NCT01437553

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

July 1, 2016

Status Verified

June 1, 2016

Enrollment Period

7 months

First QC Date

September 18, 2011

Last Update Submit

June 29, 2016

Conditions

Acute Coronary Syndrome

Keywords

IVUSiMAPCatheterizationAcute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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.

    Patients will be followed during in-hospital period, an expect average of 7 days

Study Arms (1)

IVUS

OTHER

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

Device: iMAP

Interventions

iMAPDEVICE

IVUS and iMAP analysis for acute coronary syndromes

IVUS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \< 75 years
  • Diagnosis of NSTEMI/STEMI with prior use of fibrinolytics in the past 7 days
  • Signature of the Term of Informed Consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de São Paulo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Adriano M Caixeta, PhD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

  • Cristiano F Souza, MD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

  • Antonio C Carvalho, PhD

    Federal University of São Paulo

    STUDY DIRECTOR

  • Claudia M Alves, PhD

    Federal University of São Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

September 18, 2011

First Posted

September 21, 2011

Study Start

August 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2013

Last Updated

July 1, 2016

Record last verified: 2016-06

Locations

BR(1)