IschemiaEchomuscleNCT02128750
Contrast Enhanced Ultrasound and Muscle
A study testing contrast echographie with hexafluorur of sulfur in people with Ischemia and Thromboangiitis Obliterans, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The primary objective of our work is to show that quantification of muscular microvascularisation evaluated by injection of contrast agent is different between chronic critical limb ischemia (before revascularization) and after (healing of ischemia) and thus make the proof of its utility in evaluation of PAD… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemia, Thromboangiitis Obliterans
- What is being tested?
- contrast echographie with hexafluorur of sulfur
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to Mar 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over 40 years
- Patients with chronic critical limb ischemia as defined by consensus TASC 2 and eligible to a revascularisation
- Objective evaluation of critical ischemia is based on ankle pressure < 70 mm Hg or toe pressure < 50 mm Hg for patients with ulcer or pressure ankle pressure < 50 mm Hg or toe pressure < 30 mm Hg for patients with rest pain.
- Patient's consent signed
Who cannot join
- Patients under 18
- Pregnant or breast feeding woman
- Burger's disease
- Contra- indication to use of contrast
- Hypersensitivity to sulfurhexafluorure
- Unstable coronary heart disease, acute stroke, uncompensated heart failure
Show all 12Show fewer
- Right to left shunt
- Serious pulmonary hypertension (> 90 mm Hg)
- Uncontroled increased blood pressure
- Acute respiratory distress syndrom
- Consent refused
- Patients with leg wounds preventing ultrasonography
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Echographie de Contraste Pour l'Analyse de la Perfusion Musculaire Dans l'ischémie Critique
The primary objective of our work is to show that quantification of muscular microvascularisation evaluated by injection of contrast agent is different between chronic critical limb ischemia (before revascularization) and after (healing of ischemia) and thus make the proof of its utility in evaluation of PAD therapeutics.
Read the detailed description
- Peripheral arterial disease (PAD) is a frequent disease the incidence of which in men is about 32.5°/°° before 40 years and 71°/°° after 50 years. Prevalence of the disease increases with age to reach 3.7% of 60 to 69 year old subjects (Kannel 1970, 1985, Bloch 1985).
- Critical limb ischemia (CLI) ischemia is defined by typical chronic ischemic rest pain or ischemic skin lesions either ulcers or gangrene for more than two weeks (Norgren). Incidence is about 500 - 1000 / 106 / year in Europe and United states. Critical limb ischemia concerns 15 - 20% of patients with intermittent claudication (Eneroth 1992, Taylor 1989). Development can lead to limb loss with a frequency estimated between 7% at 5 years to 12% at 10 years. Problem is crucial for patients who cannot benefit from revascularization. Results of single medical treatments are uncertain. Development of neovascularisation by innovating therapeutic (autolog cell stem grafts, intramuscular growth factor injections ) represent an exciting and promising field of research.
- Peripheral arterial disease evaluation and staging are based on measures of resting ankle pressures, diagnosis of stenosis and obliteration (duplex, angiography, computed tomography scan and magnetic resonance imaging) and on measure of microcirculatory skin perfusion by Tc PO2. On the other hand, there is no simple tool to measure muscular microvascularisation whereas muscles suffer from ischemia in the same way as skin and nerves. Measures of muscular perfusion can be performed by Tc 99, magnetic resonance imaging but this is not used in clinical practice. CEUS used in routine to assess hepatic microvascularisation has recently been shown to be potentially useful to study muscle (Kramer 2008, Weber 2007).
- Ultrasonic contrast agents are intravascular microbubbles which used at low mechanical index generate harmonics and allow real time imaging in ultrasonography. Their use allows study of parenchyma enhancement in real time, notably of liver and kidneys; they are also used in practice to differentiate benign and malign tumors (Correas 2009). Correlations have been shown between muscle enhancement studied by CEUS and histologic data of capillary vascularisation (Weber 2005). More recently some authors have shown that CEUS may allow to differentiate patients with PAD at a stage of intermittent claudication and patients without PAD (Duerschmied 2006).Very few studies have studied patients with CLI. Duerschmied and all have shown that kinetic data of muscle enhancement may reflect collateral circulation developed in reaction to chronic ischemia. CEUS may be used to study muscular perfusion in the same way as TcPO2 reflects cutaneous vascularisation and may become an evaluation criteria of PAD therapeutics in a near future.
- We propose to study muscular perfusion by CEUS in patients with critical limb ischemia eligible to revascularization (PTA or bypass) before and after revascularization. Microbubbles injection leads to an increase in muscle echogenicity in two sequences: a rapid phase 15-20 s after injection (arteriolar filling) then a more intense second phase (veinular and capillary filling) (Duerschmied 2006). These two phases may be described by measures of acoustic intensity function of time and in particular time to peak (TTP), area under the curve (AUC). Time to peak seems to be the more reliable criteria (Duerschmied).
- Conditions
- Ischemia, Thromboangiitis Obliterans
- Being tested
- contrast echographie with hexafluorur of sulfur
- Medical subject headings
- Ischemia, Thromboangiitis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast echographie with hexafluorur of sulfurOther
Echography of contrast after injection of product of contrast (sonovue (r))
| Study group | Role | What they receive |
|---|---|---|
| revascularization group | Experimental | Subjects in this arms have an contrast echographie with sonovue(r) then a revascularization and finnaly an other contrast echographie with sonovue. Receives: Other: contrast echographie with hexafluorur of sulfur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Peak
Time to peak modification, before and one month after the revascularization
Measured: M0 (before revascularisation) and M1 (One month after the revascularisation).
Secondary outcomes (3)
Curves datas
Evaluation of other data issued from the kinetic curve of enhancement (time between injection and peak, area under curve, quantitative value of peak, time of vein-muscle transit (TTP muscle -TTP vein) before and after revascularization.
Measured: M0 (before revascularisation) M1 (one month after revascularisation).
kinetics values
Study of correlation between kinetic data (TTP) and measures of TcPO2 and toe systolic pressure before revascularization and one month after revascularization
Measured: M0 (before revascularisation) and M1 (one month after revascularisation).
Time to peak
Study of predictive value of TTP before revascularization on success of revascularization at 1 month (clinical evaluation on pain, lack of minor or major amputation, healing of ulcer) and at 3 months (survival, lack of minor or major amputation, new surgery).
Measured: M0, M1 and M3 (three month after revascularisation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startFeb 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IschemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe Seinturier, Doctor, Principal investigator, University Hospital Grenoble - Medecine vasculaire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128750
- Sponsor's protocol ID
- EBCS1
- Acronym
- Echomuscle
- Status last verified
- Apr 2014
- First submitted
- 29 Apr 2014
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echographie de Contraste Pour l'Analyse de la Perfusion Musculaire Dans l'ischémie Critique
- ClinicalTrials.gov ID
- NCT02128750
- Acronym / sponsor ID
- Echomuscle / EBCS1
- Conditions
- Ischemia, Thromboangiitis Obliterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 1 May 2014 (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.
The primary objective of our work is to show that quantification of muscular microvascularisation evaluated by injection of contrast agent is different between chronic critical limb ischemia (before revascularization) and after (healing of ischemia) and thus make the proof of its utility in evaluation of PAD therapeutics.
Detailed description
- Peripheral arterial disease (PAD) is a frequent disease the incidence of which in men is about 32.5°/°° before 40 years and 71°/°° after 50 years. Prevalence of the disease increases with age to reach 3.7% of 60 to 69 year old subjects (Kannel 1970, 1985, Bloch 1985).
- Critical limb ischemia (CLI) ischemia is defined by typical chronic ischemic rest pain or ischemic skin lesions either ulcers or gangrene for more than two weeks (Norgren). Incidence is about 500 - 1000 / 106 / year in Europe and United states. Critical limb ischemia concerns 15 - 20% of patients with intermittent claudication (Eneroth 1992, Taylor 1989). Development can lead to limb loss with a frequency estimated between 7% at 5 years to 12% at 10 years. Problem is crucial for patients who cannot benefit from revascularization. Results of single medical treatments are uncertain. Development of neovascularisation by innovating therapeutic (autolog cell stem grafts, intramuscular growth factor injections ) represent an exciting and promising field of research.
- Peripheral arterial disease evaluation and staging are based on measures of resting ankle pressures, diagnosis of stenosis and obliteration (duplex, angiography, computed tomography scan and magnetic resonance imaging) and on measure of microcirculatory skin perfusion by Tc PO2. On the other hand, there is no simple tool to measure muscular microvascularisation whereas muscles suffer from ischemia in the same way as skin and nerves. Measures of muscular perfusion can be performed by Tc 99, magnetic resonance imaging but this is not used in clinical practice. CEUS used in routine to assess hepatic microvascularisation has recently been shown to be potentially useful to study muscle (Kramer 2008, Weber 2007).
- Ultrasonic contrast agents are intravascular microbubbles which used at low mechanical index generate harmonics and allow real time imaging in ultrasonography. Their use allows study of parenchyma enhancement in real time, notably of liver and kidneys; they are also used in practice to differentiate benign and malign tumors (Correas 2009). Correlations have been shown between muscle enhancement studied by CEUS and histologic data of capillary vascularisation (Weber 2005). More recently some authors have shown that CEUS may allow to differentiate patients with PAD at a stage of intermittent claudication and patients without PAD (Duerschmied 2006).Very few studies have studied patients with CLI. Duerschmied and all have shown that kinetic data of muscle enhancement may reflect collateral circulation developed in reaction to chronic ischemia. CEUS may be used to study muscular perfusion in the same way as TcPO2 reflects cutaneous vascularisation and may become an evaluation criteria of PAD therapeutics in a near future.
- We propose to study muscular perfusion by CEUS in patients with critical limb ischemia eligible to revascularization (PTA or bypass) before and after revascularization. Microbubbles injection leads to an increase in muscle echogenicity in two sequences: a rapid phase 15-20 s after injection (arteriolar filling) then a more intense second phase (veinular and capillary filling) (Duerschmied 2006). These two phases may be described by measures of acoustic intensity function of time and in particular time to peak (TTP), area under the curve (AUC). Time to peak seems to be the more reliable criteria (Duerschmied).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| revascularization group | Experimental | Other: contrast echographie with hexafluorur of sulfurSubjects in this arms have an contrast echographie with sonovue(r) then a revascularization and finnaly an other contrast echographie with sonovue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women over 40 years
- Patients with chronic critical limb ischemia as defined by consensus TASC 2 and eligible to a revascularisation
- Objective evaluation of critical ischemia is based on ankle pressure < 70 mm Hg or toe pressure < 50 mm Hg for patients with ulcer or pressure ankle pressure < 50 mm Hg or toe pressure < 30 mm Hg for patients with rest pain.
- Patient's consent signed
Key exclusion criteria (12 listed)
- Patients under 18
- Pregnant or breast feeding woman
- Burger's disease
- Contra- indication to use of contrast
- Consent refused
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 |
|---|---|---|
| contrast echographie with hexafluorur of sulfurEchography of contrast after injection of product of contrast (sonovue (r)) | Other | revascularization group |
Primary outcome
Time to Peak
Time frame: M0 (before revascularisation) and M1 (One month after the revascularisation).
Time to peak modification, before and one month after the revascularization
3 secondary outcomes
Curves datas
Time frame: M0 (before revascularisation) M1 (one month after revascularisation).
kinetics values
Time frame: M0 (before revascularisation) and M1 (one month after revascularisation).
Time to peak
Time frame: M0, M1 and M3 (three month after revascularisation)
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 7 Mar 2016.
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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.
Christophe Seinturier, Doctor principal investigator
University Hospital Grenoble - Medecine vasculaire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing contrast echographie with hexafluorur of sulfur in people with Ischemia and Thromboangiitis Obliterans, run by University Hospital, Grenoble 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 4 inclusion and 12 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 7 Mar 2016. 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?
Time to Peak (time frame: M0 (before revascularisation) and M1 (One month after the revascularisation).). 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 7 Mar 2016.