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
- 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
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
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
Name Time Method 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
Name Time Method 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