| 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
|
|
|
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
|
|
|
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 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.
|