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

Completed

• Conditions: Cardiovascular Risk Stratification; Carotid Intima-media Thickness (CIMT); Stress Echocardiography (SE)
• Interventions: Other: Carotid Intima-Media Thickness (CIMT)

• Registration Number: NCT02245048
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-18
• Study First Posted: 2014-09-19
• Study Start: 2014-10
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-01
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stress Echocardiography (SE)	Carotid Intima-Media Thickness (CIMT)	Subjects will undergo CIMT measurements.

Primary Outcome Measures

Name	Time	Method
% Patients w/ Abnormal IMT vs. % Patients w/ Positive Ischemia on Stress Echocardiogram	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States