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Defining the Role of Endothelial Function Assessment Using EndoPAT in Cardiovascular Risk Screening : Comparison to Traditional Risk Assessment Tools and CIMT Testing

NCT05480332 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2022-07-29

No results posted yet for this study

Summary

Our study aims to evaluate endothelial function using the non-invasive EndoPAT device, and compare this assessment to traditional cardiovascular risk calculation tools and carotid intima media thickness measurements. We look to determine whether the discovery of endothelial dysfunction provides incremental risk stratification over traditional and CIMT methods of cardiovascular risk assessment.

Conditions

Interventions

DEVICE

EndoPAT

We will use the standard non-invasive EndoPAT finger probes to conduct the studies. A single finger on each hand will be placed into a probe equipped with pressure sensors. A baseline recording period will be obtained. After five minutes, an occlusion phase will start where a blood pressure cuff on the patient's non-dominant arm will be inflated to 60mmHg above the patient's systolic pressure, or 200mmHg, whichever is higher. This phase will be conducted in concert with the standard instructions provided with the EndoPAT system. The occlusion phase will last for five minutes, after which time the cuff will be deflated. There will then be a five minute post-occlusion recording period. The test will then be completed. The baseline period, occlusion period, and post-occlusion period will then be analyzed. A reactive hyperemia index score will be the desired output from the EndoPAT computer software, and will become the primary data point.

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-01
Primary Completion
2016-05-31
Completion
2022-07-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05480332 on ClinicalTrials.gov