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临床试验/NCT03345290
NCT03345290已完成不适用

Impact of the Central Blood Pressure Level in Cerebral Metabolic Aging: a 18F-FDG PET Study.

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2018年7月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
92
试验地点
1
主要终点
volume of brain areas detected by quantitative analysis

研究概览

简要总结

Cerebral glycolytic metabolism can be quantified by quantitative analysis of 18F-Fluorodeoxyglucose (18F-FDG) Positron Emission Tomography (PET). This allows to identify neurological diseases at an early stage of functional abnormalities, before any anatomical lesions, and to differentiate them from the "normal" brain aging. Aging mainly leads to atrophy with a decrease in cerebral metabolism in the prefrontal cortex, with consequent deterioration of cognitive processes, in particular executive functions (5).

In a population of 92 "control" subjects, investigators have already quantified the importance of the aging in frontal cortex hypometabolism. These patients were referred for a 18F-FDG PET in the follow-up of lymphoma considered to be in complete remission (PET without cerebral step), without any chemoradiotherapy within 2 months and with normal neuropsychological tests (Mini Mental State Examination, MMSE, Mini International Neuropsychiatric Interview MINI and Frontal Assessment Battery FAB).

However, cerebral aging can be "accelerated" by vascular risk factors, including increased central blood pressure, as investigators have recently reported in a pilot study involving elderly patients. This central pressure, which is directly linked to the cerebral micro-vascularization, can be easily measured by applanation tonometry. In this pilot study, investigators showed that a central pulse pressure equal or greater than 50 mmHg was associated with a significant frontal hypometabolism in elderly patients. This confirmed, at a stage of pre-clinical remodeling, the worse prognostic significance for this criterion, as reported in large epidemiological studies (increased risk of stroke and cardiac vascular events).

However, it is not yet known whether the level of central blood pressure interfere with the brain metabolism of younger subjects, especially with regard to aging observed throughout life. If this hypothesis is confirmed, preventive therapeutic strategies for accelerated aging, could thus integrate the monitoring of central pressure and cerebral metabolism.

The objective of this study is to determine, in a population of control subjects and on a larger scale, the impact of central blood pressure on brain metabolic aging , by using 18F-FDG PET.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • •> 18 years old, with written informed consent,
  • •Subjects referred for 18F-FDG PET in a non-oncological setting,
  • •Absence of pregnancy or breastfeeding,
  • •Lack of chemotherapy in the previous year and no cerebral radiotherapy.
  • •No history of psychiatric or neurological pathology.
  • •Absence of treatment with psychotropic action, and absence of corticosteroids.

排除标准

  • •"abnormal" neuropsychological tests:
  • •Mini Mental State Examination (MMSE) <27,
  • •Current major depressive episode on the Mini International Neuropsychologic Interview (MINI),
  • •Frontal Assessment Battery (FAB) <
  • •18F-FDG PET examination showing ischemic, neurodegenerative, neoplastic or other brain lesions (independent of a normal or accelerated aging process).

研究组 & 干预措施

Subjects

Experimental

Subjects referred to a FDG PET scan (standard PET without cerebral step) without any oncologic setting. Patients will be included as following critera: 25% of subjects will have under 40 years old, 25% between 40 and 60 yeard old et 50% higher than 60 years old.

干预措施: PET with a cerebral step (Device)

Subjects

Experimental

Subjects referred to a FDG PET scan (standard PET without cerebral step) without any oncologic setting. Patients will be included as following critera: 25% of subjects will have under 40 years old, 25% between 40 and 60 yeard old et 50% higher than 60 years old.

干预措施: Central blood pressure measurement (Device)

Subjects

Experimental

Subjects referred to a FDG PET scan (standard PET without cerebral step) without any oncologic setting. Patients will be included as following critera: 25% of subjects will have under 40 years old, 25% between 40 and 60 yeard old et 50% higher than 60 years old.

干预措施: Neurocognitive tests (Other)

结局指标

主要结局

volume of brain areas detected by quantitative analysis

时间窗: At inclusion

topography of brain areas detected by quantitative analysis

时间窗: At inclusion

central blood pressure

时间窗: At inclusion

次要结局

未报告次要终点

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antoine VERGER

MD, PhD

Central Hospital, Nancy, France

研究点 (1)

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