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Study to derive and understand the characteristic of plaque formation and outcome of Coronary Angioplasty in patients with acute coronary syndrome, through Intra-vascular Ultrasound

INTRAVASCULAR ULTRASOUND (IVUS) DERIVED PLAQUE CHARACTERISTICS AND OUTCOMES IN ACUTE CORONARY SYNDROME UNDERGOING PERCUTANEOUS INTERVENTION

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/09/036845
Enrollment
200
Registered
2021-09-24
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: I249- Acute ischemic heart disease, unspecified

Interventions

None listed

Sponsors

Society for Coronary Imaging and Physiology SCIP
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients who are undergoing IVUS guided PCI for diagnosis of 1) ST elevation myocardial infarction (STEMI): Defined as chest pain with > 1mm STE in 2 contigous leads except V2 & V3. In V2 & V3, STE of > 2mm in males & > 1.5mm in females 2) Non ST elevation myocardial infarction (NSTEMI): Defined as chest pain with ECG changes consistent with new ischemia ( ST depression , T inversions ) with troponin elevation 3. Unstable angina: Defined as chest pain at rest or minimal effort with or without ECG changes and no biomarker elevation

Exclusion criteria

Exclusion criteria: 1) cardiogenic shock - as defined by SBP 2) Hemodynamic instability - as defined by recurrent VT / acute pulmonary oedema / need for ventilator support / mechanical cardiac support - or any instance where operator feels performing imaging is not possible due to clinical instability 3) Stent thrombosis / restenosis - any stent failure related vessel 4) Graft interventions 5) Inability to perform either pre or post IVUS images 6) Mechanical complications 7) Planned CABG in next 30 days 8) Severe comorbidities which restrict life span to 9) Presenting eGFR 10) Age 90 years

Design outcomes

Primary

MeasureTime frame
1. TIMI flow 2 at end of procedure 2. Target lesion revascularisation at any time point ( inhospital, 30 days, 6months)Timepoint: 1. TIMI flow 2 at end of procedure 2. Target lesion revascularisation at any time point ( inhospital, 30 days, 6months)

Secondary

MeasureTime frame
Echo derived LV function ( ejection fraction)Timepoint: end of procedure, at 30 days and 6 months;Incidence of adverse eventsTimepoint: end of procedure, at 30 days and 6 months;Incidence of cardiac death, MI, target lesion revascularisation, any unplanned revascularisation and LV function (extended followup)Timepoint: at 1 year;IVUS analysis of plaque morphologyTimepoint: inhospital, 30 days & 6 months;MACE (cardiac death, MI and need for repeat target lesion revascularisation ( TLR), any unplanned revascualrisation)Timepoint: inhospital, 30 days & 6 months

Countries

India

Contacts

Public ContactDr Sajan Narayanan MD DM

Little Flower Hospital and Research Institute

drsajannarayanan2021@gmail.com8086842627

Outcome results

None listed

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