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Fragility and Programmed Cardiovascular Surgery (EcoSarco) (EcoSarco)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110509
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
José Ríos-Díaz, Universidad Antonio de Nebrija

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. 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).

  2. 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

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who are admitted to the Intensive Care Unit of the Hospital Clínico Universitario Virgen de la Arrixaca de Murcia (HCUVAM) and the Hospital Universitario del Vinalopó de Elche (HUVE) for surgery programmed cardiovascular, specifically aortic valve replacement.
Criteria

Inclusion Criteria:

  • Waiting list patients with cardiovascular surgery scheduled for aortic valve refill

Exclusion Criteria:

  • Urgency while waiting list
  • Patients with no evaluation by presurgery committee
  • Previous diagnosis of neuropathies, radiculopathy, polyneuropathy congenital or acquired or pathologies with muscular affectation

Information from the National Library of Medicine

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


Locations
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Spain
Jose Rios-Diaz
Madrid, Spain, 28036
Sponsors and Collaborators
Universidad Antonio de Nebrija
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Responsible Party: José Ríos-Díaz, PhD in Biology, Physical Therapist, Universidad Antonio de Nebrija
ClinicalTrials.gov Identifier: NCT04110509    
Other Study ID Numbers: ECOSARCO_CARDIO v0.2
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by José Ríos-Díaz, Universidad Antonio de Nebrija:
Imaging biomarkers
Ultrasonography
Fragility
Intensive Care Unit