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

Last updated: June 29, 2016
Sponsor: Federal University of São Paulo
Overall Status: Completed

Phase

N/A

Condition

Chest Pain

Coronary Artery Disease

Cardiac Disease

Treatment

N/A

Clinical Study ID

NCT01437553
BSCI-01
  • Ages 18-75
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Hemodynamic instability

  • Clinical signs of post-AMI ventricular dysfunction (Killip III/IV)

  • Angiographic findings of (1)coronary anatomy with significant tortuosity, (2) criticalcoronary obstruction preventing the passage of the IVUS catheter and (3) totalocclusion of any of the three epicardial coronary arteries.

Study Design

Total Participants: 100
Study Start date:
August 01, 2011
Estimated Completion Date:
March 31, 2013

Study Description

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.

Connect with a study center

  • Universidade Federal de São Paulo

    São Paulo,
    Brazil

    Site Not Available

  • Universidade Federal de São Paulo

    São Paulo,
    Brazil

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.