| CTRI Number |
CTRI/2023/09/057390 [Registered on: 11/09/2023] Trial Registered Prospectively |
| Last Modified On: |
08/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Atrial Fibrillation (an often rapid and irregular heart beat/rhythm among patients admitted in ICU |
|
Scientific Title of Study
|
Incidence, Clinical profile and Outcome of Atrial Fibrillation among critically ill patients in Tertiary Intensive Care Unit |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Niranjan K R |
| Designation |
MSc Students |
| Affiliation |
Narayana Hrudayalaya Foundation |
| Address |
Narayana Hrudayalaya Foundations
Department of Clinical Research,
Room no 1, Basement Narayana Hrudayalaya
NH Health City, 258/A Bommasandra Industrial Area, Anekal Taluk, Banglore
Bangalore
KARNATAKA
560099
India |
| Phone |
7204427014 |
| Fax |
|
| Email |
yethirajniranjan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Snehali Majumder |
| Designation |
Research Scientist and Senior Microbiologist |
| Affiliation |
Narayana Hrudayalaya Foundations |
| Address |
Narayana Hrudayalaya Foundations
Department of Clinical Research,
Room no 1, Basement Narayana Hrudayalaya
NH Health City, 258/A Bommasandra Industrial Area, Anekal Taluk, Banglore
Bangalore
KARNATAKA
560099
India |
| Phone |
9741615001 |
| Fax |
|
| Email |
snehali.majumder@narayanahealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Snehali Majumder |
| Designation |
Research Scientist and Senior Microbiologist |
| Affiliation |
Narayana Hrudayalaya Foundations |
| Address |
Narayana Hrudayalaya Foundations
Department of Clinical Research,
Room no 1, Basement Narayana Hrudayalaya
NH Health City, 258/A Bommasandra Industrial Area, Anekal Taluk, Banglore
Bangalore
KARNATAKA
560099
India |
| Phone |
9741615001 |
| Fax |
|
| Email |
snehali.majumder@narayanahealth.org |
|
|
Source of Monetary or Material Support
|
| Mazumdar Shaw Medical Centre NH Health City, 258/A, Bommasandra Industrial Area, Anekal Taluk Banglore
Bangalore
KARNATAKA |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Snehali Majumder |
Mazumdar Shaw Medical Center (A Unit of Narayana Health) |
Medical Intensive Care Unit
Second Floor
Mazumdar Shaw Medical Centre
NH Health City, 258/A, Bommasandra Industrial Area, Anekal Taluk Banglore
Bangalore
KARNATAKA |
91-9741615001
snehali.majumder@narayanahealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Health Academic Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I480||Paroxysmal atrial fibrillation, (2) ICD-10 Condition: I481||Persistent atrial fibrillation, (3) ICD-10 Condition: I482||Chronic atrial fibrillation, (4) ICD-10 Condition: I489||Unspecified atrial fibrillation and atrial flutter, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged above 18 years
Patients of both gender
1. Male
2. Female
Patient with history of AF in last 12 months |
|
| ExclusionCriteria |
| Details |
Patients participating in a clinical trial in the field of antithrombotic treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The prevalence of AF among critically ill patients
2. Incidence of new onset AF among critically ill patients
|
1. Baseline: At recruitmnet
2. Length of ICU Stay: Day wise assessment of parameters during ICU stay
3. At Discharge/Death: To assess outcome |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The correlation of AF & NOAF with patient outcome
1. Patient survived
2. Patient death |
1.Patient Survival: From patient recruitment till hospital discharge.
2. Patient Death: Time point at which patient is declared dead.
All study analyses will be carried out after all patient recruitment is completed |
| The stroke risk in New-Onset Atrial Fibrillation patients |
Date of onset of Atrial fibrillation in ICU till the discharge or death of patient. |
| The correlation of lifestyle with the development of AF |
Lifestyle parameters will be collected as per CRF after getting consent from patient or attenders. |
|
|
Target Sample Size
|
Total Sample Size="787"
Sample Size from India="787"
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)
|
18/09/2023 |
| 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
|
This will be a Prospective Observational study carried out in Medical Intensive Care Unit. Patients will be screened for ECG confirmed Atrial Fibrillation. After obtaining written Informed consent the data will be collected as per the Case report form and the patient will be monitored until their last day stay in Intensive Care Unit and observed for their outcome and progression. All statistical analysis will be carried out once all patient data will be collected. |