Intravascular ULTRAsound-Guided PCI in Patients With ST-Elevation Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
The main goal of the ULTRA-STEMI trial is to investigate the prognostic impact of IVUS-guided PCI in patients with STEMI and correlate IVUS measurements with clinical, procedural, imaging and follow-up outcomes of interest. Study participants will undergo primary PCI as per standardized procedures; IVUS will be performed at baseline, post-intervention and post-optimization. Manual thrombus aspiration will be performed according to clinical indications. The aspirated thrombi will be collected and scanned with micro-computed tomography (micro-CT). Also, angiographic and peri-procedural data will be gathered. Post-PCI instantaneous wave-free ratio (IFR) will also be performed to assess the severity of the residual coronary-artery stenosis, if any. All patients will be followed up for at least12 months for the adjudication of major adverse cardiovascular events.

Detailed Description
-----------------
The ULTRA-STEMI trial is a prospective investigator-initiated single-centre single-arm observational cohort study aiming to enroll 80 consecutive patients presenting with ST-segment elevation myocardial infarction (STEMI) and undergoing IVUS-guided primary PCI. IVUS will be performed at baseline, post-intervention and post-optimization. Baseline tissue characterization includes the morphological description of culprit lesion plaque and thrombus characteristics as assessed with IVUS. In patients with large thrombus burden, manual thrombus aspiration will be performed according to clinical indications. The aspirated thrombi will be collected and scanned with micro-computed tomography (micro-CT) to correlate IVUS measurements with micro-CT thrombus quantification. Also, angiographic data will be gathered to correlate IVUS measurements with pre-and post-PCI angiographic information. Post-PCI instantaneous wave-free ratio (IFR) will also be performed to assess the severity of the residual coronary-artery stenosis, if any. All patients will be followed up for at least 12 months for the adjudication of major adverse cardiovascular events.The primary endpoint will be target vessel failure at 12 months (defined as a composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization). The secondary outcomes of interest will be: radiation exposure, contrast use and kidney function effects. Other endpoints include clinical and angiographic outcomes along with post-PCI IVUS, iFR and micro-CT findings.

Official Title
-----------------
Intravascular ULTRAsound-Guided PCI in Patients With ST-Elevation Myocardial Infarction: the ULTRA-STEMI Trial

Conditions
-----------------
STEMI, Intravascular Imaging, IVUS

Intervention / Treatment
-----------------
* Device: IVUS imaging for primary PCI guidance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute STEMI undergoing primary PCI within 12 hours of symptom onset according to the 4th universal definition of myocardial infarction. Age >18 years Individuals willing to voluntarily sign the consent and data protection forms before their inclusion in the clinical study. Exclusion Criteria: Patients presenting with cardiogenic shock Patients with a known contraindication for primary PCI Pregnancy Presentation ≥12 hours after symptom onset

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with STEMI undergoing IVUS-guided primary PCI<br>The ULTRA-STEMI trial will include consecutive patients with STEMI undergoing IVUS-guided primary PCI. All participants will undergo: IVUS intra-coronary imaging at baseline-, post-intervention and post-optimization. If manual thrombus aspiration is needed, the aspirated thrombotic material will be collected to be micro-CT scanned. Post-PCI iFR will be also performed in each participant. Clinical, angiographic and peri-procedural data will be collected. Each participant will be subject to telephone follow-up at 1, 6 and 12 months. | Device: IVUS imaging for primary PCI guidance<br>* Eagle Eye Platinum Intravascular ultrasound (IVUS) will be used to assess intra-coronary plaque, thrombus or stenosis in patients with STEMI. The device is FDA- and EMA-approved and routinely used in clinical practice. Quantitative and qualitative IVUS parameters will be collected and recorded for all participants to be correlated with clinical, imaging and angiographic outcomes of interest.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Target vessel failure at 12 months of follow-up in association with IVUS measurements | Follow-up will be obtained using online patient-reported outcome measurements by email or standardized telephone calls at 30 days, 6 months and 12 months after the procedure. Primary follow-up outcome of interest is the composite endpoint of target vessel failure (cardiac death, new-onset heart failure, target vessel myocardial infarction, clinically driven target vessel revascularization or target lesion revascularization). | 2 years | 
| All-cause mortality at 12 months of follow-up in association with IVUS measurements | Co-primary study outcome will be the investigation of all-cause mortality (i.e., death from any cause) after hospitalization and during follow-up. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital (post-PCI) adverse events in association with IVUS measurements | The composite endpoint of in-hospital (post-PCI) adverse events includes: cardiac tamponade, need for CABG, shock, in-hospital mortality, acute kidney failure, bleeding, stroke. | 2 years | 
| Pre-procedural angiographic outcomes in association with IVUS measurements | Pre-procedural Thrombolysis in myocardial infarction (TIMI) flow, thrombus burden classification, culprit vessel, number of diseased vessels, and the SYNergy between percutaneous intervention with TAXus DES and cardiac surgery (SYNTAX) score will be recorded and associated with pre-procedural IVUS measurements. Higher SYNTAX score and lower TIMI flow represent greater obstruction in the diseased vessels. | 2 years | 
| Post-procedural angiographic outcomes in association with IVUS measurements | Post-procedural TIMI flow, angiographically evident residual thrombus, no-reflow phenomenon, myocardial blush grade, and distal embolization will be recorded and associated with IVUS measurements. | 2 years | 
| Post-PCI iFR measurement in association with IVUS measurements | iFR=ratio of distal coronary pressure (Pd) to the aortic pressure (Pa) during an isolated period during diastole. | 2 years | 
| Microtomographic thrombus volume in association with IVUS measurements | Micro-CT derived volume of the extracted thrombotic material will be correlated with IVUS measurements. | 2 years | 
| Microtomographic thrombus porosity in association with IVUS measurements | Micro-CT derived porosity of the extracted thrombotic material will be correlated with IVUS measurements. | 2 years | 
| Microtomographic thrombus density in association with IVUS measurements | Micro-CT derived density of the extracted thrombotic material will be correlated with IVUS measurements. | 2 years | 
| Νumber and type of stents in association with IVUS measurements | Νumber and type of stents used will be recorded and associated with IVUS measurements. | 2 years | 
| Stent length and diameter in association with IVUS measurements | Stent length and diameter will be recorded and associated with IVUS measurements. | 2 years | 
| Contrast volume in association with IVUS measurements | Volume of the contrast used will be recorded and associated with IVUS measurements. | 2 years | 
| Radiation dose in association with IVUS measurements | Peri-procedural radiation dose will be recorded and associated with IVUS measurements. | 2 years | 
| Procedural duration in association with IVUS measurements | Procedural duration will be recorded and associated with IVUS measurements. | 2 years | 
| Post-PCI stent underexpansion, deformation or malapposition in association with baseline IVUS measurements | Stent underexpansion, deformation or malapposition (yes/no) will be recorded and associated with baseline IVUS measurements. | 2 years | 
| Post-PCI edge dissection in association with baseline IVUS measurements | Edge dissection (yes/no) will be recorded and associated with baseline IVUS measurements. | 2 years | 
| Post-PCI high plaque burden at stent edges, residual focal lesions or tissue protrusion through the stent struts in association with baseline IVUS measurements | High plaque burden at stent edges, residual focal lesions or tissue protrusion through the stent struts (yes/no) will be recorded and associated with baseline IVUS measurements. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVUS, Thrombus, STEMI