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

NCT ID: NCT02245048

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-05-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Stress Echocardiography (SE)

Subjects will undergo CIMT measurements.

Carotid Intima-Media Thickness (CIMT)

Intervention Type OTHER

Interventions

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Carotid Intima-Media Thickness (CIMT)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Esaote North America

UNKNOWN

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Tasneem Z. Naqvi, M.D.

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tasneem Naqvi, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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13-008535

Identifier Type: -

Identifier Source: org_study_id

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