSI-K, for Dr.Damodar Memorial Hospital, Kollam   Approved 
Ethics Committee, CSI-K, for Elite Hospital, Trichur  Approved 
Ethics Committee, CSI-K, for General Hospital, Thiruvananthapuram  Approved 
Ethics Committee, CSI-K, for Gokulam Heart Foundation  Approved 
Ethics Committee, CSI-K, for Government Medical College, Trichur  Approved 
Ethics Committee, CSI-K, for Holicross Hospital, Kottiyam  Approved 
Ethics Committee, CSI-K, for Jubilee Hirudayalaya, Trichur  Approved 
Ethics Committee, CSI-K, for Jubilee Hospital, Thiruvananthapuram  Approved 
Ethics Committee, CSI-K, for KVM Hospital, Alapuzha  Approved 
Ethics Committee, CSI-K, for Lakeshore Hospital, Maradu  Approved 
Ethics Committee, CSI-K, for Little flower Hospital, Angamali  Approved 
Ethics Committee, CSI-K, for Mariyn Medical Centre, Palai  Approved 
Ethics Committee, CSI-K, for MCH, Kottayam  Approved 
Ethics Committee, CSI-K, for Medical Centre, Ernakulam  Approved 
Ethics Committee, CSI-K, for Medical Trust Hospital, Koc  Approved 
Ethics Committee, CSI-K, for MOSC Medical College, Kolencherry  Approved 
Ethics Committee, CSI-K, for Mother Hospital, Trichur  Approved 
Ethics Committee, CSI-K, for Nairs Hospital, Kollam  Approved 
Ethics Committee, CSI-K, for NS Hospital, Kollam  Approved 
Ethics Committee, CSI-K, for PVS Hospital, Cochin  Approved 
Ethics Committee, CSI-K, for Ragagiri Hospital, Ernakulam  Approved 
Ethics Committee, CSI-K, for Renai Heart Institute  Approved 
Ethics Committee, CSI-K, for RIMS, Erattupatta  Approved 
Ethics Committee, CSI-K, for S.N. Hospital, Manjali  Approved 
Ethics Committee, CSI-K, for Samaritan Hospital, Kochi  Approved 
Ethics Committee, CSI-K, for SIMS, Kollam  Approved 
Ethics Committee, CSI-K, for Sunriase Hospital, Kakkanad  Approved 
Ethics Committee, CSI-K, for SUT hospital, Pattom, Thiruvananthapuram  Approved 
Ethics Committee, CSI-K, for Travencore Medical College, Kollam  Approved 
Ethics Committee, CSI-K, for Vijaya Hospital, Kottarakkara  Approved 
Ethics Committee, CSI-K, for VSM hospital, Mavelikkara  Approved 
Ethics Committee, CSI-K, for Westfort HI Tech Hospital, Trichur  Approved 
Ethics Committee, CSI-K, NIMS Hospital, Neyyattinkara  Approved 
Human Ethics Commitee, Govt. Medical College, TVM  Approved 
Institional Ethics Commitee, Amritha Institute of Medical Sciences  Approved 
Institutional Ethics Commitee  Approved 
Institutional Ethics Commitee, Carithas Hospital  Approved 
Institutional Ethics Commitee, Shree narayana Institute of medical sciences  Approved 
Institutional Ethics Committee, Ananthapuri Hospitals and Research Institute  Approved 
Institutional Ethics Committee, Government Medical College, Kozhikode, Kerala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Atrial Fibrillation,  
 
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 newly diagnosed and existing cases with ECG evidence of AF
2. Patients above 18 years
 
 
ExclusionCriteria 
Details  1. Transient AF due to reversible causes like Acute Myocardial Infarction, Infection, Metabolic abnormalities, Alcoholic Intoxication and post-operative.
2. Critically ill patients with life expectancy less than 30 days.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Cardiovascular death,
Stroke or transient ischemic attack,
Myocardial infarction,
Peripheral embolism
Hospitalization for arrhythmia,
Hospitalization for: cardiovascular events or intervention, chronic heart failure, acute coronary syndrome
 
1 year

 
 
Secondary Outcome  
Outcome  TimePoints 
1. To estimate the mortality rates among patients with AF in the state.
2. To estimate the incidence of major adverse cardiac and cerebrovascular events (MACCE) in patients with AF.
 
5 years 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="2000" 
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)   04/04/2016 
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)   Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Background

Kerala was held up to the world as ‘good health at low cost’. Human development index (HDI) for Kerala is highest in India. Geographically Kerala is situated at the south-west tip of India with an estimated population of 34 million.

Atrial fibrillation (AF) is the most common form of chronic cardiac arrhythmia and its prevalence is likely to increase in the next decades.  AF is independently associated with increased risk of stroke and death. AF is associated with a six fold increase in stroke risk, contributing 20-25% of ischaemic stroke in older patients. The incidence of AF doubles with successive age decades after the age of 50 years. Hypertension is the most common comorbidity in AF patients, and globally there has been a steady increase in hypertension prevalence in AF patients from 53% to 83% over the last 20 years.

Very little is known about the prevalence, aetiology and treatment pattern of AF in India and continued data collection through a registry can improve understanding of AF in India. In some rural parts of India, Rheumatic heart disease (RHD) had been reported as the most common factor for AF. In Kerala it has been observed that hypertension is the important factor leading to AF, just like that in the western countries. Though this transition is well appreciated in Kerala, it is not documented through scientific study.

Rationale

Data on Atrial Fibrillation patients from the State of Kerala is lacking. This study will be initiated as state-wide patient registry to document the etiology and socio demographic characteristics of AF patients in the state and the current standard of care as well as short to medium term mortality rate of  AF patients in Kerala.  All patients will be followed up at 30 days, 6 months and 1,2,3,4 and 5 years, for clinical outcome. A database will be created for further scientific study to improve treatment for AF in Kerala.

Clinical Outcome:  Cardiovascular death,

Stroke or transient ischemic attack,

Myocardial infarction,

Peripheral embolism

Hospitalization for arrhythmia,

Hospitalization for: cardiovascular events or intervention, chronic heart failure, acute coronary syndrome.

n  Primary Objective: To evaluate the cardiovascular and non-cardiovascular diseases associated with AF and to assess the socio-demographic characteristics of AF patients.

n  Secondary Objectives:

1.      To estimate the mortality rates among patients with AF in the state.

2.      To estimate the incidence of major adverse cardiac and cerebrovascular  events (MACCE) in patients with AF. 

 
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