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Clinical Trials/NCT03345290
NCT03345290CompletedNot Applicable

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

Central Hospital, Nancy, France1 site in 1 country92 target enrollmentStarted: July 31, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
92
Locations
1
Primary Endpoint
volume of brain areas detected by quantitative analysis

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •> 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.

Exclusion Criteria

  • •"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).

Arms & Interventions

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.

Intervention: 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.

Intervention: 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.

Intervention: Neurocognitive tests (Other)

Outcomes

Primary Outcomes

volume of brain areas detected by quantitative analysis

Time Frame: At inclusion

topography of brain areas detected by quantitative analysis

Time Frame: At inclusion

central blood pressure

Time Frame: At inclusion

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Central Hospital, Nancy, France
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Antoine VERGER

MD, PhD

Central Hospital, Nancy, France

Study Sites (1)

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