Imaging Whole Coronary Artery With Intravascular Ultrasound (Ivus) And Imap For Plaque Tissue Composition In Patients With Acute Myocardial Infarction (iWONDER)
|ClinicalTrials.gov Identifier: NCT01437553|
Recruitment Status : Completed
First Posted : September 21, 2011
Last Update Posted : July 1, 2016
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).
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome||Device: iMAP||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Registry Using IVUS and iMAP to Evaluate Atherosclerotic Coronary Plaque in Acute Coronary Syndromes|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2013|
Patients undergoing catheterization due to acute coronary syndrome will have IVUS done with grayscale and iMAP analysis performed.
IVUS and iMAP analysis for acute coronary syndromes
- Atherosclerotic plaque composition [ Time Frame: Patients will be followed during in-hospital period, an expect average of 7 days ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437553
|Universidade Federal de São Paulo|
|São Paulo, Brazil|
|Principal Investigator:||Adriano M Caixeta, PhD||Federal University of São Paulo|
|Principal Investigator:||Cristiano F Souza, MD||Federal University of São Paulo|
|Study Director:||Antonio C Carvalho, PhD||Federal University of São Paulo|
|Study Director:||Claudia M Alves, PhD||Federal University of São Paulo|