Contrast Enhanced Ultrasound and Muscle (Echomuscle)
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ClinicalTrials.gov Identifier: NCT02128750 |
Recruitment Status :
Completed
First Posted : May 1, 2014
Last Update Posted : March 7, 2016
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Sponsor:
University Hospital, Grenoble
Information provided by (Responsible Party):
University Hospital, Grenoble
Tracking Information | ||||
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First Submitted Date ICMJE | April 29, 2014 | |||
First Posted Date ICMJE | May 1, 2014 | |||
Last Update Posted Date | March 7, 2016 | |||
Study Start Date ICMJE | February 2011 | |||
Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Contrast Enhanced Ultrasound and Muscle | |||
Official Title ICMJE | Echographie de Contraste Pour l'Analyse de la Perfusion Musculaire Dans l'ischémie Critique | |||
Brief 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 therapeutics. | |||
Detailed Description |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE | Other: contrast echographie with hexafluorur of sulfur
Echography of contrast after injection of product of contrast (sonovue (r))
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Study Arms ICMJE | Experimental: revascularization group
Subjects in this arms have an contrast echographie with sonovue(r) then a revascularization and finnaly an other contrast echographie with sonovue.
Intervention: Other: contrast echographie with hexafluorur of sulfur
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
32 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | March 2014 | |||
Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02128750 | |||
Other Study ID Numbers ICMJE | EBCS1 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University Hospital, Grenoble | |||
Study Sponsor ICMJE | University Hospital, Grenoble | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | University Hospital, Grenoble | |||
Verification Date | April 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |