A prospective, Single-Centre study to investigate the plaque characteristics of lesions in young Indian patients of =40 years

Not Applicable

Conditions: Health Condition 1: I248- Other forms of acute ischemic heart disease

Registration Number: CTRI/2024/01/061165

Lead Sponsor: Dr Nityanand Tripathi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

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 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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plaque CharacteristicsTimepoint: Baseline and 1 year

Secondary Outcome Measures

Name	Time	Method
Incidence of MACE, a composite of Cardiac <br/ ><br>Death, MI or re-hospitalization for progressive <br/ ><br>anginaTimepoint: Day 30, 6 and 12 months