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Clinical Trials/NCT02245048
NCT02245048
Completed
Not Applicable

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

Mayo Clinic1 site in 1 country73 target enrollmentOctober 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Risk Stratification
Sponsor
Mayo Clinic
Enrollment
73
Locations
1
Primary Endpoint
% Patients w/ Abnormal IMT vs. % Patients w/ Positive Ischemia on Stress Echocardiogram
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
May 2016
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tasneem Z. Naqvi, M.D.

PI

Mayo Clinic

Eligibility Criteria

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

Outcomes

Primary Outcomes

% 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.

Study Sites (1)

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