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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02245048
• Collaborator: Esaote North America (Other)
• Enrollment: 73
• Location: 1
• Actual Duration (Months): 19
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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

Study Design

• 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: Oct 1, 2014
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. % 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Scottsdale	Arizona	United States	85254

Sponsors and Collaborators

• Mayo Clinic
• Esaote North America

Investigators

• Principal Investigator: Tasneem Naqvi, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Tasneem Z. Naqvi, M.D., PI, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02245048
• Other Study ID Numbers: 13-008535
• First Posted: Sep 19, 2014
• Last Update Posted: Jun 10, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Tasneem Z. Naqvi, M.D., PI, Mayo Clinic: Cardiovascular Risk Stratification; Carotid intima-media thickness (CIMT); Stress echocardiography (SE)

Study Results

No Results Posted as of Jun 10, 2019