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
1 other identifier
observational
73
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2014
CompletedFirst Posted
Study publicly available on registry
September 19, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedMay 3, 2023
May 1, 2023
1.6 years
September 17, 2014
May 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
% Patients w/ Abnormal IMT vs. % Patients w/ Positive Ischemia on Stress Echocardiogram
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
Study Arms (1)
Stress Echocardiography (SE)
Subjects will undergo CIMT measurements.
Interventions
Eligibility Criteria
Eligible patients will be undergoing standard of care stress echocardiography
You may qualify if:
- Asymptomatic
- No prior cardiac history (MI, PTCA, CABG, angina)
- No peripheral vascular disease
- No history of stroke or TIA
- Statins, antihypertensives, ASA treatment OK
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Esaote North Americacollaborator
Study Sites (1)
Mayo Clinic
Scottsdale, Arizona, 85254, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tasneem Naqvi, MD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
September 17, 2014
First Posted
September 19, 2014
Study Start
October 1, 2014
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
May 3, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share