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Completed

NCT Number: NCT04110509

Fragility and Programmed Cardiovascular Surgery (EcoSarco)

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.

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Key information

Conditions

Fragility Intensive Care Unit Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jose Rios-Diaz

Madrid, 28036, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidad Antonio de Nebrija

Other

Registry information

Official study title

Fragility and Programmed Cardiovascular Surgery: Development of Muscle Ultrasonographic Biomarkers of Sarcopenia and Post-surgical Results

Acronym: EcoSarco

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Oct 1, 2019
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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