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Comparison of Ultrafast Echo With Echotracking

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by French Cardiology Society
Sponsor:
Information provided by (Responsible Party):
French Cardiology Society
ClinicalTrials.gov Identifier:
NCT01743352
First received: December 4, 2012
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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.


Condition
Essential Untreated Hypertension
Healthy Volunteers

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • Local common carotid artery pulse wave velocity [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Common carotid artery Young's modulus (Stiffness of wall material) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients presenting Essential untreated hypertension Healthy Volunteers

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743352

Contacts
Contact: Stéphane Laurent, MD, PhD (33) 1 56 09 39 91 stephane.laurent@egp.aphp.fr
Contact: Pierre Boutouyrie, MD, PhD (33) 1 56 09 39 66 pierre.boutouyrie@egp.aphp.fr

Locations
France
Hopital Européen Georges Pompidou / Service de Pharmacologie Recruiting
Paris, France, 75015
Contact: Stéphane Laurent, MD, PhD    +33 (1).56.09.39.91    stephane.laurent@egp.aphp.fr   
Contact: Pierre Boutouyrie, MD, PhD    33 1 56 09 39 66    pierre.boutouyrie@egp.aphp.fr   
Principal Investigator: Stéphane Laurent, MD, PhD         
Sub-Investigator: Pierre Boutouyrie, MD, PhD         
Sub-Investigator: Michel Azizi, MD, PhD         
Sub-Investigator: Anne Blanchard, MD         
Sub-Investigator: Marie Briet, MD         
Sub-Investigator: Aurélien Lorthioir, MD         
Sponsors and Collaborators
French Cardiology Society
Investigators
Principal Investigator: Stéphane Laurent, MD, PhD Pharmacology Department - Hopital Européen Georges Pompidou - Paris
  More Information

No publications provided

Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT01743352     History of Changes
Other Study ID Numbers: 2012-01, ID - RCB 2012-A01255-38
Study First Received: December 4, 2012
Last Updated: October 8, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by French Cardiology Society:
Large arteries
stiffness
intima media thickness
ultrasound imaging

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014