| CTRI Number |
CTRI/2025/09/094143 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding transport choices of heart attack patients coming to hospital in India |
|
Scientific Title of Study
|
Factors influencing Emergency Medical Services utilization in Acute Coronary Syndrome patients at a tertiary care hospital in South 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 |
Athungro Yanthan |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
LH9 6th floor
Department of Emergency Medical Technology
Manipal College of Health Professions
Madhav Nagar
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9366848517 |
| Fax |
|
| Email |
Athungro.mchmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prithvishree Ravindra |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College and Kasturba Hospital |
| Address |
Department of Emergency Medicine Kasturba Medical College and Kasturba Hospital
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9035296971 |
| Fax |
|
| Email |
prithvishree.r@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prithvishree Ravindra |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College and Kasturba Hospital |
| Address |
Department of Emergency Medicine Kasturba Medical College and Kasturba Hospital
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9035296971 |
| Fax |
|
| Email |
prithvishree.r@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Emergency Medicine ,Kasturba Medical College, MAHE,Madhav Nagar,Manipal,Karnataka,India,576104 |
|
|
Primary Sponsor
|
| Name |
Athungro Yanthan |
| Address |
Department of Emergency Medical Technology, Manipal College of Health Professions ,Madhava Nagar, Manipal,Karnataka,576104 |
| Type of Sponsor |
Other [self] |
|
|
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 Prithvishree Ravindra |
Kasturba Hospital , Manipal |
Department of Emergency Medicine, Red area /Priority 2 , Ground floor , Kasturba Medical College and Hospital,MAHE ,Opposite Canara Mall, Madhavnagar, Manipal, Udupi, Karnataka- 576104
Udupi
KARNATAKA |
9035296971
Prithvishree.r@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed as Acute coronary syndrome in the Emergency Department
Age more than 18 years age
Both male and female |
|
| ExclusionCriteria |
| Details |
Patients/ legally acceptable representatives unavailable for an interview within 48 hours of presentation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of Ambulance usage among patients with ACS |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Factors that influence or affect Ambulance use |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="379"
Sample Size from India="379"
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)
|
15/09/2025 |
| 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="0"
Months="8"
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
|
The study will be conducted after obtaining IRC , IEC approval and CTRI registration,It is a mixed-method hospital based observational study that aims to identify and understand the factors affecting the utilization of emergency medical services (EMS) among patients presenting with acute coronary syndrome (ACS) to a tertiary care hospital in South India. The study will begin with a qualitative phase involving patient interviews to identify perceived barriers and decision making processes related to EMS use. Findings from this phase will be used to develop and validate a structured questionnaire for the quantitative phase, which will be administered to a larger sample of ACS patients. Rate of utilization of ambulance services will be studied. Factors affecting the ambulance utilization will be analysed. |