| CTRI Number |
CTRI/2021/09/036435 [Registered on: 13/09/2021] Trial Registered Prospectively |
| Last Modified On: |
13/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study Of Inferior Wall Myocardial Infarction and Right Ventricular Wall Myocardial Infarction |
|
Scientific Title of Study
|
The Clinical Profile of Inferior Wall Myocardial Infarction and Right Ventricular Myocardial Infarction. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya Arora |
| Designation |
1st year Medicine Resident |
| Affiliation |
Government Medical College, Bhavnagar. |
| Address |
flat no.25, PG1 hostel, Sir T hospital Campus, Bhavnagar.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9586628643 |
| Fax |
|
| Email |
div893arora@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ila N Hadiyel |
| Designation |
Associate Professor in Department of Medicine |
| Affiliation |
Government Medical College, Bhavnagar. |
| Address |
Flat no; A-102, sumeru arts, Rupani Circle Bhavnagar-364003, Gujarat
Bhavnagar
GUJARAT
364003
India |
| Phone |
9825315890 |
| Fax |
|
| Email |
dr.ilahadiyel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Arora |
| Designation |
1st year Medicine Resident |
| Affiliation |
Government Medical College, Bhavnagar. |
| Address |
flat no.25, PG1 hostel, Sir T hospital Campus, Bhavnagar.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9586628643 |
| Fax |
|
| Email |
div893arora@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Divya Arora |
| Address |
flat no.25, PG1 hostel, Sir T hospital campus, Bhavnagar. |
| 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 Divya Arora |
Government Medical College, Bhavnagar |
Medicine Department, above burns ward, ICCU ward.
Bhavnagar
GUJARAT |
9586628643
div893arora@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I211||ST elevation (STEMI) myocardial infarction of inferior wall, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All Patients with clinical symptoms of ischaemic type discomfort and ECG changes diagnosing of Inferior wall Myocardial Infarction and Right Ventricular Wall Myocardial Infarction.
|
|
| ExclusionCriteria |
| Details |
Past History of Myocardial Infarction.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To study various clinical presentation of Inferior Wall Myocardial Infarction and Right Ventricular Wall Myocardial Infarction.
|
24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the acute complications and mortality rate of Inferior Wall Myocardial Infarction with or without Right ventricular Myocardial Infarction.
2.To estimate the occurrence of Right ventricular infarction in patient of Inferior Wall Myocardial Infarction.
|
1-5 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/09/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Prior Permission from Ethics Committee of Government medical College, Bhavnagar will be taken Participants suitable for study( IWMI & IWMI+RVMI) will be selected according to inclusion and exclusion criteria Written Informed consent will be taken from patient or patient’s relative Detailed history and clinical examination will be done Blood Pressure, Heart Rate and SpO2 Monitoringwill be done according to standard Procedures and Protocols. Serial Electrocardiograms will be done Data will be entered in Case Record Form and Masterchart. |