Frail Elderly Syndrome Clinical Trial
— ENDYOfficial title:
Cross Sectional Relation of Digital Vascular Function Measured by EndoPAT® in elderlY Patients to Arterial Stiffness
NCT number | NCT04651894 |
Other study ID # | 2020PI228 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | November 3, 2020 |
Verified date | December 2020 |
Source | Central Hospital, Nancy, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 148 |
Est. completion date | November 3, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHRU Nancy | Vandœuvre-lès-Nancy | Lorraine |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | endothelial dysfunction | RHI measurement | 20 minutes | |
Secondary | pulse wave velocity | PWV measurement | 10 minutes | |
Secondary | PAT signal QUALITY | 2 operators | 10 minutes |
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