Arterial DiseaseENDYNCT04651894
Relationship Between Digital Vascular Function Measured by EndoPAT® in elderlY Patients and Arterial Stiffness
An observational study of Arterial Disease and Frail Elderly Syndrome, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Due to the aging of populations worldwide, we observe an increase of age-related diseases and loss of autonomy with consequent personal, social, medical and economic implications. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arterial Disease, Frail Elderly Syndrome, Stiffness, Vascular
- What is being tested?
- reactive hyperaemia index measurement
- Type of treatment
- Medical device
- How many people
- 148 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2018to 3 Nov 2020
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 105 among these 148 patients were finally selected as they present ENDOPAT good signal
Who may be able to join
- age over 60 years
- referred to a day hospital check up
- arterial stiffness evaluation
- peripheral Arterial Tonometry Evaluation
Who cannot join
- atrial fibrillation during examination
- poor quality of the signals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross Sectional Relation of Digital Vascular Function Measured by EndoPAT® in elderlY Patients to Arterial Stiffness
Due to the aging of populations worldwide, we observe an increase of age-related diseases and loss of autonomy with consequent personal, social, medical and economic implications. The aging population is a target for geriatric medicine, necessitating the development of specific diagnostic and therapeutic approaches in order to estimate cardio vascular risk in these individuals.
It is thought that arterial stiffening and endothelial dysfunction are among the earliest vascular properties altered with the onset of cardiovascular disease. Moreover aging is characterized by progressive fragmentation and break down of the elastic components of the aortic media, which are partially replaced by highly cross-linked collagen leading to stiffening, dilation, and elongation of the aorta . A major underlying mechanism of these modifications is endothelial dysfunction due to high oxidative stress and low-grade inflammation. Reactive hyperemia index (RHI), a key outcome of peripheral arterial tonometry (PAT) has recently become a reliable tool to measure microvascular endothelial function. Some studies have recently demonstrated the interest to measure in elderly patients arterial stiffness parameters in order to prevent loss of autonomy. This cross sectional study aimed at demonstrating the link between arterial stiffness evaluated by pulse wave velocity and endothelial dysfunction evaluated by RHI to implement the tools of cardio vascular risk evaluation in a population of elderly patients referred in a geriatric day hospital.
Read the detailed description
This study is a cross sectional monocentric retrospective study in a geriatric day hospital population coming for frailty and cardio vascular evaluation : clinical data of 148 patients hospitalized from April 2018 to December 2019 (20 months) of the Measurement of the ARterial-Cardiac AGEing and prevention evaluation of FRailty (MARCAGE.FR) geriatric day hospital of Nancy were retrospectively analyzed. Eligible patients were those who had benefited from an EndoPAT® measurement and arterial stiffness evaluation and aged over 60 years. Exclusion criteria to analyze aortic pulse wave velocity was the presence of atrial fibrillation and for EndoPAT® a poor quality of the signal. 105 among these 148 patients were finally selected as they present EndoPAT® good signal (reviewed by two operators).
All subjects arrived in a fasting state at the geriatric day hospital where anthropometric, frailty evaluation, hemodynamic and transcutaneous measurements of aortic pulse wave velocity (AoPWV) were performed at rest. Some of them had a cerebral Magnetic resonance imaging (MRI) examination. Participants were requested not to smoke or drink tea or coffee for 30 minutes and to sit quietly for 10 minutes at least, before blood pressure and other hemodynamic parameters were measured. Individuals were considered hypertensive if they had systolic blood pressure (SBP) values > 150 mm Hg and/or diastolic blood pressure (DBP) values > 90 mm Hg or if they were previously diagnosed as hypertensive and treated with one or more antihypertensive drug.
- Being tested
- reactive hyperaemia index measurement
- Keywords
- endothelial dysfunction, elderly, arterial stiffness, pulse wave velocity, geroscience, vascular aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reactive hyperaemia index measurementDevice
Also called pulse wave velocity measurement
reactive hyperaemia index with EndoPAT®
Pulse wave velocity measurement with Sphygmocor®
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial dysfunction
RHI measurement
Measured: 20 minutes
Secondary outcomes (2)
pulse wave velocity
PWV measurement
Measured: 10 minutes
PAT signal QUALITY
2 operators
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 May 2018
- Primary completion31 Dec 2019
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laure JOLY, Central Hospital, Nancy, France
- Investigators
- Laure Joly, Professor, Principal investigator, University of Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651894
- Sponsor's protocol ID
- 2020PI228
- Acronym
- ENDY
- Status last verified
- Dec 2020
- First submitted
- 26 Nov 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Sectional Relation of Digital Vascular Function Measured by EndoPAT® in elderlY Patients to Arterial Stiffness
- ClinicalTrials.gov ID
- NCT04651894
- Acronym / sponsor ID
- ENDY / 2020PI228
- Keywords
- endothelial dysfunction, elderly, arterial stiffness, pulse wave velocity, geroscience, vascular aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 3 Dec 2020 (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.
Due to the aging of populations worldwide, we observe an increase of age-related diseases and loss of autonomy with consequent personal, social, medical and economic implications. The aging population is a target for geriatric medicine, necessitating the development of specific diagnostic and therapeutic approaches in order to estimate cardio vascular risk in these individuals.
It is thought that arterial stiffening and endothelial dysfunction are among the earliest vascular properties altered with the onset of cardiovascular disease. Moreover aging is characterized by progressive fragmentation and break down of the elastic components of the aortic media, which are partially replaced by highly cross-linked collagen leading to stiffening, dilation, and elongation of the aorta . A major underlying mechanism of these modifications is endothelial dysfunction due to high oxidative stress and low-grade inflammation. Reactive hyperemia index (RHI), a key outcome of peripheral arterial tonometry (PAT) has recently become a reliable tool to measure microvascular endothelial function. Some studies have recently demonstrated the interest to measure in elderly patients arterial stiffness parameters in order to prevent loss of autonomy. This cross sectional study aimed at demonstrating the link between arterial stiffness evaluated by pulse wave velocity and endothelial dysfunction evaluated by RHI to implement the tools of cardio vascular risk evaluation in a population of elderly patients referred in a geriatric day hospital.
Detailed description
This study is a cross sectional monocentric retrospective study in a geriatric day hospital population coming for frailty and cardio vascular evaluation : clinical data of 148 patients hospitalized from April 2018 to December 2019 (20 months) of the Measurement of the ARterial-Cardiac AGEing and prevention evaluation of FRailty (MARCAGE.FR) geriatric day hospital of Nancy were retrospectively analyzed. Eligible patients were those who had benefited from an EndoPAT® measurement and arterial stiffness evaluation and aged over 60 years. Exclusion criteria to analyze aortic pulse wave velocity was the presence of atrial fibrillation and for EndoPAT® a poor quality of the signal. 105 among these 148 patients were finally selected as they present EndoPAT® good signal (reviewed by two operators).
All subjects arrived in a fasting state at the geriatric day hospital where anthropometric, frailty evaluation, hemodynamic and transcutaneous measurements of aortic pulse wave velocity (AoPWV) were performed at rest. Some of them had a cerebral Magnetic resonance imaging (MRI) examination. Participants were requested not to smoke or drink tea or coffee for 30 minutes and to sit quietly for 10 minutes at least, before blood pressure and other hemodynamic parameters were measured. Individuals were considered hypertensive if they had systolic blood pressure (SBP) values > 150 mm Hg and/or diastolic blood pressure (DBP) values > 90 mm Hg or if they were previously diagnosed as hypertensive and treated with one or more antihypertensive drug.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 105 among these 148 patients were finally selected as they present ENDOPAT good signal
Key inclusion criteria (4 listed)
- age over 60 years
- referred to a day hospital check up
- arterial stiffness evaluation
- peripheral Arterial Tonometry Evaluation
Key exclusion criteria (2 listed)
- atrial fibrillation during examination
- poor quality of the signals
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 |
|---|---|---|
| reactive hyperaemia index measurementAlso: pulse wave velocity measurementreactive hyperaemia index with EndoPAT® Pulse wave velocity measurement with Sphygmocor® | Device | – |
Primary outcome
endothelial dysfunction
Time frame: 20 minutes
RHI measurement
2 secondary outcomes
pulse wave velocity
Time frame: 10 minutes
PAT signal QUALITY
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
Laure Joly, Professor principal investigator
University of Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Disease and Frail Elderly Syndrome, run by Central Hospital, Nancy, France at 1 site in France.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 dysfunction (time frame: 20 minutes). 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 4 Dec 2020.