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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04110509
Other study ID # ECOSARCO_CARDIO v0.2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2017
Est. completion date January 1, 2019

Study information

Verified date September 2019
Source Universidad Antonio de Nebrija
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 1, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Spain Jose Rios-Diaz Madrid

Sponsors (1)

Lead Sponsor Collaborator
Universidad Antonio de Nebrija

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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