Relationship Between Digital Vascular Function Measured by EndoPAT® in elderlY Patients and Arterial Stiffness

NCT ID: NCT04651894

Last Updated: 2020-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

148 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-01

Study Completion Date

2020-11-03

Brief Summary

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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

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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.

Conditions

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Arterial Disease Frail Elderly Syndrome Stiffness, Vascular Endothelial Degeneration

Keywords

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endothelial dysfunction elderly arterial stiffness pulse wave velocity geroscience vascular aging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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reactive hyperaemia index measurement

reactive hyperaemia index with EndoPAT®

Pulse wave velocity measurement with Sphygmocor®

Intervention Type DEVICE

Other Intervention Names

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pulse wave velocity measurement

Eligibility Criteria

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Inclusion Criteria

* age over 60 years
* referred to a day hospital check up
* arterial stiffness evaluation
* peripheral Arterial Tonometry Evaluation

Exclusion Criteria

* atrial fibrillation during examination
* poor quality of the signals
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Laure JOLY

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laure Joly, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Lorraine

Locations

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CHRU Nancy

Vandœuvre-lès-Nancy, Lorraine, France

Site Status

Countries

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France

Other Identifiers

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2020PI228

Identifier Type: -

Identifier Source: org_study_id