| 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
|
|
|
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
|
|
|
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. |