| CTRI Number |
CTRI/2024/01/061165 [Registered on: 05/01/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Investigator Initiated Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A prospective, Single-Centre study to investigate the plaque characteristics of lesions in young Indian patients of ≤40 years |
|
Scientific Title of Study
|
A prospective, Single-Centre study to investigate the plaque characteristics in the culprit vessels in young Indian patients (≥18 - ≤40 yrs) with ACS undergoing PCI by Optical Coherence Tomography imaging. |
| Trial Acronym |
YPS40 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nityanand Tripathi |
| Designation |
Director and Head |
| Affiliation |
Fortis Hospital, Shalimar Bagh |
| Address |
Cardiology and Electrophysiology,
Shaheed Udham Singh Marg, A Block, Poorbi Shalimar Bag
New Delhi
DELHI
110088
India |
| Phone |
9971365522 |
| Fax |
911145302211 |
| Email |
Tripathinityanand@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nityanand Tripathi |
| Designation |
Director and Head |
| Affiliation |
Fortis Hospital, Shalimar Bagh |
| Address |
Cardiology and Electrophysiology, Shaheed Udham Singh Marg, A Block, Poorbi Shalimar Bag
New Delhi
DELHI
110088
India |
| Phone |
9971365522 |
| Fax |
911145302211 |
| Email |
Tripathinityanand@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nityanand Tripathi |
| Designation |
Director and Head |
| Affiliation |
Fortis Hospital, Shalimar Bagh |
| Address |
Cardiology and Electrophysiology, Shaheed Udham Singh Marg, A Block, Poorbi Shalimar Bag
New Delhi
DELHI
110088
India |
| Phone |
9971365522 |
| Fax |
911145302211 |
| Email |
Tripathinityanand@gmail.com |
|
|
Source of Monetary or Material Support
|
| Investigator Initiated Study
(Dr Nityanand Tripathi
Director and Head, Cardiology and Electrophysiology, Fortis Hospital, Shalimar Bagh) |
|
|
Primary Sponsor
|
| Name |
Dr Nityanand Tripathi |
| Address |
Fortis Hospital, Shalimar Bagh, Cardiology and Electrophysiology, Shaheed Udham Singh Marg, A Block, Poorbi Shalimar Bag, NEW DELHI - 110088 |
| 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 Nityanand Tripathi |
Fortis Hospital, Shalimar Bagh |
Director and Head, Cardiology and Electrophysiology,
Shaheed Udham Singh Marg, AA Block, Poorbi Shalimar Bag
New Delhi
DELHI |
9971365522
911145302211
Tripathinityanand@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Fortis Hospital, Shalimar Bagh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I248||Other forms of acute ischemic heart disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient is ≥ 18 and ≤ 40 years of age and going for PCI of the culprit lesion (more than 90 % diameter stenosis)
2. At least ≥1 de novo lesions in a native coronary segment with a visually estimated diameter stenosis between ≥ 40 % and < 90%
3. Patient has documented ACS (unstable angina, NSTEMI or STEMI within the previous 72 hours)
4. Patient demonstrates a left ventricular ejection fraction (LVEF) of ≥ 40% as measured prior to enrolment
5. Patient understands and agrees to comply with all specified study requirements and provides written Informed Consent to this effect |
|
| ExclusionCriteria |
| Details |
1) Patients with a medical condition that limits the life expectancy to 1 years or less
2) Patients scheduled to undergo surgery within 3 months that requires interruption of DAPT
3) Women who are pregnant or planning to be pregnant
4) Patients with allergy to contrast agents
5) Patients with coronary artery occlusion occurring at a site where a stent has already been placed or in whom observation by OCT is considered difficult
6) Patients in shock
7) Patients with a history of adverse reactions to aspirin, clopidogrel, or prasugrel
8) Patients who are ineligible for the study in the opinion of the investigator
9) Patients in whom follow-up at 12 months after the index procedure is considered difficult
10) Patients with renal failure with a serum creatinine level of 2.0 mg/dL or more at presentation (non-HD patients)
11) Patients with active heart failure
12) Patients with acute Mitral regurgitation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Plaque Characteristics |
Baseline and 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of MACE, a composite of Cardiac
Death, MI or re-hospitalization for progressive
angina |
Day 30, 6 and 12 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
05/12/2025 |
| 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="4"
Months="0"
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
|
Acute coronary syndrome (ACS) is characterized by rapid stenosis or occlusion of the lumen caused by coronary thrombus formation, resulting in myocardial ischemia or necrosis. It is classified into ST-elevation acute myocardial infarction (STEMI), non-ST-elevation acute myocardial infarction (NSTEMI), and unstable angina (UA). Coronary plaques in ACS are greatly different from those in stable coronary artery disease (SCAD), being characterized by various morphological features and thrombus formation within the coronary artery. Culprit lesions of ACS can be identified as occluded or severely stenotic lesions on a coronary angiogram, but non-culprit lesions that are angiographically shown to be mildly or moderately stenotic also often represent lipid or vulnerable plaques with a necrotic core, suggesting that they are likely to lead to thrombus formation.
Recent advances in intravascular imaging techniques such as intravascular ultrasound (IVUS) and optical coherence tomography (OCT) have made it possible to assess coronary lesions in greater detail. OCT is an imaging technique that employs near-infrared light with a wavelength of about 1300 nm emitted from the tip and visualizes the vascular lumen based on the light reflected from various parts of the lumen. Because of its high resolution (10 to 15 μm), optical coherence tomography (OCT) has played an important role in elucidating the pathology of ACS by, for example, identifying thin-cap fibroatheroma (TCFA) with a large necrotic lipid core, one of the major causes of ACS, and its rupture, and characterizing coronary thrombi as red, white, or mixed thrombi based on morphology and the degree of signal attenuation
This study will evaluate the plaque characteristics (minimum lumen area, fibrous cap thickness, lipid arc extension, presence of microcalcification macrophages infiltration and microchannel formation at the explored plaques) of culprit lesions at baseline. This information will be correlated with the follow clinical data in these patients undergoing PCI for ACS in young Indian patients.
|