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

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
iMAP
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Coronary Syndrome focused on measuring IVUS, iMAP, Catheterization, Acute Coronary Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Federal de São Paulo

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

IVUS

Arm Description

Patients undergoing catheterization due to acute coronary syndrome will have IVUS done with grayscale and iMAP analysis performed.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 18, 2011
Last Updated
June 29, 2016
Sponsor
Federal University of São Paulo
Collaborators
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01437553
Brief Title
Imaging Whole Coronary Artery With Intravascular Ultrasound (Ivus) And Imap For Plaque Tissue Composition In Patients With Acute Myocardial Infarction
Acronym
iWONDER
Official Title
Registry Using IVUS and iMAP to Evaluate Atherosclerotic Coronary Plaque in Acute Coronary Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
IVUS, iMAP, Catheterization, Acute Coronary Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IVUS
Arm Type
Other
Arm Description
Patients undergoing catheterization due to acute coronary syndrome will have IVUS done with grayscale and iMAP analysis performed.
Intervention Type
Device
Intervention Name(s)
iMAP
Intervention Description
IVUS and iMAP analysis for acute coronary syndromes
Primary Outcome Measure Information:
Title
Atherosclerotic plaque composition
Description
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.
Time Frame
Patients will be followed during in-hospital period, an expect average of 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriano M Caixeta, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cristiano F Souza, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio C Carvalho, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Claudia M Alves, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Federal de São Paulo
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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