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

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. - YPS40

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/01/061165
Enrollment
50
Registered
2024-01-05
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: NIL: NIL

Sponsors

Dr Nityanand Tripathi
Lead Sponsor

Eligibility

Inclusion criteria

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 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

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.

Design outcomes

Primary

MeasureTime frame
Plaque CharacteristicsTimepoint: Baseline and 1 year

Secondary

MeasureTime frame
Incidence of MACE, a composite of Cardiac Death, MI or re-hospitalization for progressive anginaTimepoint: Day 30, 6 and 12 months

Countries

India

Contacts

Public ContactDr Nityanand Tripathi

Fortis Hospital, Shalimar Bagh

Tripathinityanand@gmail.com9971365522

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026