| 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
|
|
|
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
|
|
|
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.
|