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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Cristiano Freitas de Souza, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01437553
First received: September 18, 2011
Last updated: September 21, 2011
Last verified: September 2011
  Purpose

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 Intervention
Acute Coronary Syndrome
Device: iMAP

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Registry Using IVUS and iMAP to Evaluate Atherosclerotic Coronary Plaque in Acute Coronary Syndromes

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Atherosclerotic plaque composition [ Time Frame: Patients will be followed during in-hospital period, an expect average of 7 days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: August 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
IVUS
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
Other Name: iMAP

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437553

Contacts
Contact: Claudia M Alves, PhD 55-11-5576-4014 cmralves@uol.com.br
Contact: Cristiano F Souza, MD 55-11-5576-4016 crissouza80@hotmail.com

Locations
Brazil
Universidade Federal de São Paulo Recruiting
São Paulo, Brazil
Contact: Claudia M Alves, PhD    55-11-55764014    cmralves@uol.com.br   
Contact: Cristiano F Souza, MD    55-11-5576-4016    crissouza80@hotmail.com   
Principal Investigator: Cristiano F Souza, MD         
Principal Investigator: Adriano M Caixeta, MD, PhD         
Sponsors and Collaborators
Federal University of São Paulo
Boston Scientific Corporation
Investigators
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
  More Information

No publications provided

Responsible Party: Cristiano Freitas de Souza, M.D., Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01437553     History of Changes
Other Study ID Numbers: BSCI-01
Study First Received: September 18, 2011
Last Updated: September 21, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Federal University of São Paulo:
IVUS
iMAP
Catheterization
Acute Coronary Syndrome

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014