| CTRI Number |
CTRI/2011/08/001964 [Registered on: 24/08/2011] Trial Registered Retrospectively |
| Last Modified On: |
02/03/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Registry |
| Study Design |
Other |
|
Public Title of Study
|
Indian Heart Rhythm Society (IHRS) Registry of Atrial Fibrillation (AF) |
|
Scientific Title of Study
|
Indian Heart Rhythm Society (IHRS) Registry of Atrial Fibrillation: Patient Characteristics and Clinical Management Practices |
| Trial Acronym |
IHRS-AFR-2011 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohan Nair |
| Designation |
Director of the Electrophysiology and Arrhythmia Services |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Max Super Speciality Hospital (A unit of Balaji Medical and Diagnostic Research Centre)
Department of Cardiology
108-A, Indraprastha Extension,
Patparganj
East
DELHI
110092
India |
| Phone |
011-43033333 |
| Fax |
011-43170823 |
| Email |
mohan.nair@maxhealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan Nair |
| Designation |
Director of the Electrophysiology and Arrhythmia Services |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Max Super Speciality Hospital (A unit of Balaji Medical and Diagnostic Research Centre)
Department of Cardiology
108-A, Indraprastha Extension,
Patparganj
East
DELHI
110092
India |
| Phone |
011-43033333 |
| Fax |
011-43170823 |
| Email |
mohan.nair@maxhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohan Nair |
| Designation |
Director of the Electrophysiology and Arrhythmia Services |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Max Super Speciality Hospital (A unit of Balaji Medical and Diagnostic Research Centre)
Department of Cardiology
108-A, Indraprastha Extension,
Patparganj
East
DELHI
110092
India |
| Phone |
011-43033333 |
| Fax |
011-43170823 |
| Email |
mohan.nair@maxhealthcare.com |
|
|
Source of Monetary or Material Support
|
| Indian Heart Rhythm Society (IHRS) |
|
|
Primary Sponsor
|
| Name |
Indian Heart Rhythm Society IHRS |
| Address |
E-413 (Basement Floor) Greater Kailash-II, New Delhi-110048, India |
| Type of Sponsor |
Other [Society] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 20 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Darshan Jhala |
1/2 Kumkum Topiwala Estate |
D2, first Floor, Devraj CHS,
S V Road, Goregaon(west)
Mumbai
Mumbai
MAHARASHTRA |
022-28724650
jhala.darshan@gmail.com |
| Dr Rakesh Yadav |
All India Institute of Medical Sciences (AIIMS) |
Department of Cardiology
Ansari Nagar
New Delhi
South
DELHI |
011-26588500
rakeshyadav123@yahoo.com |
| Dr C Narasimhan |
Care Hospital |
CARE Hospital
Road No-1, Banjara Hills, Hyderabad-300034
Hyderabad
ANDHRA PRADESH |
040-66668888
calambur@hotmail.com |
| Dr Hygriv Rao |
Care Hospital |
Exhibition Road
Nampally
Hyderabad
Hyderabad
ANDHRA PRADESH |
040-30417777
hygriv@hotmail.com |
| Dr Ajay Madhukar Naik |
Care Institute of Medical Sciences |
Science City Road,
Nr. Shukan mall,
Sola
Ahmedabad
Gujarat
380050
INDIA
Ahmadabad
GUJARAT |
079-27712771-75
naikajay@yahoo.com |
| Dr S K Dwivedi |
CSM UNIVERSITY |
Department of Cardiology
Lucknow 226003
Lucknow
UTTAR PRADESH |
0522-2257451-3
dr_skdwivedi@rediffmail.com |
| Dr Anil Saxena |
Fortis Escorts Heart Institute |
Department of Cardiac Pacing and Electrophysiology
Okhla Road, New Delhi - 110 025
South
DELHI |
011-2682500213
anil.saxena@hotmail.com |
| Dr Amit Vora |
Glenmark Cardiac Centre |
Flat No.10, Nandadeep,Dr. Ambedkar Road,Matunga (E), Mumbai- 400 019
Mumbai (Suburban)
MAHARASHTRA |
022-24185808
amvora@hotmail.com |
| Dr Amrit Kumar Barooah |
International Hospital |
Lotus Tower
G S Road
Guwahati 781005
Kamrup
ASSAM |
0361-2347700-07
amrit.barooah@gmail.com |
| Dr Raja Selvaraj |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Department of Cardiology
Dhanvantri Nagar, Gorimedu, Pondicherry - 605 006
Pondicherry
PONDICHERRY |
0413-2272380-90
rajajs@gmail.com |
| Dr Ashish Nabar |
K. E. M. Hospital & Seth G. S. Medical College |
CVTC Building, Acharya Donde Marg,
Parel, Mumbai - 400 012
Mumbai
MAHARASHTRA |
022-24107210
ashish_nabar@hotmail.com |
| Dr N P Singh |
Lok Nayak Hospital |
Delhi Gate
Delhi
Central
DELHI |
01123073637
manu_singh@yahoo.com |
| Dr Nagamalesh U M |
M S Ramaih Memorial Hospital |
New BEL Road, MSRIT Post
Bagalore-560054
Bangalore
KARNATAKA |
080-23608888
nagesh.gm@metropolisindia.com |
| Dr Mohan Nair |
Max Super Speciality Hospital (a unit of Balaji Medical & Diagostic Research Centre) |
Department of Cardiology
108-A, Indraprastha Extension,
Patparganj, Delhi
East
DELHI |
011-43033333
mohan.nair@maxhealthcare.com |
| Dr Vanita Arora |
Max Super Speciality Hospital( a unit of Devki Devi Foundation) |
2, Press Enclave Road,
saket
New Delhi
South
DELHI |
011-26515050
vanita.arora@maxhealthcare.com |
| Dr A G Ravi Kishore |
Narayana Hrudayalaya Hospital |
Department of cardiology
258/A, Bommasandra Industrial Area,
Anekal Taluk,
Bangalore 560 099
Bangalore
KARNATAKA |
080-27835005-18
ravikishoreag@yahoo.co.in |
| Dr Aditya Kapoor |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Department of Cradiology
C- Block,
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Raibareli Road, Luckow
Lucknow
UTTAR PRADESH |
05222494220
akapoor65@gmail.com |
| Dr Shriram Rajagopal |
Southern Railway Headquarters Hospital |
Ayanavaram
Chennai
Chennai
TAMIL NADU |
022-26743051
drshriramcardiologist@gmail.com |
| Dr Narayanan Namboodiri KK |
Sree Chitra Tirunal Institute for medical sciences and Technology |
Trivendrum
Thiruvanathapuram
Pin-695011
Thiruvananthapuram
KERALA |
0471-2443152
kknnamboodiri@gmail.com |
| Dr Yash Lokhandwala |
Yash Lokhandwalas Clinic |
Parag Niketan, Ground floor, Green Avenue, Near Juhu Circle signal,NS Road 10, JVPD Scheme, Mumbai
Mumbai (Suburban)
MAHARASHTRA |
022-26201068
yashlokhandwala@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 20 |
| Name of Committee |
Approval Status |
| Ethical Review Board, M S Ramaih Memorial Hospital, Bangalore |
Approved |
| Independent Ethics Committee |
Approved |
| Independent Ethics Committee, Pune |
Approved |
| Independent Ethics Committee, Thane |
Approved |
| Institutional Ethics Committee Care Hospital, Hyderabad |
Approved |
| Institutional Ethics Committee Care Hospital,Hyderabad |
Approved |
| Institutional Ethics Committee Care Institute of Medical Sciences,Ahmedabad |
Approved |
| Institutional Ethics Committee CSM UNIVERSITY, Lucknow |
Approved |
| Institutional Ethics Committee K. E. M. Hospital & Seth G. S. Medical College, Mumbai |
Submittted/Under Review |
| Institutional Ethics Committee Max Super Speciality Hospital (a unit of Balaji Medical & Diagostic Research Centre) |
Approved |
| Institutional Ethics Committee Sanjay Gandhi Post Graduate Institute of Medical Sciences,Lucknow |
Approved |
| Institutional Ethics Committee Sree Chitra Tirunal Institute for medical sciences and Technology |
Approved |
| Institutional Ethics Committee, AIIMS |
Approved |
| Institutional Ethics Committee, International Hospital, Kamrup |
Submittted/Under Review |
| Institutional Ethics Committee, JIPMER |
Approved |
| Institutional Ethics Committee, Lok Nayak Hospital, Delhi |
Approved |
| Institutional Ethics Committee, Narayana Hrudayalaya Hospital |
Approved |
| Institutional Ethics Committee,Fortis Escorts Heart Institute, Delhi |
Approved |
| Institutional Review Board, Max Super Speciality Hospital( a unit of Devki Devi Foundation) |
Approved |
| League health,Independent Ethics Committee, Thane |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
atrial fibrillation, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Male or female (any age)
History of AF or current AF (treated or not and whatever the rhythm at inclusion), with at least one AF episode in the last 12 months (ECG or ECG-Holter monitoring)
Signed written informed consent obtained from the patient or his/her legal representative
|
|
| ExclusionCriteria |
| Details |
Mental disorder that makes the accuracy of the collected information uncertain |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
o Patient Characteristics (demographics)
o Initial presentation of AF
o Current Management Practices
|
1,6 and 12 month after enrollment/baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
o AF control at 6 months & 12 months
o Other clinical outcomes (thromboembolic events - CV events & stroke)
o INR control
|
At 6 month and 1 year follow up |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
04/07/2011 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The objective of this project is the development of a registry of Atrial Fibrillation patients in India in order to:
1. Find out key demographic features of atrial fibrillation in India
2. Explore how atrial fibrillation is first detected
3. Determine current treatment practices of AF in India: Rate vs Rhythm Control with reason for choosing a particular treatment strategy
4. Use of Anti- thrombotic agents
The data will enhance our understanding on the demographics of atrial fibrillation in India, its treatment patterns, and the reasons for lack of optimal treatment as per the current guidelines. It will also give important information on the current prevalence patterns, as compared to other countries and populations. The data will help identify focus areas that require urgent attention, including patient and physician education. It will also be possible to do subset analysis on this data for populations such as young patients with valvular AF in order to improve their management and reduce complications
- IHRS-AF is a national, observational, cross-sectional registry of patients with AF.
· Approval of the local Institutional Review Board/ Independent Ethics Committee (IRB/IEC) will be sought by the investigator before initiating the registry at each institution.
· Approximately 20 electrophysiology specialists and cardiologists managing cardiac arrhythmias will be selected as investigators.
- A total of 1000 patients would be recruited over a period of 12 months.
- Each investigator will enroll around 50 patients.
- Eligible patients must have current AF (any type or treatment), or a history of AF and at least one AF episode in the past 12 months documented by standard ECG or ECG-Holter monitoring.
· Schedule of visits – Baseline, 6 months and 12 months ( Window Period ±1 Month) |