Validation of Laser Doppler Vibrometer (LDV) for Measurement of Arterial Stiffness in Hypertensive Patients (CARDIS-PWV)

September 1, 2025 updated by: Institut National de la Santé Et de la Recherche Médicale, France
The aim is to compare a new technique for assessing local and regional arterial stiffness: the Laser Doppler Vibrometry with the reference techniques, the applanation tonometry and echotracking.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cardiovascular (CV) diseases and their risk factors are the major contributors to global morbidity and mortality. CV diseases are responsible for over 17.3 million deaths per year worldwide, representing 30% of all global deaths. The measurement of arterial stiffness during the medical investigation of a hypertensive subject is essential to estimate the overall CV risk. The European Society of Hypertension (ESH) and the European Society of Cardiology (ESC) working group recommend its use for CV risk assessment. Indeed, arterial stiffness is currently the subject of a scientific consensus due to the large number of pathophysiological, epidemiological and pharmacological studies demonstrating that it integrates the duration and the level of exposure of the patient to known and identified CV risk factors (hypertension, tobacco, diabetes...) as well as those still discussed or more difficult to quantify (low birth weight, inflammation, infection, genetics...).

Arterial stiffness can be assessed in a number of ways, but the non-invasive measurement of the carotid-femoral pulse wave velocity (cfPWV) by applanation tonometry is regarded as the current gold standard because it corresponds to the aortic stiffness and it has been widely validated in epidemiological studies. However, the routine measurement of PWV by applanation tonometry is technically demanding and uncomfortable for the patient because the sensors can be attached around the neck or involve a palpation of the groin. The more advanced devices for PWV assessment are bulky, require trained operators due to the complexity of the procedure, and are relatively expensive. Therefore, none of the devices available for measurement of PWV are suitable for use in primary care. Measurement of arterial stiffness at primary care would allow large population screening for CV risks and thus enable more accurate CV risk prediction to better target preventive therapy among those individuals considered to be at low or moderate risk according to current guidelines. However, the tools and devices available today do not allow for mobile, low-cost, reliable, fast and non- or minimally-invasive point-of-care screening for measurement of arterial stiffness.

PWV measurement by laser Doppler vibrometry, contactless, is more comfortable, acceptable and could thus be a substitute for applanation tonometry.

A laser Doppler vibrometer (LDV) is an instrument that is used to make non-contact vibration measurements of a surface. The laser beam from the LDV is directed at the surface of interest (in our case the skin covering the artery or the heart), and the vibration amplitude and frequency are extracted from the Doppler shift of the reflected laser beam frequency due to the motion of the surface. Preliminary data suggest that LDV can lead to an improved screening and assessment of CV risk as a technique that makes it possible to measure aortic and local PWV. Indeed, Ghent University has successfully demonstrated that aortic PWV can be correctly measured with LDV. This method will greatly simplify procedures for measuring aortic stiffness if it is available in a compact form and adapted to clinical practice. This is the purpose of the CARDIS project, H2020 (http://www.cardis-h2020.eu/), which aims to develop a compact device for measuring local and segmental arterial stiffness without contact to the skin thanks to the LDV technique. The objective of this study is to compare the CARDIS LDV prototype with the reference techniques, carotid-femoral and local carotid PWV.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Hopital Européen Georges Pompidou / Service de Pharmacologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with grade I-III essential arterial hypertension, recently diagnosed, well controlled or insufficiently equilibrated under stable antihypertensive treatment for their HTA

Exclusion Criteria:

  • Severe pathologies interfering with HTA or not allowing measurement by the techniques of interest, including skin diseases impeding the applanation tonometry
  • Allergies to ultrasound gel or to adhesive film

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hypertensives
PWV measurement by LDV
Device: PWV measurement by LDV
PWV measurement by LDV : carotid-femoral, carotid and chest-carotid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
carotid-femoral PWV measured by LDV
Time Frame: day 1
day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
carotid PWV measured by LDV
Time Frame: day 1
day 1
chest-carotid PWV measured by LDV
Time Frame: day 1
day 1
carotid-femoral PWV measured by applanation tonometry
Time Frame: day 1
day 1
carotid PWV measured by Echotracking
Time Frame: day 1
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pierre Boutouyrie, MD, PhD, Pharmacology Department - Hopital Européen Georges Pompidou - Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 4, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 4, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C17-43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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