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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

Not Applicable
Conditions
Health Condition 1: I249- Acute ischemic heart disease, unspecified
Registration Number
CTRI/2021/09/036845
Lead Sponsor
Society for Coronary Imaging and Physiology SCIP
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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

1)cardiogenic shock - as defined by SBP < 90mmHg (/ need for inotropic support to maintain perfusion ) + evidence of end organ hypoperfusion - altered sensorium / oliguria

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 < 1 year

9)Presenting eGFR < 30 ml/min/m2

10)Age < 18 & >90 years

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. TIMI flow 2 at end of procedure <br/ ><br> <br/ ><br>2. Target lesion revascularisation at any time point ( inhospital, 30 days, 6months)Timepoint: 1. TIMI flow 2 at end of procedure <br/ ><br> <br/ ><br>2. Target lesion revascularisation at any time point ( inhospital, 30 days, 6months)
Secondary Outcome Measures
NameTimeMethod
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
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