跳至主要内容
临床试验/NCT04549298
NCT04549298Unknown不适用

Assessment of the Possible Association Between Left Ventricular Diastolic Dysfunction and Carotid Atherosclerosis and Brain White Matter Damage

Neuromed IRCCS0 个研究点目标入组 88 人开始时间: 2022年10月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
88
主要终点
Measurement of white matter hyperintensities volume

研究概览

简要总结

Left ventricular diastolic dysfunction is caused by impaired relaxation and increased left ventricular stiffness with a consequent increase in filling pressures. Currently, it is possible to classify it in 3 grades: grade 1 with normal filling pressures, grade 2 and grade 3 with high pressures. Diastolic dysfunction is closely associated with several risk factors such as hypertension, diabetes, and obesity, as well as the risk of heart failure, cardiovascular events, and death. In the field of cerebrovascular diseases, however, diastolic dysfunction is still being researched. Thus, this study aims to: 1) evaluate the white matter hyperintensities volume in association with the increase of diastolic dysfunction and filling pressures 2) evaluate the possible association with carotid atherosclerosis in case of brain damage caused by dysfunction diastolic 3) understand the mechanism of damage caused by left ventricular diastolic dysfunction on the cerebrovascular system. In order to do this, this study proposes to evaluate in a cohort of patients, between 35 and 65 years, the possible association of diastolic dysfunction with lesions on the cerebrovascular system in a future view of new marker of brain damage and new modifiable risk factor.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age ≥ 35 and ≤ 65 years
  • written informed consent

排除标准

  • previous stroke or TIA
  • arrhythmia or severe cardiac disease
  • renal disease
  • psychiatric disease
  • neurological or neurodegenerative disease
  • previous carotid artery stenting or carotid surgery
  • inability to be subjected MRI analysis

结局指标

主要结局

Measurement of white matter hyperintensities volume

时间窗: At Enrollment

Brain MRI

次要结局

  • Characterization of cardiac overload with blood markers(At Enrollment)
  • Detection of plaques and carotid atherosclerosis(At Enrollment)
  • Detection of cognitive decline by decrease of MoCA score(At Enrollment)

研究者

发起方
Neuromed IRCCS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giuseppe Lembo

Full Professor, MD, PhD

Neuromed IRCCS

相似试验