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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02245048
Enrollment
73
Registered
2014-09-19
Start date
2014-10-31
Completion date
2016-05-31
Last updated
2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Cardiovascular Risk Stratification, Carotid intima-media thickness (CIMT), Stress echocardiography (SE)

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.

Interventions

OTHERCarotid Intima-Media Thickness (CIMT)

Sponsors

Esaote North America
CollaboratorUNKNOWN
Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
% Patients w/ Abnormal IMT vs. % Patients w/ Positive Ischemia on Stress EchocardiogramBaselineWe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026