NCT04651894

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
Last Updated

December 4, 2020

Status Verified

December 1, 2020

Enrollment Period

1.7 years

First QC Date

November 26, 2020

Last Update Submit

December 3, 2020

Conditions

Keywords

endothelial dysfunctionelderlyarterial stiffnesspulse wave velocitygerosciencevascular aging

Outcome Measures

Primary Outcomes (1)

  • endothelial dysfunction

    RHI measurement

    20 minutes

Secondary Outcomes (2)

  • pulse wave velocity

    10 minutes

  • PAT signal QUALITY

    10 minutes

Interventions

reactive hyperaemia index with EndoPAT® Pulse wave velocity measurement with Sphygmocor®

Also known as: pulse wave velocity measurement

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

105 among these 148 patients were finally selected as they present ENDOPAT good signal

You may qualify if:

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

You may not qualify if:

  • atrial fibrillation during examination
  • poor quality of the signals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, Lorraine, 54511, France

Location

Study Officials

  • Laure Joly, Professor

    University of Lorraine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 26, 2020

First Posted

December 3, 2020

Study Start

May 1, 2018

Primary Completion

December 31, 2019

Study Completion

November 3, 2020

Last Updated

December 4, 2020

Record last verified: 2020-12

Locations