Validation of Laser Doppler Vibrometer (LDV) for Measurement of Arterial Stiffness in Hypertensive Patients (CARDIS-PWV)
Primary Purpose
Hypertension
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PWV measurement by LDV
Sponsored by

About this trial
This is an interventional other trial for Hypertension focused on measuring arterial stiffness, pulse wave velocity, laser Doppler vibrometry
Eligibility Criteria
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
Sites / Locations
- Hopital Européen Georges Pompidou / Service de Pharmacologie
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hypertensives
Arm Description
PWV measurement by LDV
Outcomes
Primary Outcome Measures
carotid-femoral PWV measured by LDV
Secondary Outcome Measures
carotid PWV measured by LDV
chest-carotid PWV measured by LDV
carotid-femoral PWV measured by applanation tonometry
carotid PWV measured by Echotracking
Full Information
NCT ID
NCT03446430
First Posted
February 19, 2018
Last Updated
September 23, 2019
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT03446430
Brief Title
Validation of Laser Doppler Vibrometer (LDV) for Measurement of Arterial Stiffness in Hypertensive Patients
Acronym
CARDIS-PWV
Official Title
Validation of Laser Doppler Vibrometer (LDV) for Measurement of Arterial Stiffness in Hypertensive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 21, 2018 (Actual)
Primary Completion Date
December 4, 2018 (Actual)
Study Completion Date
December 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
arterial stiffness, pulse wave velocity, laser Doppler vibrometry
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypertensives
Arm Type
Experimental
Arm Description
PWV measurement by LDV
Intervention Type
Device
Intervention Name(s)
PWV measurement by LDV
Intervention Description
PWV measurement by LDV : carotid-femoral, carotid and chest-carotid
Primary Outcome Measure Information:
Title
carotid-femoral PWV measured by LDV
Time Frame
day 1
Secondary Outcome Measure Information:
Title
carotid PWV measured by LDV
Time Frame
day 1
Title
chest-carotid PWV measured by LDV
Time Frame
day 1
Title
carotid-femoral PWV measured by applanation tonometry
Time Frame
day 1
Title
carotid PWV measured by Echotracking
Time Frame
day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Boutouyrie, MD, PhD
Organizational Affiliation
Pharmacology Department - Hopital Européen Georges Pompidou - Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Européen Georges Pompidou / Service de Pharmacologie
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Validation of Laser Doppler Vibrometer (LDV) for Measurement of Arterial Stiffness in Hypertensive Patients
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