A prospective, Single-Centre study to investigate the plaque characteristics and natural history of lesions in the culprit vessels in young Indian patients

Recruiting

• Conditions: Other forms of acute ischemic heart disease,

• Registration Number: CTRI/2020/01/022663
• Lead Sponsor: Dr Girish M P

Brief Summary

Acute coronary syndrome (ACS) is characterized by rapid stenosis orocclusion of the lumen caused by coronary thrombus formation, resulting inmyocardial ischemia or necrosis. It is classified into ST-elevation acutemyocardial infarction (STEMI), non-ST-elevation acute myocardial infarction(NSTEMI), and unstable angina (UA). The benefits of primary percutaneouscoronary intervention (primary PCI) in the treatment of ACS have beenestablished

Coronary plaques in ACS are greatlydifferent from those in stable coronary artery disease (SCAD), beingcharacterized by various morphological features and thrombus formation withinthe coronary artery. Culprit lesions of ACS can be identified as occluded orseverely stenotic lesions on a coronary angiogram, but non-culprit lesions thatare angiographically shown to be mildly or moderately stenotic also oftenrepresent lipid or vulnerable plaques with a necrotic core, suggesting thatthey are likely to lead to thrombus formation.

Recent advances in intravascularimaging techniques such as intravascular ultrasound (IVUS) and opticalcoherence tomography (OCT) have made it possible to assess coronary lesions ingreater detail. OCT is an imaging technique that employs near-infrared lightwith a wavelength of about 1300 nm emitted from the tip and visualizes thevascular 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 rolein elucidating the pathology of ACS by, for example, identifying thin-capfibroatheroma (TCFA) with a large necrotic lipid core, one of the major causesof ACS, and its rupture, and characterizing coronary thrombi as red, white, ormixed 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 microcalcificationmacrophages infiltration and microchannel formation at the explored plaques) ofculprit lesions at baseline & follow-up by OCT analysis (if possible). Thisinformation will be correlated with the follow clinical data in these patientsundergoing PCI for ACS in young Indian patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-16
• Last Update Posted: 2021-02-27

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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.

Exclusion Criteria

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).

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plaque Characteristics	Baseline and 1 year

Secondary Outcome Measures

Name	Time	Method
Incidence of MACE, a composite of Cardiac Death, MI or re-hospitalization for progressive angina	Day 30, 6 and 12 months

Trial Locations

Locations (1)

G B Pant Hospital; 🇮🇳 Delhi, DELHI, India

G B Pant Hospital

🇮🇳Delhi, DELHI, India

Dr Girish M P

Principal investigator

01123233001

mpgirish_1999@yahoo.com