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CTRI Number  CTRI/2025/07/090466 [Registered on: 08/07/2025] Trial Registered Prospectively
Last Modified On: 07/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To study etiological factors and clinical profile in patients of atrial fibrillation  
Scientific Title of Study   TO STUDY ETIOLOGICAL FACTORS AND CLINICAL PROFILE IN PATIENTS OF ATRIAL FIBRILLATION 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Suyog Goswami 
Designation  Junior Resident 
Affiliation  DY Patil Medical College 
Address  3rd floor, Department of General Medicine, DY Patil Hospital, Nerul, Navi Mumbai, Maharashtra
DY Patil Hospital, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA
400706
India 
Phone  8320138364  
Fax    
Email  suyoggoswami1112@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prashant Purkar 
Designation  Professor and head of unit 
Affiliation  DY Patil Medical College 
Address  3rd floor, Department of General Medicine, DY Patil Hospital, Nerul, Navi Mumbai, Maharashtra
DY Patil Hospital, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA
400706
India 
Phone  9892971979  
Fax    
Email  prashpurkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Suyog Goswami 
Designation  Junior Resident 
Affiliation  DY Patil Medical College 
Address  3rd floor, Department of General Medicine, DY Patil Hospital, Nerul, Navi Mumbai, Maharashtra
DY Patil Hospital, Nerul, Navi Mumbai, Maharashtra 400706

MAHARASHTRA
400706
India 
Phone  8320138364  
Fax    
Email  suyoggoswami1112@gmail.com  
 
Source of Monetary or Material Support  
DY PATIL HOSPITAL, NERUL, MAHARASHTRA 400706 
 
Primary Sponsor  
Name  Dr Suyog Goswami 
Address  3rd floor, Department of General Medicine, DY Patil Hospital, Nerul, Navi Mumbai, Maharashtra  
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suyog Goswami  DY Patil Hospital  DY Patil Hospital, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA 
8320138364

suyoggoswami1112@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee for biomedical and health research DY Patil School of Medicine Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I48||Atrial fibrillation and flutter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Presenting with Atrial Fibrillation  
 
ExclusionCriteria 
Details  Patients with an implanted pacemaker.
Patients who did not give consent for the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study etiopathology of atrial fibrillation   1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To identify risk factors and preventive measures for atrial fibrillation.  1 year 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   28/07/2025 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Atrial fibrillation is a condition in which there is disorganized, irregular and rapid activation of the atria, resulting in the loss of atrial contraction. This leads to an irregular ventricular rate, which is dictated by the conduction between the atria and the ventricles. Atrial fibrillation is the prevailing heart arrhythmia in clinical practice. The incidence and prevalence of AF is becoming more common worldwide. According to statistics from the Framingham Heart Study (FHS), the occurrence of atrial fibrillation has tripled in the past 50 years. In 2016, the Global Burden of Disease project calculated that there were approximately 46.3 million people worldwide who had atrial fibrillation. Palpitations, a perception of rapid or irregular heartbeat, are the prevailing symptom in those experiencing intermittent atrial fibrillation. This may cause significant anxiety in certain individuals. AF can manifest in a range of clinical presentations, from asymptomatic cases with a fast heart rate to severe conditions like cardiogenic shock or a severe stroke. Atrial fibrillation can occur as a complication of any heart illnesses and may also be present without any evident underlying conditions. The etiologic factors include rheumatic heart diseases, ischaemic heart diseases (IHD) with acute myocardial infarction, hypertensive heart disorders, thyrotoxicosis, and cardiomyopathies. Additional infrequently encountered factors include congenital heart illnesses such as ASD, atrial dilatation resulting from myocarditis or pulmonary embolism, acute pericarditis, pericardial constriction, COPD, and old age. The clinical risk factors for AF encompass factors such as increasing age, diabetes, hypertension, congestive heart failure, rheumatic and non rheumatic valve disease, and myocardial infarction. The echocardiographic risk factors associated with non-rheumatic atrial fibrillation (AF) include expansion of the left atrium, thickening of the left ventricular wall, and a decrease in left ventricular fractional shortening. Atrial fibrillation (AF) is an independent and significant risk factor for stroke, leading to a risk that is approximately 3 to 5 times higher than normal. In addition, whereas the risks attributed to most stroke risk factors decrease as people become older, the risks attributed to stroke related with AF significantly increase with age. These chances go from 1.5% for individuals aged 50 to 59, to 23.5% for those aged 80 to 89. Several observations suggest that the burden of AF might be expected to rise. The population is aging, and the incidence of AF increases with advancing age. This study aims to identify and explain etiological factors associated with atrial fibrillation.

 
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