| CTRI Number |
CTRI/2025/02/081254 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
longitudinal |
| Study Design |
Other |
|
Public Title of Study
|
A study assessing how body weight, blood fat and sugar levels are linked to slow blood flow in the arteries of patients having a heart attack and getting treatment to unblock those arteries |
|
Scientific Title of Study
|
Assessment of triglyceride glucose BMI index with respect to coronary slow flow phenomenon in patients with acute myocardial infarction undergoing primary coronary intervention |
| 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 Kotharu Sai Sindhu |
| Designation |
Junior Resident ,Department of Medicine |
| Affiliation |
Kasturba Medical College,Manipal |
| Address |
Department of General Medicine,
Kasturba Medical College,
Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8500525522 |
| Fax |
|
| Email |
saisindhu128@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ananthakrishna Shastry |
| Designation |
Professor and Head of unit, Medicine 13 |
| Affiliation |
Kasturba Medical College ,Manipal |
| Address |
Department of General Medicine,
Kasturba Medical College,
Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845702450 |
| Fax |
|
| Email |
shastryba@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ananthakrishna Shastry |
| Designation |
Professor and Head of unit, Medicine 13 |
| Affiliation |
Kasturba Medical College,Manipal |
| Address |
Department of General Medicine,
Kasturba Medical College,
Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845702450 |
| Fax |
|
| Email |
shastryba@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of General Medicine |
| Address |
Kasturba Medical College,
Madhav Nagar, Manipal |
| 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 |
| Kotharu Sai Sindhu |
Kasturba Hospital,Manipal |
Department of General Medicine
Department of Cardiology,
Kasturba Hospital, Manipal
Udupi
KARNATAKA |
8500525522
saisindhu128@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-Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I21||Acute myocardial infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients of STEMI managed by PPCI and receiving the standard of care will be included in the study
The diagnosis of STEMI established according to the universal definition of myocardial infarction as
Typical rise of biochemical markers of myocardial necrosis with atleast one of the following
1)ischemic symptoms as chestpain or discomfort more than 20mins with in less than 24 hrs
2)ECG changes indicative of ischemia :new ST elevation at the J point in two contiguous leads
3)New onset LBBB
4)Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality |
|
| ExclusionCriteria |
| Details |
1)Patients on triglyceride lowering medications
2)History of Acute Myocardial infarction ,CABG or PCI
3)Valvular heart disease
4)Cardiomyopathy
5)Acute or chronic infection
6)Taking glucocorticoid therapy at the time of admission
7)Severe kidney and liver insufficiency (transaminase greater than or equal to two times the normal value ,GFR less than 15 ) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the relationship between triglyceride levels, glucose levels, and BMI with the coronary slow flow phenomenon in patients with acute myocardial infarction and are receiving primary coronary intervention. |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| study the association of triglyceride glucose BMI index with respect to coronary slow flow phenomenon |
1.5 years |
|
|
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)
|
06/03/2025 |
| 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="4"
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
|
This observational study aims to asses the association of triglyceride glucose BMI with coronary slow flow phenomenon in patients with acute myocardial infarction undergoing PPCI . All patients will undergo ECG examination, and only those with acute myocardial infarction undergoing PCI will be included. Clinical and electrocardiographic assessments will be made, including risk factors, vital signs, and presenting complaints. Laboratory tests (fasting glucose, total cholesterol, triglycerides, HDL-C, LDL-C) will be done using fasting blood samples. The TYG-BMI index will be calculated as [plasma triglycerides x fasting glucose / 2] x BMI. Diagnostic coronary angiography will identify the culprit vessel, TIMI flow, and thrombus burden. Angiographic thrombus burden will be classified by TIMI grades. 50 patients with TIMI less than ,equal to 2 and 50 with TIMI = 3 will be analyzed based on TYG-BMI. Patient management will follow standard care without intervention from the investigators. |