| CTRI Number |
CTRI/2025/09/094766 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A prospective observational study to assess the role of 18F-FDG PET-CT in evaluating myocardial inflammation immediately after Percutaneous Angioplasty with Myocardial Intervention (PAMi) in patients with coronary artery disease. |
|
Scientific Title of Study
|
A Study to assess role of 18F-FDG PET-CT immediately after PAMI in a case of coronary artery disease |
| 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 Vigneshwaran M |
| Designation |
Assistant Professor Nuclear Medicine |
| Affiliation |
INHS Asvini |
| Address |
Dept Of Nuclear Medicine
INHS Asvini, Near RC Church
Colaba
INHS Asvini, Near RC Church
Mumbai
MAHARASHTRA
400005
India |
| Phone |
8698751411 |
| Fax |
|
| Email |
waranthedon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vigneshwaran M |
| Designation |
Assistant Professor Nuclear Medicine |
| Affiliation |
INHS Asvini |
| Address |
Dept Of Nuclear Medicine
INHS Asvini, Near RC Church
Colaba
INHS Asvini, Near RC Church
Mumbai
MAHARASHTRA
400005
India |
| Phone |
8698751411 |
| Fax |
|
| Email |
waranthedon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharat S Sambyal |
| Designation |
Associate Professor, Cardiology |
| Affiliation |
INHS Asvini |
| Address |
Department of Cardiology, INHS Asvini, near RC Church, Colaba
Mumbai
MAHARASHTRA
400005
India |
| Phone |
8384031327 |
| Fax |
|
| Email |
drbharatsambyal@gmail.com |
|
|
Source of Monetary or Material Support
|
| INHS Asvini, Governmetn hospital (no external funding) |
|
|
Primary Sponsor
|
| Name |
Dr Vigneshwaran M |
| Address |
Dept of Nuclear Medicine, INHS Asvini, Colaba, Mumba-400005 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Bharat S Sambyal |
Depat of Cardiology, INHS Asvini, Mumbai -400005 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vigneshwaran M |
INHS Asvini |
Dept Of Nuclear Medicine
INHS Asvini, Near RC Church
Colaba
Mumbai
MAHARASHTRA |
8698751411
waranthedon@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INHS Asvini Ethics Committee |
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 |
Primary angioplasty in myocardial infarction |
primary angioplasty done in case of acute ST elevation myocardial infarction as for routine treatment protocol |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients who qualify for a need of diagnostic angiography followed by angioplasty
1. Acute ST-elevation myocardial infarction
2. Non ST-elevation myocardial infarction
3. Unstable angina
4. Stable angina
5. Anginal equivalent
6. High risk stress test findings
|
|
| ExclusionCriteria |
| Details |
un willing for 18F-FDG PET-CT
Pregnant women
Psychiatry patients
claustrophobic |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of Ejection fraction and reperfusion |
Improvement of Ejection fraction and reperfusion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To check for improvement in ejection fraction and reperfusion.
To correlate FDG uptake with procedural details (number of vessels involved, stent placement, and duration).
To assess association between post-PAMi inflammation and serum cardiac biomarkers (e.g., Troponin I, CK-MB, hs-CRP).
To explore predictive value of early PET-CT findings in short-term outcomes (e.g., recurrent angina, re-hospitalization within 30 days).
|
3-6 months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
30/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 prospective observational study will evaluate the role
of 18F-FDG PET-CT in detecting myocardial inflammation
immediately after Percutaneous Angioplasty with
Myocardial Intervention (PAMi) in patients with coronary
artery disease. PET-CT will be performed within 24–72
hours post-procedure and repeated at 3–6 months to assess
changes in myocardial metabolic activity.
The study aims to correlate early FDG uptake with ejection
fraction, serum biomarkers, procedural details, and short-
term outcomes such as recurrent angina or
rehospitalization. It is hypothesized that early PET-CT can
identify inflammation reflecting procedural impact and
predict recovery, with follow-up scans showing reperfusion
and improvement in cardiac function.
|