Fragility and Programmed Cardiovascular Surgery (EcoSarco) (EcoSarco)
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|ClinicalTrials.gov Identifier: NCT04110509|
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : October 2, 2019
Objectives: To characterize textural ultrasonographic biomarkers of the brachial biceps musculature, wrist flexors, quadriceps and anterior tibial muscle that allow the recognition of the muscular and functional status of patients undergoing programmed cardiovascular surgery and relate them to mortality, hospital stay and functionality results after the intervention.
Design: A first phase of cross-sectional observational study and a second phase of longitudinal observational prospective study. Participants: Patients with programmed cardiovascular surgery to aortic valve replacement Outcomes: Sociodemographic and anthropometric variables, severity and clinical risk scales, disability, fragility and quality of life scales, nutritional status and textural muscular biomarkers with ultrasonography.
Expected results: strong association between ultrasound muscle biomarkers and ICU and hospital stay, disability, fragility and quality of life after the surgery.
|Condition or disease|
|Fragility Intensive Care Unit Syndrome|
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||Fragility and Programmed Cardiovascular Surgery: Development of Muscle Ultrasonographic Biomarkers of Sarcopenia and Post-surgical Results|
|Actual Study Start Date :||September 1, 2017|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||January 1, 2019|
- Changes in muscle ultrasonography variation after surgery [ Time Frame: 6 months ]Ultrasonography variation is a measure of the degree of heterogeneity of a ultrasonographic image which provides information on changes in tissue structure (muscles).
- Changes in muscle echointensity after surgery [ Time Frame: 6 months ]Echointensity is the average of echogenicity of a ultrasonographic image which provides information on changes in tissue structure
- Changes in muscle texture after surgery [ Time Frame: 6 months ]Muscle texture can be characterized by advanced image analysis algorithms such grey level co-occurrence matrices. In this case 5 textural parameters (uniformity, contrast, homogeneity, correlation and entropy) used together are used to characterize the tissue.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110509
|Madrid, Spain, 28036|