New Technologies to Determine Carotid Plaque Vulnerability

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 14-000555
    NCT ID: NCT02224339
    Sponsor Protocol Number: 14-000555

About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Study eligibility criteria: age ≥ 18 years, suspected or known to have CAD and referred to stress echo lab.

Exclusion Criteria:

  • Previous carotid surgery or angioplasty; Stroke, cardiogenic shock, pulmonary hypertension, heart failure; other serious disease; Prior contraindication to contrast agent.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Patricia Pellikka, M.D.

Closed for enrollment

Contact information:

Cynthia Cassidy

(507)266-1621

McCoyCassidy.Cynthia@mayo.edu

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CLS-20142709

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