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
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.
nPrimary Objective: To evaluate the cardiovascular and non-cardiovascular diseases associated with AF and to assess the socio-demographic characteristics of AF patients.
nSecondary Objectives:
1.To estimate the mortality rates among patients with AF in the state.
2.To estimate the incidence of major adverse cardiac and cerebrovascularevents (MACCE) in patients with AF.