| CTRI Number |
CTRI/2024/03/064016 [Registered on: 12/03/2024] Trial Registered Prospectively |
| Last Modified On: |
08/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The symptom-to-door time and barriers to delay in hospital arrival among patients diagnosed with myocardial infarction and their outcome observed. |
|
Scientific Title of Study
|
A descriptive study to assess the symptom-to-door time and barriers to delay in hospital arrival among patients diagnosed with myocardial infarction and their outcome observed at a selected tertiary care hospital, Udupi district. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarita Marandi |
| Designation |
Student |
| Affiliation |
Manipal college of nursing, MAHE, Manipal |
| Address |
Manipal College of Nursing, Manipal Academy of Higher Education, Tiger circle Road, Madhav Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7909002455 |
| Fax |
|
| Email |
saritamarandi.9563@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Elsa Sanatombi Devi |
| Designation |
Professor |
| Affiliation |
Manipal College of Nursing, MAHE, Manipal |
| Address |
Manipal College of Nursing, Manipal Academy of Higher Education, Tiger circle Road, Madhav Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8310769938 |
| Fax |
|
| Email |
elsa.sana@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Elsa Sanatombi Devi |
| Designation |
Professor |
| Affiliation |
Manipal College of Nursing, MAHE, Manipal |
| Address |
Manipal College of Nursing, Manipal Academy of Higher Education, Tiger circle Road, Madhav Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8310769938 |
| Fax |
|
| Email |
elsa.sana@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Sarita Marandi
Manipal College Nursing,
MAHE,
Manipal, Udupi,
Karnataka - 576104 |
|
|
Primary Sponsor
|
| Name |
Sarita Marandi |
| Address |
Manipal College Of Nursing, Manipal Academy of Higher Education, Tiger circle road, madhav nagar, udupi, Karnataka - 576101 |
| 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 Elsa Sanatombi Devi |
Kasturba Hospital |
Cardiology Unit, 2nd floor Kasturba Hospital, Manipal
Udupi
KARNATAKA |
8310769938
elsa.sana@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 |
20.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
-Physician diagnosed with myocardial infarction.
-Patients who developed myocardial infarction before admission.
-Patients who are ready to participate in the study.
-Patients who can read and speak English and Kannada
-Patients admitted in Critical Care Unit, and cardiac wards with myocardial infarction at Kasturba Hospital, Manipal.
-Patients who are not on a ventilator
-Hemodynamically stable patients after 72hours after admission.
|
|
| ExclusionCriteria |
| Details |
-Patients who are unwilling to participate in the study.
-Patients with in-hospital myocardial infarction.
-Patients who are unconscious
-Patients who are referred within 6 hours.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Symptom-to-door time |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="195"
Sample Size from India="195"
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)
|
18/03/2024 |
| 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 Applicable |
| 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 findings of the study may help in future
improvement and promptness in recognizing symptoms of MI, may help in
overcoming the barriers and spread awareness among the patients to shorten
delays to hospital. It will increase their responsiveness in seeking prompt
medical care
The hypothesis will be tested at 0.05 level of significance
•
H1: There will be significant co-relation
between the symptom-to-door
and
outcome observed among patients
diagnosed with Myocardial Infarction.
|