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CTRI Number  CTRI/2025/02/079859 [Registered on: 03/02/2025] Trial Registered Prospectively
Last Modified On: 28/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   A Study on Irregular Heartbeats in Patients at a Central India Hospital 
Scientific Title of Study   Clinical and epidemiological profile of atrial fibrillation in a tertiary care hospital in central INDIA. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prajakta Pramodkumar Kakde  
Designation  Junior Resident 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Medicine, Third Floor, Room Number 2, Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education & Research, Sawangi, Meghe, Wardha, India, 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9130248444  
Fax    
Email  kprajaktaltr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sourya acharya 
Designation  professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Medicine, Third Floor, Room Number 2, Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education & Research, Sawangi, Meghe, Wardha, India, 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9371454269  
Fax    
Email  souryaacharya74@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sourya acharya 
Designation  professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Medicine, Third Floor, Room Number 2, Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education & Research, Sawangi, Meghe, Wardha, India, 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9371454269  
Fax    
Email  souryaacharya74@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha, India, 442001 
 
Primary Sponsor  
Name  Datta meghe institute of higher education and researchsawangi  
Address  Department of Medicine, Third Floor, Room Number 2, Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education & Research, Sawangi, Meghe, Wardha, India, 442001 
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 
Prajakata Pramodkumar Kakde  Datta Meghe Institute of Medical Sciences Sawangi (Meghe) Wardha  Department of Medicine, Room Number 1, Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha, India, 442001
Wardha
MAHARASHTRA 
9130248444

kprajaktaltr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta meghe institute of higher education and research,sawangi   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 
Intervention  NIL  NA 
Comparator Agent  NIL  NA 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with atrial fibrillation based on clinical assessment and supported by ECG and 2D Echocardiogram.
2. Patients aged between 30 and 80 years.
3. Patients admitted to the tertiary care hospital during the study period
 
 
ExclusionCriteria 
Details  1. Patients diagnosed with other forms of tachyarrhythmias.
2. Patients with mental or physical conditions that prevent them from participating in the study.
3. Patients who are lost to follow-up or unwilling to participate in the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
determining the proportion of cases across different age groups, sexes, and etiological categories (valvular vs. non-valvular).  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
1. Symptom Profile
2. Etiological Factors
3. Pattern of Presentation
4. Risk Assessment
5. Treatment Response
6. Mortality
7. Recurrence Rates

 
2 years 
 
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)   01/03/2025 
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="2"
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  

Background: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia encountered in clinical practice and is associated with significant morbidity and mortality. Understanding AF’s clinical and epidemiological profile is crucial for effective management and risk stratification. This study aims to investigate the prevalence, symptomatology, etiological factors, and treatment outcomes of AF in a tertiary care hospital in Central India.

Material and Methods: A cross-sectional study will be conducted at a tertiary care hospital in Central India over two years. Seventy-five patients diagnosed with AF will be recruited, and demographic data, symptom profiles, etiological factors, and treatment outcomes will be systematically documented. Statistical analysis, including descriptive, bivariate, and multivariate analyses, will be performed to examine associations and trends in the data.

Expected Outcome: The study is anticipated to provide valuable insights into the clinical and epidemiological profile of AF in the study population. The findings are expected to elucidate the prevalence and distribution of AF, characterize symptom profiles, identify underlying etiological factors, and evaluate treatment responses. Additionally, the study aims to assess risk stratification using the CHADS2-VASc score and analyze secondary outcomes such as mortality, heart failure admissions, and recurrence rates. The outcomes of this study will contribute to evidence-based decision-making and improve the management of AF in clinical practice.

Keywords: Atrial fibrillation, clinical profile, epidemiology, prevalence, symptomatology, etiology, treatment outcomes, CHADS2-VASc score, Central India.

 

 

 
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