Fragility and Programmed Cardiovascular Surgery (EcoSarco) (EcoSarco)

• ClinicalTrials.gov Identifier: NCT04110509
• Recruitment Status: Completed
• First Posted: October 1, 2019
• Last Update Posted: October 2, 2019
• Sponsor: Universidad Antonio de Nebrija
• 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.

• 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

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

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