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Completed

NCT Number: NCT02245048

CIMT 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.

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Key information

Conditions

Cardiovascular Risk Stratification Carotid Intima-media Thickness (CIMT) Stress Echocardiography (SE)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Scottsdale, Arizona, 85254, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carotid Intima-Media Thickness (CIMT)

Other

Primary outcomes

  1. % 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Esaote North America

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 19, 2014
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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