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New Technologies to Determine Carotid Plaque Vulnerability

NCT02224339 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 216

Last updated 2019-03-06

No results posted yet for this study

Summary

Hypothesis: Identification of vulnerable atherosclerotic plaques (with or without neovascularization) using carotid CEUS is an independent predictor of MACE (over clinical risk factors, stress echo wall motion results, and carotid ultrasound two-dimensional speckle tracking strain indices).

Primary Aims:

1. Evaluate the diagnostic role of carotid CEUS and two-dimensional speckle tracking strain imaging for detection of carotid plaque:

* To determine the feasibility and safety of Carotid CEUS and Two-dimensional speckle tracking strain imaging SE .
* To determine if carotid CEUS and two-dimensional speckle tracking strain imaging findings are associated with coronary angiographic results in those patients undergoing clinically indicated cardiac catheterization.
* To determine the diagnostic accuracy of CEUS in identifying a vulnerable atherosclerotic plaque and neovascularization compared to carotid MRI, in a subset of patients.
2. Evaluate the prognostic role of carotid CEUS and two-dimensional speckle tracking strain imaging for prediction of MACE:

* To determine if plaque identification (with or without neovascularization) on Carotid CEUS SE can improve the overall prediction of MACE over stress echo results alone
* To determine if Carotid ultrasound two-dimensional speckle tracking strain indices can improve the overall prediction of MACE over stress echo results alone.
* To determine if the detection of plaque neovascularization by Carotid CEUS is an independent predictor of MACE (over clinical risk factors, stress echo wall motion results, and carotid ultrasound two-dimensional speckle tracking strain indices).

Conditions

Sponsors & Collaborators

  • GE Healthcare

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Patricia A Pellikka, M.D. · Mayo Clinic

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2018-10-31
Completion
2019-01-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02224339 on ClinicalTrials.gov