| CTRI Number |
CTRI/2024/05/067898 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Use of an Atherogenic index of plasma to correlate with severity of obstruction in blood vessels of the heart in patients with Acute Coronary Syndrome |
|
Scientific Title of Study
|
Correlation of Atherogenic Index of Plasma with Stenosis level of Coronary Artery in Acute Coronary Syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunkara Divya Venkata Sagar |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba hospital, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8897371243 |
| Fax |
|
| Email |
sunkara.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MMukhyaprana Prabhu |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba hospital, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9449592986 |
| Fax |
|
| Email |
mm.prabhu@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr MMukhyaprana Prabhu |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba hospital, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9449592986 |
| Fax |
|
| Email |
mm.prabhu@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of General Medicine, Kasturba Hospital, Manipal,576104,INDIA |
|
|
Primary Sponsor
|
| Name |
Department of General Medicine Kasturba HospitalMAHE ManipalINDIA |
| Address |
Department of General Medicine, Kasturba Hospital, MAHE, Manipal, 576104, INDIA |
| Type of Sponsor |
Private medical college |
|
|
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 Sunkara Divya Venkata Sagar |
Kasturba Hospital Manipal |
Department of General Medicine, Kasturba hospital, Manipal
Udupi
KARNATAKA |
8897371243
sunkara.kmcmpl2023@learner.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 - Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I22||Subsequent ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL Observational study |
NIL Observational study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Adults above the age of (18 )years of age, posted for coronary angiogram for suspected ischemic heart disease(acute coronary syndrome) at Kasturba hospital, Manipal. |
|
| ExclusionCriteria |
| Details |
1 Patients below (18) years of age
2 History of percutaneous transluminal coronary angioplasty/coronary artery bypass graft
3 Chronic liver Disease
4 Chronic Kidney Disease
5 History of Stroke
6 Patients with RVD
7 Autoimmune disease
8 Patients with malignancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Correlation between Atherogenic Index of Plasma to severity of CAD in patients undergoing coronary angiogram.
To study the clinical and metabolic profile of patients with coronary artery disease.
|
Outcome will be assessed at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Study the clinical and metabolic profile of patients with coronary artery disease |
cross-sectional study |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
03/06/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
AIM- To evaluate the role of the AIP in Acute coronary Syndrome and correlate with stenosis of coronary artery.
Objectives: -To correlate AIP with severity of coronary artery disease as assessed by extent of stenosis in coronary angiogram and number of vessels involved. -To study clinical and metabolic profile of patients with coronary artery disease.
Description of procegure: Based on the results of coronary angiography, 2 groups will be established. - Patients In CAD Significant group will be defined as those having angiographic coronary stenosis of at least >= 50% lumen reduction in at least one major coronary artery -Patients with luminal stenosis but less than <50% will be defined as CAD insignificant group.
AIP will be calculated for both the groups by using the equation- log [Triglyceride]/[HDL cholesterol] Outcomes will be classified as following: low risk: AIP<0.11, Intermediate Risk: AIP= 0.11-0.21, High Risk: AIP> 0.21 Outcomes will be correlated with % of stenosis and number of vessels involved to assess the severity. |