| CTRI Number |
CTRI/2021/09/036155 [Registered on: 02/09/2021] Trial Registered Prospectively |
| Last Modified On: |
27/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation of inflammation with atherosclerosis in acute myocardial Infarction |
|
Scientific Title of Study
|
Correlation of C-Reactive Protein with Atherognic Index of Plasma in Acute 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 Mahima Khandige |
| Designation |
Junior Resident |
| Affiliation |
Father Muller Medical College Hospital |
| Address |
Father Muller Medical College
Department of General medicine
Kankanady Mangaluru
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
8762022074 |
| Fax |
|
| Email |
mahima96khandige@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akshatha Rao Aroor |
| Designation |
Associate professor |
| Affiliation |
Father Muller Medical College Hospital |
| Address |
Father Muller Medical College
Department of General medicine
Kankanady Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9449205808 |
| Fax |
|
| Email |
akshatharao0502@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahima Khandige |
| Designation |
Junior Resident |
| Affiliation |
Father Muller Medical College Hospital |
| Address |
Father Muller Medical College
Kankanady Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8762022074 |
| Fax |
|
| Email |
mahima96khandige@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College Hospital, Kankanady, Mangalore, 575002 |
|
|
Primary Sponsor
|
| Name |
Dr Mahima Khandige |
| Address |
Father Muller Medical College Kankanady Mangaluru |
| Type of Sponsor |
Other [Self funding] |
|
|
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 Mahima Khandige |
Father Muller Medical College Hospital |
Department of general medicine 6th floor
Kankanady Mangaluru
575002
Dakshina Kannada
KARNATAKA |
8762022074
mahima96khandige@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller 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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients aged 18 years and above diagnosed to have acute myocardial infarction as per AHA/ACCA guidelines |
|
| ExclusionCriteria |
| Details |
Patients with diagnosed chronic infections like tuberculosis, connective tissue disorders, malignancy, autoimmune conditions
Patients with history of major trauma or surgery in the past 3 months, ptaients with acute kidney injury, chronic kidney disease, pulmonary embolism, myocarditis
Patients on lipid lowering agents |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To estimate CRP in patients with acute myocardial infarction
2. To estimate the lipid profile in patients with acute myocardial infarction
|
Baseline at time of admission
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the correlation of CRP with Atherognic Index of Plasma in patients with acute myocardial infarction |
At the end of the study, correlation will be assessed |
|
|
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)
|
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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Coronary heart disease is one of the leading causes of morbidity and mortality in the world. Studies have shown that inflammation and atherosclerosis both have their own parts to play in the pathogenesis of myocardial infarction. CRP is a marker of inflammation and Atherogenic index of plasma a marker of atherosclerosis as the name suggests. This study aims to correlate atherosclerosis and inflammation in patients with Acute Myocardial Infarction. |