Comparison of Ultrafast Echo With Echotracking

Healthy Volunteers Clinical Trial

Official title:

Protocole ULTRAFAST - ECHOTRACKING : Remodelage pariétal et rigidité artérielle Chez l'Hypertendu : Nouvelle étude de Leur Relation Utilisant l'élastographie Par Ultrafast-écho et la séparation Intima/média Par écho-tracking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743352
• Other study ID #: 2012-01
• Secondary ID: ID - RCB 2012-A0
• Status: Completed
• Phase: N/A
• First received: December 4, 2012
• Last updated: October 1, 2015
• Start date: March 2013
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial Summary

The aim is to compare a new technique for assessing mechanical properties of large arteries: the Ultrafast echo with the reference technique, the echotracking. This will be done by studying in parallel hypertensive patients and controls with both techniques and this will revisit old concepts of increased stiffness in hypertensive arteries.

Description:

Ultrafast ECHO is a new non invasive method for assessing stiffness of living tissues. It takes advantage of very fast imaging technologies (up to 20 000 images/sec) to measure the diffusion of pressure waves in the tissues. This pressure wave can be either natural (blood pressure), or generated by an very short ultrasonic impulsion at a given place. By using both modes, it is possible to have a precise cartography of tissue mechanical properties. This technique is applied to solid tissues such as breast or liver, but not yet currently to hollow tissues such as arteries. The aim of the present study is to compare the values of stiffness obtained with Ultrafast ECHO with the reference non invasive technique, the Echotracking, which measures stiffness by assessing the deformation of arteries in response to changes in blood pressure. On the physiological part, we will revisit old concepts of increased stiffness of hypertensive's arteries. Indeed, hypertension is associated with increased stiffness due to recruitement of collagen fibers, but also to chronic remodelling. We have shown before that this remodelling conducts to accumulation of arterial tissue of lesser intrinsic stiffness. The latter finding was done through models based on echotracking measurements. It will be interesting to see whether it holds true when stiffness is directly measured.

Sixty subjects (30 normotensive and30 hypertensives) will be included and studied once. Measurement will be performed in random order 3 time on the common carotid artery on both sides. Aortic stiffness will be measured by pulse wave velocity

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: August 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• hypertension,

• essential (WHO workup),

• untreated (> 28 days of treatment interruption, < 6 months of treatment) on insufficiently equilibrated (BP > 140 and/or 90 mmHg)

Exclusion Criteria:

• Any concomitant severe disease compromising patient's participation or compliance

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Essential Untreated Hypertension
• Healthy Volunteers

Locations

Country	Name	City	State
France	Hopital Européen Georges Pompidou / Service de Pharmacologie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
French Cardiology Society

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local common carotid artery pulse wave velocity		Day 1	No
Secondary	Common carotid artery Young's modulus (Stiffness of wall material)		Day 1	No