Incident COronary EveNts Identified by Computed Tomography (ICONIC)

November 18, 2019 updated by: Weill Medical College of Cornell University
The Incident COronary EveNts Identified by Coronary Tomography (ICONIC) trial is a nested, case-control study derived from the dynamic CONFIRM registry, and is based on propensity scoring methods to match subjects with (cases) or without (controls) acute coronary syndrome (ACS). Our primary objective is to determine CCTA-based atherosclerotic plaque characteristics that would help elucidate precursors of incident ACS, with the secondary objective being an analysis of gender-specific disparities.

Study Overview

Status

Completed

Conditions

Detailed Description

Acute myocardial infarctions resulting from unstable plaque in patients with coronary artery disease (CAD) account for a significant portion of cardiovascular morbidity and mortality. Although prediction models that incorporate traditional risk factors have been developed in order to risk stratify patients at highest risk for development of subsequent cardiovascular events, such models lack precision and are often found to over or under-estimate risk. Moreover, current clinical practice has focused on stenosis severity as a predictor of future plaque erosion and/or rupture, in spite of the fact that evidence from intravascular ultrasound (IVUS) studies, such as the PROSPECT trial, demonstrate that ACS events are more likely to occur in less than severely stenotic lesions. Furthermore, there is incomplete understanding of the influence of gender on atherosclerotic plaque composition and downstream coronary events, given the chronologic and prognostic differences between men and women in atherosclerotic cardiovascular disease.

Several studies have attempted elucidating characteristics of vulnerable plaque using invasive imaging modalities such as IVUS. However, such studies have several limitations, most significantly is the fact that plaque characterization was performed after an acute coronary event, which limits the ability to isolate baseline plaque characteristics from changes following the acute event. Noninvasive evaluation of atherosclerotic coronary disease using coronary computed tomographic angiography (CCTA) has been established as an accurate and readily available imaging modality in clinical practice. In addition to the evaluation of diameter stenosis, CCTA is capable of evaluation plaque composition as well as arterial remodeling, in a similar fashion to IVUS. The agreement between plaque characterization using IVUS and CCTA has been demonstrated in several large-scale trials. Nevertheless, there are several key aspects that have yet to be addressed, including the utility of plaque characterization by CCTA for determination of future cardiovascular events, and gender-based differences in atherosclerotic plaque composition in patients with stable and unstable coronary artery disease.

The ICONIC trial was designed as a nested case-control study based on the previously published CONFIRM registry, evaluating demographic, clinical as well as baseline CCTA-determined plaque composition in 238 patients with subsequent ACS events and 238 matched patients without ACS events. As previously described, ICONIC utilizes CCTA to comprehensively assess plaque morphology and characteristics, in addition to arterial wall changes in order to determine characteristics implicated in future adverse events, beyond what has been traditionally described using invasive imaging modalities. The primary goal is to investigate differences in atherosclerotic plaque composition in patients with ACS, compared to patients with stable coronary disease. The secondary goal is to determine gender-specific differences in plaque composition in both stable and unstable coronary artery disease.

Study Type

Observational

Enrollment (Actual)

476

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
        • Innsbruck Medical University
  • Canada
      • Vancouver, Canada
        • Providence Health Care St. Paul's Hospital
    • Ontario
      • Ottawa, Ontario, Canada
        • University of Ottawa Heart Institute
  • Germany
      • Munich, Germany
        • University of Munich
  • Italy
      • Milan, Italy
        • Department of Clinical Sciences and Community Health, University of Milan & Centro Cardiologico Monzino, IRCCS
      • Parma, Italy
        • University Hospital Of Parma
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Severance Cardiovascular Hospital
  • Netherlands
      • Leiden, Netherlands
        • Leiden University Medical Center
  • Portugal
      • Lisboa, Portugal
        • Hospital da Luz
  • United States
    • Florida
      • Miami, Florida, United States, 33176
        • Baptist Hospital of Miami
    • Maryland
      • Bethesda, Maryland, United States, 20889
        • Walter Reed Army Medical Center
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects were recruited from 13 international sites in Asia, Europe and North America, with central adjudication of clinical outcomes and core-laboratory measurement of CCTA-based plaque characteristics.

Subjects recruited in ICONIC represent individuals suspected of having CAD, meeting the inclusion criteria, and undergoing coronary luminal evaluation using ≥ 64-detector row CCTA. Subjects with established CAD were excluded from the trial. The two arms of the study were patients with baseline CCTA and subsequent occurrence of an ACS event (cases) and patients with baseline CCTA and no subsequent ACS event (controls).

Description

Cases:

Inclusion criteria:

  • Age ≥18 years.
  • Adjudicated STEMI / NSTEMI / UA / Unclassified MI (except for type 4a, 4b, or 5 MI)
  • Baseline CCTA.

Exclusion criteria:

  • Myocardial infarction not meeting the definition of ACS with missing cardiac biomarkers.
  • Prior history of CAD (revascularization or MI).
  • Prior revascularization (PCI or CABG).
  • ACS in a previously revascularized segment.
  • Type 4a, 4b, or 5 MI.

Controls

Inclusion criteria:

  • Age ≥18 years.
  • Propensity score matched.

Exclusion criteria:

  • Prior history of CAD (revascularization or MI).
  • Death as an outcome.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cases
Patients with acute coronary syndrome (ACS).
Controls
Patients without acute coronary syndrome (ACS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ACS
Time Frame: within 5 years
ACS: ST elevation MI (STEMI), non-ST elevation MI (NSTEMI), or unstable angina (UA)
within 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
STEMI and NSTEMI
Time Frame: within 5 years
ST elevation MI (STEMI) or Non-ST elevation MI (NSTEMI)
within 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2012

Primary Completion (Actual)

April 30, 2017

Study Completion (Actual)

April 30, 2017

Study Registration Dates

First Submitted

November 4, 2016

First Submitted That Met QC Criteria

November 4, 2016

First Posted (Estimate)

November 8, 2016

Study Record Updates

Last Update Posted (Actual)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1310014469

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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