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

Not Applicable

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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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