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

NCT ID: NCT05480332

Last Updated: 2022-07-29

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-01
• Study Completion Date: 2022-07-01

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.

Detailed Description

Atherosclerosis is a disease affecting the function of arteries, and is one of the underlying causes of stroke, heart attack and other cardiovascular diseases. These diseases are some of the highest causes of morbidity and mortality in North America. As an inflammatory disease that involves the endothelium of blood vessels, atherosclerosis causes arteries to stiffen and become blocked with plaques. This leads to decreased function of these arteries, which at first is asymptomatic, but at later stages can block blood supply to the heart or brain.

The Endo-PAT 2000 is a device designed to measure endothelial function using finger probes placed onto the finger tip of a patient. It is made to detect the presence of peripheral endothelial dysfunction, which develops under the same mechanisms as coronary disease. Risk factors for heart disease are well recognized, and include gender, race, weight, smoking status, and the presence of hypertension, diabetes, and elevated cholesterol. While these factors are monitored in the clinical setting, the actual damage to vascular endothelium has previously been difficult to quantify. The EndoPAT system offers a novel method of assessing endothelial function as an aggregate outcome of all of these risk factors.

Conditions

Atherosclerosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

EndoPAT Measured

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

EndoPAT

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All patients 18 years of age and older are eligible

Exclusion Criteria

• None except age < 18 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Karthikeyan Ananthasubramaniam

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

EndoPAT

Identifier Type: -

Identifier Source: org_study_id