| CTRI Number |
CTRI/2020/01/022663 [Registered on: 08/01/2020] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A prospective, Single-Centre study to investigate the plaque characteristics and natural history of lesions in the culprit vessels in young Indian patients |
|
Scientific Title of Study
|
Morphological Characterization of Plaques in very Young Indian ACS Patients by OCT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Girish M P |
| Designation |
Professor |
| Affiliation |
G B Pant Hospital |
| Address |
Room No.-125, Academic Block, 1st floor, Gate No. 2, G B Pant Hospital,
Jawahar Lal Nehru Marg,
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
mpgirish_1999@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Girish M P |
| Designation |
Professor |
| Affiliation |
G B Pant Hospital |
| Address |
Room No.-125, Academic Block, 1st floor, Gate No. 2, G B Pant Hospital,
Jawahar Lal Nehru Marg,
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
mpgirish_1999@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Girish M P |
| Designation |
Professor |
| Affiliation |
G B Pant Hospital |
| Address |
Room No.-125, Academic Block, 1st floor, Gate No. 2, G B Pant Hospital,
Jawahar Lal Nehru Marg,
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
mpgirish_1999@yahoo.com |
|
|
Source of Monetary or Material Support
|
| St Jude Medical India Pvt Ltd, 1-11-250/A, Matarani Sensation Building, Lane Besides Syndicate Bank, Begumpet, HYDERABAD, INDIA 500016
|
|
|
Primary Sponsor
|
| Name |
Dr Girish M P |
| Address |
Room No.-125,Academic Block,1st floor,Gate No. 2, G B Pant Hospital,Jawahar Lal Nehru Marg,New Delhi-110002 |
| 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 Girish M P |
G B Pant Hospital |
Room No.-125,Academic Block, 1st floor,Gate No. 2, G B Pant Hospital, Jawaharlal Nehru Marg, 64 Khamba, Raj Ghat, New Delhi, Delhi 110002
New Delhi
DELHI |
01123233001
mpgirish_1999@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MAMC MAULANA AZAD MEDICAL COLLEGE |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient is ≥ 18 and ≤ 35 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 chronic renal failure with a serum creatinine level of 2.0 mg/dL or more at presentation (non-HD patients)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
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)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/01/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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). The benefits of primary percutaneous
coronary intervention (primary PCI) in the treatment of ACS have been
established
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), 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 & follow-up by OCT analysis (if possible). This
information will be correlated with the follow clinical data in these patients
undergoing PCI for ACS in young Indian patients. |