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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

Tracking Information
First Submitted Date September 25, 2019
First Posted Date October 1, 2019
Last Update Posted Date October 2, 2019
Actual Study Start Date September 1, 2017
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 30, 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.
Original Primary Outcome Measures
 (submitted: September 27, 2019)
  • Changes in muscle echovariation after surgery [ Time Frame: 6 months ]
    Echovariation 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, correlacion and entropy) used together are used to characterize the tissue.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fragility and Programmed Cardiovascular Surgery (EcoSarco)
Official Title Fragility and Programmed Cardiovascular Surgery: Development of Muscle Ultrasonographic Biomarkers of Sarcopenia and Post-surgical Results
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Fragility
  • Intensive Care Unit Syndrome
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 27, 2019)
50
Original Actual Enrollment Same as current
Actual Study Completion Date January 1, 2019
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04110509
Other Study ID Numbers ECOSARCO_CARDIO v0.2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party José Ríos-Díaz, Universidad Antonio de Nebrija
Study Sponsor Universidad Antonio de Nebrija
Collaborators Not Provided
Investigators Not Provided
PRS Account Universidad Antonio de Nebrija
Verification Date September 2019