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CTRI Number  CTRI/2024/04/066276 [Registered on: 25/04/2024] Trial Registered Prospectively
Last Modified On: 07/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study of the size of the chamber of the heart and its volume in patients with a condition where heart beat is irregular 
Scientific Title of Study   Study of the left atria size and volume in patients with 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  Mohit Agarwalla 
Designation  Junior resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of General Medicine, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9113876429  
Fax    
Email  mohit.kmcmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  B Anathakrishna Shastry 
Designation  Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of General Medicine, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845702450  
Fax    
Email  ba.shastry@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  B Anathakrishna Shastry 
Designation  Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of General Medicine Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845702450  
Fax    
Email  ba.shastry@manipal.edu  
 
Source of Monetary or Material Support  
Department of Cardiology, Kasturba Medical Hospital, Madhav Nagar, Manipal Karnataka, India Pin Code - 576104 
Department of General Medicine, Kasturba Medical Hospital, Madhav Nagar, Manipal Karnataka, India Pin Code - 576104 
 
Primary Sponsor  
Name  Kasturba Medical College Department of General Medicine and Cardiology 
Address  Kasturba Medical College, Madhav Nagar, Manipal, Karnataka, India Pin - 576104 
Type of Sponsor  Private medical college 
 
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 Mohit Agarwalla  Kasturba Hospital  Room No - 16 Department of General Medicine, Room No - 31 Department of Cardiology Kasturba Hospital, Madhav Nagar, Manipal, Karnataka Pin Code - 576104
Udupi
KARNATAKA 
9113876429

mohit.kmcmpl2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-Student Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I489||Unspecified atrial fibrillation and atrial flutter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL Observational Study  NIL Observational Study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Any patient with new-onset atrial fibrillation or patients with already been diagnosed with atrial fibrillation on medications who are following up at the Department of General Medicine and Cardiology, Kasturba Hospital, Manipal


 
 
ExclusionCriteria 
Details  1. Those who do not consent to participate in the study
2. Pregnancy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study left atria size and volume using echocardiography in patients with atrial fibrillation and to compare it with various causes of atrial fibrillation


 
No Time points as it is a cross-sectional observational study
 
 
Secondary Outcome  
Outcome  TimePoints 
To classify the various causes of atrial fibrillation according to the risks of causing atrial fibrillation by measuring left atrial size & volume


 
No time points as it is a Cross-sectional observational study 
 
Target Sample Size   Total Sample Size="156"
Sample Size from India="156" 
Final Enrollment numbers achieved (Total)= "156"
Final Enrollment numbers achieved (India)="156" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/05/2024 
Date of Study Completion (India) 31/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Aim: Assessment of Left Atria size and volume in patients of atrial fibrillation 

Objectives:

  • Etiology Of Atrial Fibrillation

  • Left Atrial size and volume by echocardiography.

  • Comparing Left Atrial Sizes and volumes in various causes of Atrial Fibrillation 

  1. For the study, patients from the Department of General Medicine and Cardiology permission will be taken. Patients admitted in the Department of General Medicine and Cardiology will be recruited for the study according to the inclusion and exclusion criteria. Informed written consent of all the participants would be taken after explaining the purpose of the study and also the about the risks/benefits of the study. Information will be collected according to the proforma made by the primary investigator along with the inputs suggested by the guide and co-guide. The information that will be collected will be the demographic details of the patient (excluding the Name), History of presenting illness, relevant past medical or surgical history, current treatment history and routine general physical and clinical examination, relevant Lab data, XRAY, ECG and Routine Echocardiography, most of the laboratory data is sent as routine investigations, so extra investigations won’t be required. Since, it is a cross sectional observational study, data will be collected from the time once from the patient in the present admission only. Patient wouldn’t be called back for the study purpose.  By this study, we are assessing the LA size and LA volume and correlating it with the etiology of atrial fibrillation and assessing the prevalence of development of atrial fibrillation, so that we can identify the etiologies where there is high risk of development of atrial fibrillation, and early intervention and aggressive management can be done to prevent the complications. Also, since this is an observational study, the patient management will be chosen by the patients treating clinician without any intervention from the investigators. 


 
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