| CTRI Number |
CTRI/2024/08/072145 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of acute myocardial infarction in women |
|
Scientific Title of Study
|
A Clinical Profile of Acute Myocardial Infarction in Females |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Narra Rachana |
| Designation |
Junior Resident, Department of General medicine |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Medical college, Tiger circle Road, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9573921254 |
| Fax |
|
| Email |
NARRARACHANA8@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramamoorthi |
| Designation |
Associate proffessor of medicine |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Medical college, Tiger circle Road, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9449615194 |
| Fax |
|
| Email |
RMOORTHI414@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya pai |
| Designation |
Assistant proffessor of medicine |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Medical college, Tiger circle Road, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8618358714 |
| Fax |
|
| Email |
DIVYA.DP@MANIPAL.EDU |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital,Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka, India 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Narra Rachana |
| Address |
Kasturba Medical College, Tiger circle road, Madhav 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 Narra Rachana |
Kasturba Hospital, Manipal |
Opd and wards of Department of medicine, cardiology, second floor, Kasturba Hospital, Manipal, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
9573921254
NARRARACHANA8@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital | Institutional Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I20-I25||Ischemic heart diseases, |
|
|
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 |
Female |
| Details |
Patients above 18 years admitted in the hospital with diagnosis of acute myocardial infarction are included in the study |
|
| ExclusionCriteria |
| Details |
Patients below 18 years of age
Patients not consenting to the study
Patients with gross congenital cardiac anomalies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Studying the clinical profile of acute myocardial infarction in females analyze risk factors, biochemical parameters and assessing the in-hospital outcome. |
At the time of recruitment and during hospital course, at discharge. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
16/08/2024 |
| 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="6"
Days="1" |
|
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
|
Need for the study: In the recent years, there is a rise in incidence of myocardial infarction in females and not many studies have been done pertaining to it. In the modernised era, new emerging risk factors are not taken into account in the few studies that have been done. Detailed description of procedure / processes: Following admission, After the diagnosis of Acute Myocardial Infarction is made based on history, clinical examination, ECG, elevation of cardiac enzymes, - Patient’s Consent will be taken. If the patient is severely ill, consent will be obtained from patient’s attenders.
- Detailed history based on proforma - including mode of clinical presentation, risk factors and other significant history will be taken.
- Biochemical investigations will be done and recorded, coronary angiography profiles will be taken into account if done.
- The risk factors, clinical presentations, investigations will be correlated and analysed. o In hospital Outcomes will be followed.
|