CIMT and Plaque Assessment Findings in Subjects Undergoing Stress Echocardiography For Risk Stratification

May 1, 2023 updated by: Tasneem Z. Naqvi, M.D., Mayo Clinic

Carotid Intima-Media Thickness and Plaque Assessment Findings in Subjects Undergoing Stress Echocardiography For Risk Stratification

The purpose of this research study is to determine if carotid artery ultrasound scanning can provide additional information for determining cardiovascular risk in patients.

Patients who agree to participate wil undergo non-invasive carotid intima-media thickness (CIMT) measurement and plaque assessment. Findings of CIMT will be compared to results of patient standard of care stress echocardiogram (SE) and of diastolic function.

We hypothesize tht 1) in patients undergoing SE for inappropriate or uncertain indications, CIMT and plaque assessment will provide useful risk stratification beyond use of traditional risk factors; 2) CIMT findings will correlate with results of SE in terms of exercise capacity and 3) Exercise capacity will correlate with diastolic function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

73

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

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85254
        • Mayo Clinic

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

Sampling Method

Non-Probability Sample

Study Population

Eligible patients will be undergoing standard of care stress echocardiography

Description

Inclusion Criteria:

  • Asymptomatic
  • No prior cardiac history (MI, PTCA, CABG, angina)
  • No peripheral vascular disease
  • No history of stroke or TIA
  • Statins, antihypertensives, ASA treatment OK

Exclusion Criteria:

  • History of CAD, CABG, PTCA, coronary or peripheral stenting
  • History of stroke/TIA/peripheral vascular disease
  • Inability to exercise on the treadmill
  • Unwilling/unable to sign informed consent
  • History of neck radiation or neck surgery or inability to obtain neck images
  • End stage renal disease
  • Preoperative evaluation
  • History of chest pain

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
Intervention / Treatment
Stress Echocardiography (SE)
Subjects will undergo CIMT measurements.
Other: Carotid Intima-Media Thickness (CIMT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% Patients w/ Abnormal IMT vs. % Patients w/ Positive Ischemia on Stress Echocardiogram
Time Frame: Baseline
We are comparing the % of patients with abnormal IMT defined as presence of plaque (= or >1.5mm) or CIMT >75% percentile for age, race, and gender compared to % of patients with positive ischemia on stress echocardiogram as defined by a new wall motion abnormality on echocardiogram with stress.
Baseline

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Collaborators

Esaote North America

Investigators

  • Principal Investigator: Tasneem Naqvi, MD, Mayo Clinic

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.

Helpful Links

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)

October 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

September 17, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13-008535

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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