Assessing Microvascular Resistance Via IMR To Predict Cumulative Outcome in STEMI Patients Undergoing Primary PCI

Study Overview
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Brief Summary
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The purpose of this study is to assess whether the Index of Microcirculatory Resistance (IMR) can be considered a prognostic predictor for the occurrence of events at one year of follow up after primary Percutaneous Coronary Intervention (PCI) in ST-Elevation Myocardial Infarction (STEMI) patients. Any correlation between IMR and the short and medium term outcomes, defined as cardiovascular death, re-Myocardial Infarct (MI), re-hospitalization for Heart Failure (HF), resuscitation or Implantable Cardioverter Defibrillator (ICD) appropriate shock, will be assessed in the study.

Detailed Description
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Prospective, multicentre study designed to evaluate IMR ability to predict events occurrence, defined as Cardiovascular death, re-MI, re-hospitalization for HF, resuscitation or ICD appropriate shock, during a 1 year follow-up period. All participants will have the culprit lesion treated following clinical practice and guidelines; Fractional Flow Reserve (FFR) and IMR will be measured after the primary PCI procedure to evaluate treatment success and myocardial viability. Non-culprit lesions will be functionally evaluated through FFR index and will be treated if FFR will show functional stenosis. FFR and IMR will be measured to evaluate treatment success and myocardial viability. Patients will be followed-up at 1m, 6m and 1y periods.

Official Title
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Assessing Microvascular Resistance Via IMR To Predict Cumulative Outcome in STEMI Patients Undergoing Primary PCI (AMICRO)

Conditions
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Multi Vessel Coronary Artery Disease, STEMI

Intervention / Treatment
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* Device: PressureWire Certus guidewire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient of legal age in hosting country able and willing to provide informed consent form Hospital admission either within 12 h of symptom onset or between 12 and 24 h after onset with evidence of continuing ischemia Electrocardiographic ST-segment elevation ≥1 mm in two or more contiguous ECG leads, or with a left bundle-branch block (LBBB) Multivessel diseased patients with lesions in the proximal 2/3 part of the vessels Culprit Lesion EyeBall (EB) identified during evaluation of basal angiography Presence of at least one non-culprit lesion >50% EB detected in the basal angiography and eligible for PCI for which the operators decision is to perform a staged pre-discharge angioplasty procedure Exclusion Criteria: Patients who cannot give informed consent A life expectancy of less than 1 year Patients who are pregnant or nursing Contra-indication to angiography Allergy/intolerance to Adenosine Contra-indication/Allergy/Intolerance to contrast media or to medical therapy foreseen for PCI Documented allergy to Adenosine diphosphate (ADP) inhibitors (aspirin and clopidogrel) New infarct on the same area of a previous infarct Critical non treatable Lesion EB>70% downstream of the culprit lesion Absence of non-culprit lesion/s Patient with hemodynamic instability not controllable with medical therapy and/or need intra aortic balloon pump implantation (IABP) Prior Coronary Artery Bypass Graft (CABG) or indication for CABG Patients with Left Main (LM) coronary artery disease requiring revascularization

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: IMR evaluation<br>Assessment of IMR index in coronaries through PressureWire Certus guidewire | Device: PressureWire Certus guidewire<br>* Assessment of IMR index in coronaries through PressureWire Certus guidewire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of: cardiovascular death*, re-myocardial infarct, re-hospitalization for heart failure (HF) and Congestive Heart Failure (CHF), resuscitation or ICD appropriate shock. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New CHF during index hospitalization |  | At the end of hospital stay, an expected average of 5-10 days | 
| Left Ventricular (LV) remodeling |  | 1 year | 
| Need for new revascularization (revascularization yes/no) |  | 1 year | 
| Stent thrombosis (thrombosis yes/no) |  | 1 year | 
| ST resolution or residual ST elevation post PCI (Electrocardiographic ST-segment elevation in two or more contiguous electrocardiogram (ECG) leads) |  | At the end of hospital stay, an expected average of 5-10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, IMR, FFR, microcirculatory