Fragility and Programmed Cardiovascular Surgery (EcoSarco)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04110509

Acronym

EcoSarco

Enrollment

Registered

2019-10-01

Start date

2017-09-01

Completion date

2019-01-01

Last updated

2019-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fragility, Intensive Care Unit Syndrome

Keywords

Imaging biomarkers, Ultrasonography, Fragility, Intensive Care Unit

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Changes in muscle ultrasonography variation after surgery	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	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	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.

Countries

Spain

Outcome results