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临床试验/NCT04110509
NCT04110509已完成不适用

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

Universidad Antonio de Nebrija1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Changes in muscle ultrasonography variation after surgery

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Changes in muscle ultrasonography variation after surgery

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Universidad Antonio de Nebrija
申办方类型
Other
责任方
Principal Investigator
主要研究者

José Ríos-Díaz

PhD in Biology, Physical Therapist

Universidad Antonio de Nebrija

研究点 (1)

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