Healthy VolunteersULTRAFASTECHONCT01096264
Non-Invasive Quantitative Imaging of Human Local Arterial Wall Elasticity Using Supersonic Shear Imaging
A study testing SSI and SphygmoCor® evaluations in people with Healthy Volunteers and Vascular Ehlers Danlos Syndrome, run by French Cardiology Society at 1 site in France.
Trial summary
Arterial stiffness is associated with increased risk of cardiovascular events and death. Most of existing technique need dedicated device for arterial stiffness evaluation and indirect calculation of intra arterial pressure. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Vascular Ehlers Danlos Syndrome
- What is being tested?
- SSI and SphygmoCor® evaluations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers between 18 and 70 years old of two sexes.
- Caucasian origin
- No tobacco or stopped for more than 5 years
- BMI between 18 and 30 kg/m2.
- Blood pressure after 5 minutes of rest < 140 and 90 mmHg.
- Biological test (haematological biochemistry test in blood , urine test and toxicology tests are all normal) ECG, Blood pressure and Heart rhythm normal.
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- All volunteers received information on the research and signed the consent form.
- Health system protection required
- Age between, 18 et 70 years old for the two sexes
- Presence of two major criteria of Villefranche classification (Am J Med Genet 1998 ;77:31-7) and/or heterozygote pathogen mutation of COL3A1 gene.
- At least 4cm long normal arterial segment (carotid or femoral) analyzed by mode B echograph.
- All patient received information on the research and signed the consent form.
- Health system protection required
- General Exclusion Criteria :
- Pregnancy
- Echograph gel allergy
- Local Artery disease (dissection or thrombosis)
- Arrhythmia
- No health insurance coverage
- Incapacity or refused to sign the consent form
Who cannot join
- Acute or Chronic Systemic disease (atherosclerosis)
- Alcohol abuse or drug abuse (cocaine,cannabis,etc..)
- Active or past tobacco
- Hypercholesterolemia (LDLc >1.09 g/l)
- Exclusion period according to the national record for volunteer of clinical trial.
- No intact (carotid or femoral) segment for SSI analysis
- AT2 inhibitors or Beta blockers treatment will be notified but are not considered as exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishment of Local Arterial Stiffness Normal Values (Carotid and Femoral) on Healthy Volunteers Using Supersonic Shear Imaging
Arterial stiffness is associated with increased risk of cardiovascular events and death.
Most of existing technique need dedicated device for arterial stiffness evaluation and indirect calculation of intra arterial pressure. Supersonic Shear Imaging (SSI) is a novel non-invasive technique based on remote palpation of biological tissues that can image with very high temporal resolution (up to 10,000 images/s) and quantify the local viscoelastic properties of tissues. The investigators goal was to apply this SSI technique for arterial stiffness evaluation and local pulse wave velocity (PWV) calculation.
As a first step, the primary goal of this study is to establish normal values of local pulse wave velocity and arterial stiffness (carotid and femoral) by SSI on hundred healthy volunteers.
Read the detailed description
Provide a more extensive description, if desired. Avoid duplication of information to be recorded elsewhere, such as eligibility criteria or outcome measures.
- Being tested
- SSI and SphygmoCor® evaluations
- Keywords
- Arterial stiffness, Pulse wave velocity, Ultrafastecho, Supersonic shear imaging
- Medical subject headings
- Ehlers-Danlos Syndrome, Type IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSI and SphygmoCor® evaluationsOther
- SSI evaluation need Aixplorer vascular ultrasound machine (available in our department) with 8 MHz linear array probe applied on the carotid and femoral artery.
- SphygmoCor® evaluation used pressure captors on carotid and femoral sites to record the intra-arterial pressure wave time delay after QRS wave. After distance calculation between the two sites, Aortic PWV can be derived.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer | Other | Healthy volunteer undergoing two imagery evaluation :
* SSI technique for local PWV and arterial stiffness evaluation
* SphygmoCor® for aortic PWV. Receives: Other: SSI and SphygmoCor® evaluations |
| vEDS patients | Other | vEDS patients undergoing two imagery evaluations:
* SSI technique for local PWV and arterial stiffness evaluation
* SphygmoCor® for aortic PWV. Receives: Other: SSI and SphygmoCor® evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal Values by SSI
Normal Values by SSI of local PWV and arterial wall stiffness(carotid and femoral).
Measured: day one
Secondary outcomes (3)
repeatability of the "primary outcome measure"
Evaluation of the repeatability of the "primary outcome measure" on 100 healthy volunteers and 30 patients with Vascular Ehlers Danlos Syndrome (vEDS).
Measured: Day one
Comparison between 2 populations of values by SSI
Comparison between healthy volunteers and vEDS patients for PWV and arterial stiffness evaluated by SSI.
Measured: Day one
Comparison of values between SSI and standard gold
Concordance evaluation between PWV calculated by SSI and Aortic Pulse wave velocity calculated by ShygmoCor®
Measured: Day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France, SOCIETE FRANCAISE DE MEDECINE VASCULAIRE
- Investigators
- Emmanuel Messas, MD, Principal investigator, Hôpital Européen Georges-PompidouAnne Blanchard, MD, Study chair, Hôpital Européen Georges-PompidouJoseph Emmerich, MD, PhD, Study chair, Hôpital Européen Georges-PompidouXavier Jeunemaitre, MD, PhD, Study chair, Hôpital Européen Georges-PompidouMichael Franck, MD, Study chair, Hôpital Européen Georges-PompidouOlivier Steinchen, MD, Study chair, Hôpital Européen Georges-PompidouMichel Azizi, MD, PhD, Study chair, Hôpital Européen Georges-Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096264
- Sponsor's protocol ID
- 2009-03
- Acronym
- ULTRAFASTECHO
- Status last verified
- Mar 2015
- First submitted
- 19 Mar 2010
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Local Arterial Stiffness Normal Values (Carotid and Femoral) on Healthy Volunteers Using Supersonic Shear Imaging
- ClinicalTrials.gov ID
- NCT01096264
- Acronym / sponsor ID
- ULTRAFASTECHO / 2009-03
- Keywords
- Arterial stiffness, Pulse wave velocity, Ultrafastecho, Supersonic shear imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- National Research Agency, France, SOCIETE FRANCAISE DE MEDECINE VASCULAIRE
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 31 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Arterial stiffness is associated with increased risk of cardiovascular events and death.
Most of existing technique need dedicated device for arterial stiffness evaluation and indirect calculation of intra arterial pressure. Supersonic Shear Imaging (SSI) is a novel non-invasive technique based on remote palpation of biological tissues that can image with very high temporal resolution (up to 10,000 images/s) and quantify the local viscoelastic properties of tissues. The investigators goal was to apply this SSI technique for arterial stiffness evaluation and local pulse wave velocity (PWV) calculation.
As a first step, the primary goal of this study is to establish normal values of local pulse wave velocity and arterial stiffness (carotid and femoral) by SSI on hundred healthy volunteers.
Detailed description
Provide a more extensive description, if desired. Avoid duplication of information to be recorded elsewhere, such as eligibility criteria or outcome measures.
Study design
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer | Other | Other: SSI and SphygmoCor® evaluationsHealthy volunteer undergoing two imagery evaluation : * SSI technique for local PWV and arterial stiffness evaluation * SphygmoCor® for aortic PWV. |
| vEDS patients | Other | Other: SSI and SphygmoCor® evaluationsvEDS patients undergoing two imagery evaluations: * SSI technique for local PWV and arterial stiffness evaluation * SphygmoCor® for aortic PWV. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Healthy volunteers between 18 and 70 years old of two sexes.
- Caucasian origin
- No tobacco or stopped for more than 5 years
- BMI between 18 and 30 kg/m2.
- Blood pressure after 5 minutes of rest < 140 and 90 mmHg.
Key exclusion criteria (7 listed)
- Acute or Chronic Systemic disease (atherosclerosis)
- Alcohol abuse or drug abuse (cocaine,cannabis,etc..)
- Active or past tobacco
- Hypercholesterolemia (LDLc >1.09 g/l)
- Exclusion period according to the national record for volunteer of clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSI and SphygmoCor® evaluations* SSI evaluation need Aixplorer vascular ultrasound machine (available in our department) with 8 MHz linear array probe applied on the carotid and femoral artery. * SphygmoCor® evaluation used pressure captors on carotid and femoral sites to record the intra-arterial pressure wave time delay after QRS wave. After distance calculation between the two sites, Aortic PWV can be derived. | Other | Healthy volunteer, vEDS patients |
Primary outcome
Normal Values by SSI
Time frame: day one
Normal Values by SSI of local PWV and arterial wall stiffness(carotid and femoral).
3 secondary outcomes
repeatability of the "primary outcome measure"
Time frame: Day one
Comparison between 2 populations of values by SSI
Time frame: Day one
Comparison of values between SSI and standard gold
Time frame: Day one
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Messas, MD principal investigator
Hôpital Européen Georges-Pompidou
Anne Blanchard, MD study chair
Hôpital Européen Georges-Pompidou
Joseph Emmerich, MD, PhD study chair
Hôpital Européen Georges-Pompidou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SSI and SphygmoCor® evaluations in people with Healthy Volunteers and Vascular Ehlers Danlos Syndrome, run by French Cardiology Society at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normal Values by SSI (time frame: day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2015.