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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01437553
Recruitment Status : Completed
First Posted : September 21, 2011
Last Update Posted : July 1, 2016
Boston Scientific Corporation
Information provided by (Responsible Party):
Cristiano Freitas de Souza, Federal University of São Paulo

Brief 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).

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Device: iMAP Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
Patients undergoing catheterization due to acute coronary syndrome will have IVUS done with grayscale and iMAP analysis performed.
Device: iMAP
IVUS and iMAP analysis for acute coronary syndromes

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01437553

Universidade Federal de São Paulo
São Paulo, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Boston Scientific Corporation
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

Responsible Party: Cristiano Freitas de Souza, M.D., Federal University of São Paulo Identifier: NCT01437553     History of Changes
Other Study ID Numbers: BSCI-01
First Posted: September 21, 2011    Key Record Dates
Last Update Posted: July 1, 2016
Last Verified: June 2016

Keywords provided by Cristiano Freitas de Souza, Federal University of São Paulo:
Acute Coronary Syndrome

Additional relevant MeSH terms:
Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action