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

NCT05480332 | Withdrawn

• 1 other identifier: EndoPAT
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Endothelial Function as Indicated by the Reactive Hyperemia Index Score

  Immediate

Study Arms (1)

EndoPAT Measured

Study participants who will undergo EndoPAT testing to obtain a non-invasive measurement of their endothelial function

Device: EndoPAT

Interventions

EndoPAT DEVICE

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.

EndoPAT Measured

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients \>/= 18 years consenting for participation are eligible. There are no speicifc exclusion critieria except age \< 18 years.

You may qualify if:

• All patients 18 years of age and older are eligible

You may not qualify if:

• None except age \< 18 years

Sponsors & Collaborators

• Henry Ford Health System: lead

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: July 29, 2022
• Study Start: May 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: July 1, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07