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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02245048
Recruitment Status : Completed
First Posted : September 19, 2014
Last Update Posted : June 10, 2019
Sponsor:
Collaborator:
Esaote North America
Information provided by (Responsible Party):
Tasneem Z. Naqvi, M.D., 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.


Condition or disease Intervention/treatment
Cardiovascular Risk Stratification Carotid Intima-media Thickness (CIMT) Stress Echocardiography (SE) Other: Carotid Intima-Media Thickness (CIMT)

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Study Type : Observational
Actual Enrollment : 73 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Carotid Intima-Media Thickness and Plaque Assessment Findings in Subjects Undergoing Stress Echocardiography For Risk Stratification
Actual Study Start Date : October 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Group/Cohort Intervention/treatment
Stress Echocardiography (SE)
Subjects will undergo CIMT measurements.
Other: Carotid Intima-Media Thickness (CIMT)



Primary Outcome Measures :
  1. % 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible patients will be undergoing standard of care stress echocardiography
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02245048


Locations
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United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85254
Sponsors and Collaborators
Mayo Clinic
Esaote North America
Investigators
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Principal Investigator: Tasneem Naqvi, MD Mayo Clinic
Additional Information:
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Responsible Party: Tasneem Z. Naqvi, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02245048    
Other Study ID Numbers: 13-008535
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tasneem Z. Naqvi, M.D., Mayo Clinic:
Cardiovascular Risk Stratification
Carotid intima-media thickness (CIMT)
Stress echocardiography (SE)