AtherosclerosisNCT05480332
Defining the Role of Endothelial Function Assessment Using EndoPAT in Cardiovascular Risk Screening : Comparison to Traditional Risk Assessment Tools and CIMT Testing
An observational study of Atherosclerosis, run by Henry Ford Health System.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- EndoPAT
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients >/= 18 years consenting for participation are eligible. There are no speicifc exclusion critieria except age < 18 years.
Who may be able to join
- All patients 18 years of age and older are eligible
Who cannot join
- None except age < 18 years
About this study
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.
Read the 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
- Being tested
- EndoPAT
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoPATDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| EndoPAT Measured | Study participants who will undergo EndoPAT testing to obtain a non-invasive measurement of their endothelial function Receives: Device: EndoPAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Function as Indicated by the Reactive Hyperemia Index Score
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 May 2015 (estimated)
- Primary completionMay 2016 (estimated)
- Study completion1 Jul 2022
Why it stopped: Unable to execute internal logistics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karthikeyan Ananthasubramaniam, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480332
- Sponsor's protocol ID
- EndoPAT
- Status last verified
- Jul 2022
- First submitted
- 28 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Role of Endothelial Function Assessment Using EndoPAT in Cardiovascular Risk Screening : Comparison to Traditional Risk Assessment Tools and CIMT Testing
- ClinicalTrials.gov ID
- NCT05480332
- Acronym / sponsor ID
- EndoPAT
- Conditions
- Atherosclerosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to execute internal logistics
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 1 May 2015 (estimated)
- Primary completion
- May 2016 (estimated)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndoPAT Measured | – | Device: EndoPATStudy participants who will undergo EndoPAT testing to obtain a non-invasive measurement of their endothelial function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients >/= 18 years consenting for participation are eligible. There are no speicifc exclusion critieria except age < 18 years.
Key inclusion criteria (1 listed)
- All patients 18 years of age and older are eligible
Key exclusion criteria (1 listed)
- None except age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoPATWe 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. | Device | EndoPAT Measured |
Primary outcome
Endothelial Function as Indicated by the Reactive Hyperemia Index Score
Time frame: Immediate
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by Henry Ford Health System.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial Function as Indicated by the Reactive Hyperemia Index Score (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.