| CTRI Number |
CTRI/2018/10/016055 [Registered on: 17/10/2018] Trial Registered Prospectively |
| Last Modified On: |
16/10/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Andhra Pradesh Atrial Fibrillation Study |
|
Scientific Title of Study
|
Population based prevalence study of Atrial Fibrillation in Rural Andhra Pradesh |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrCalambur Narasimhan |
| Designation |
Cardiac Electrophysiologist |
| Affiliation |
CARE hospital |
| Address |
Department of Cardiac Electrophysiology
CARE Hospital, Road No.1
Department of Cardiac Electrophysiology
CARE Hospital, Road No.1
Hyderabad
ANDHRA PRADESH
500028
India |
| Phone |
|
| Fax |
|
| Email |
calambur1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrCalambur Narasimhan |
| Designation |
Cardiac Electrophysiologist |
| Affiliation |
CARE hospital |
| Address |
Department of Cardiac Electrophysiology
CARE Hospital, Road No.1
Department of Cardiac Electrophysiology
CARE Hospital, Road No.1
Hyderabad
ANDHRA PRADESH
500028
India |
| Phone |
|
| Fax |
|
| Email |
calambur1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrCalambur Narasimhan |
| Designation |
Cardiac Electrophysiologist |
| Affiliation |
CARE hospital |
| Address |
Department of Cardiac Electrophysiology
CARE Hospital, Road No.1
Department of Cardiac Electrophysiology
CARE Hospital, Road No.1
Hyderabad
ANDHRA PRADESH
500028
India |
| Phone |
|
| Fax |
|
| Email |
calambur1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Boehringer Ingelheim India Private Limited |
|
|
Primary Sponsor
|
| Name |
Boehringer Ingelheim India Private Limited |
| Address |
1102, 11th Floor, Hallmark Business Plaza,
Gurunanak Hospital Road,
Near Gurunanak Hospital,
Bandra (East), Mumbai – 400 051
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CARE Foundation |
8-2-595/2/B, CARE Convergence Centre, CARE Foundation,Road No.10, Banjara Hills, Hyderabad-34 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Calambur Narasimhan |
CARE Foundation |
Department of Electrophysiology,Road No.10, Banjara Hills
Hyderabad
ANDHRA PRADESH |
04030418888
04030418488
calambur1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All participants irrespective of health conditions |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Men and women aged eighteen years and above
2.Willing to participate in the study by signing the informed consent form
|
|
| ExclusionCriteria |
| Details |
1.Individuals not willing to participate in the study.
2.Individuals who are not resident of the selected villages.
3.Individuals who haven’t followed instructions for blood glucose testing
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Not applicable. Presence of Atrial Fibrillation on ECG is considered as a case for this prevalence study. |
The study would end approximately in Febrauary 2019 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="11021"
Sample Size from India="11021"
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)
|
22/10/2018 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a population-based prevalence study of Atrial Fibrillation in Rural Andhra Pradesh. The main objectives of the study are to assess the prevalence of atrial fibrillation in the adult population of rural areas of East and West Godavari Districts and, to study its cardiovascular risk profile. Undetected or suboptimally treated patients with atrial fibrillation are at high risk for stroke. The study aims to assess the burden of the condition and also understand the population’s health profile to understand the factors affecting the diagnosis of the condition and its optimal management. Sampling will be done in two stages: Forty villages in the two districts will be selected by Probability Proportional to Size sampling method. In the second stage, individuals aged 18 years and above will be selected by age and sex-stratified by simple random sampling. The study will be conducted on 11,021 participants.
The study will be done in two stages. In stage 1-on Day 1, using a door-to-door survey method, basic information such as anthropometric measurements, cardiovascular risk factors, awareness of cardiovascular risk, health-seeking behaviour and medical history will be collected. ECG will be recorded for all participants using a Smartphone compatible, hand-held ECG machine. On Day 2, fasting blood samples for glucose and lipid profile will be drawn. During stage 2, patients identified with atrial fibrillation by ECG will be further assessed for etiology for AF (using echocardiogram), risk factors for stroke and treatment (if any) adequacy. |