Imaging Whole Coronary Artery With Intravascular Ultrasound (Ivus) And Imap For Plaque Tissue Composition In Patients With Acute Myocardial Infarction (iWONDER)
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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 |
- 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 |
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| 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 |
| 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 | |
| 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:
|
Myocardial Infarction Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Angina Pectoris Chest Pain Pain Signs and Symptoms Fluspirilene Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013