Imaging Whole Coronary Artery With Intravascular Ultrasound (Ivus) And Imap For Plaque Tissue Composition In Patients With Acute Myocardial Infarction

Study Overview
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Brief Summary
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The iWONDER trial has the following objective: To analyze the morphological, phenotypic and tissue characteristics of atherosclerotic plaques angiographically considered culprit and not-culprit in patients undergoing coronary angiography due to STEMI (ST-elevation myocardial infarction).

Detailed Description
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Coronary artery angiography (CA) is a two-dimensional silhouette of the arterial lumen from a complex three dimensional vascular structure. This exam has several limitations already well documented, including shortening of the vessel, overlapping images, intra and inter-observer variability during the consideration of the severity of injuries. Besides, it offers great limitations in the diagnosis of the composition of atherosclerotic plaque. Furthermore, intravascular ultrasound (IVUS) provides a sensitive and reproducible measure of the dimensions of the vessel and allows direct visualization of the vessel wall, atherosclerotic plaque and arterial lumen. The utility of grayscale IVUS as prognostic tool and as a guide in percutaneous coronary interventions (PCI) is well established. More recently, IVUS has also provided new insights for safety and efficacy of drug eluting stent (DES). Advances in technology now allow IVUS to characterize the morphology and composition of plaques. Specifically, the analysis of the IVUS wave frequency - beyond the interpretation of wave lengths used in grayscale IVUS- enables in vivo analysis of atherosclerotic plaque composition with high sensitivity and specificity. Although previous studies have reported data using IVUS radiofrequency analysis, the use of a new modality (iMapTM, Boston Scientific, Santa Clara, CA, USA) for characterization of atherosclerotic plaque is poorly known.

Official Title
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Registry Using IVUS and iMAP to Evaluate Atherosclerotic Coronary Plaque in Acute Coronary Syndromes

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Device: iMAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age < 75 years Diagnosis of NSTEMI/STEMI with prior use of fibrinolytics in the past 7 days Signature of the Term of Informed Consent Exclusion Criteria: Hemodynamic instability Clinical signs of post-AMI ventricular dysfunction (Killip III/IV) Angiographic findings of (1)coronary anatomy with significant tortuosity, (2) critical coronary obstruction preventing the passage of the IVUS catheter and (3) total occlusion of any of the three epicardial coronary arteries.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: IVUS<br>Patients undergoing catheterization due to acute coronary syndrome will have IVUS done with grayscale and iMAP analysis performed. | Device: iMAP<br>* IVUS and iMAP analysis for acute coronary syndromes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atherosclerotic plaque composition | Atherosclerotic plaque composition of culprit and non-culprit lesions will be evaluated using grayscale IVUS and iMAP analysis in patients presenting with acute coronary syndrome. | Patients will be followed during in-hospital period, an expect average of 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVUS, iMAP, Catheterization, Acute Coronary Syndrome