Comparison of Ultrafast Echo With Echotracking

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Essential Untreated Hypertension

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting Essential untreated hypertension Healthy Volunteers

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Hypertension patients; Local common carotid artery pulse wave velocity is compared in patients with hypertension and healthy volunteers.
Healthy Volunteers; Local common carotid artery pulse wave velocity is compared in hypertension patients and healthy volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Local common carotid artery pulse wave velocity	Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Common carotid artery Young's modulus (Stiffness of wall material)	Day 1

Collaborators and Investigators

• Sponsor: French Cardiology Society
• Investigators: Principal Investigator: Stéphane Laurent, MD, PhD, Pharmacology Department - Hopital Européen Georges Pompidou - Paris

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: December 4, 2012
• First Submitted That Met QC Criteria: December 5, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Estimate): October 2, 2015
• Last Update Submitted That Met QC Criteria: October 1, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: stiffness; ultrasound imaging; Large arteries; intima media thickness
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 2012-01 (AP HM); ID - RCB 2012-A01255-38 (Other Identifier: ANSM)