Fragility and Programmed Cardiovascular Surgery (EcoSarco)

NCT04110509 | Completed

• 1 other identifier: ECOSARCO_CARDIO v0.2
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Fragility; Intensive Care Unit Syndrome

Keywords

Imaging biomarkers; Ultrasonography; Fragility; Intensive Care Unit

Outcome Measures

Primary Outcomes (3)

• Changes in muscle ultrasonography variation after surgery

  Ultrasonography variation is a measure of the degree of heterogeneity of a ultrasonographic image which provides information on changes in tissue structure (muscles).

  6 months

• Changes in muscle echointensity after surgery

  Echointensity is the average of echogenicity of a ultrasonographic image which provides information on changes in tissue structure

  6 months

• Changes in muscle texture after surgery

  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.

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Antonio de Nebrija: lead

Study Sites (1)

Jose Rios-Diaz

Madrid, 28036, Spain

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in Biology, Physical Therapist

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: October 1, 2019
• Study Start: September 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: January 1, 2019
• Last Updated: October 2, 2019

Record last verified: 2019-09

Locations

ES (1)