NCT02224339

Brief 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:

  • 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.
  • 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

August 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

4.1 years

First QC Date

August 21, 2014

Last Update Submit

March 4, 2019

Conditions

AtherosclerosisCarotid Artery Plaque

Keywords

Atherosclerosiscarotid plaqueContrast-enhanced ultrasoundMajor Adverse Cardiovascular Events

Outcome Measures

Primary Outcomes (1)

  • cumulative incidence of cardiac death during the 24 months followup

    The primary endpoint is the cumulative incidence of cardiac death during the 24 months followup from the SE and carotid imaging (strain and CEUS).

    6, 12 and 24 months

Secondary Outcomes (1)

  • Evaluate the prognostic role of carotid CEUS and two-dimensional speckle tracking strain imaging for prediction of MACE

    6,12,24 months

Study Arms (1)

plaque neovascular and stress echo

After the SE and CEUS examination, patients will be grouped per the result of SE and CEUS as follows: group I: plaque neovascularization and normal wall motion; group II: plaque neovascularization and abnormal wall motion; group III: no plaque neovascularization and abnormal wall motion; group IV: no plaque neovascularization and normal wall motion.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Suspected or known to have CAD and referred to stress echo lab.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Related Links

MeSH Terms

Conditions

AtherosclerosisCarotid Stenosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesCarotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Patricia A Pellikka, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2014

First Posted

August 25, 2014

Study Start

September 1, 2014

Primary Completion

October 1, 2018

Study Completion

January 1, 2019

Last Updated

March 6, 2019

Record last verified: 2019-03

Locations

US(1)