Impact of the Central Blood Pressure Level in Cerebral Metabolic Aging: a 18F-FDG PET Study.
PACTEP
1 other identifier
interventional
92
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedStudy Start
First participant enrolled
July 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2020
CompletedAugust 24, 2022
August 1, 2022
2.3 years
November 10, 2017
August 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
volume of brain areas detected by quantitative analysis
At inclusion
topography of brain areas detected by quantitative analysis
At inclusion
central blood pressure
At inclusion
Study Arms (1)
Subjects
EXPERIMENTALSubjects 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.
Interventions
Positron Emission Tomography with a cerebral step before to carry out the standard Position Emission Tomography
Mini Mental State Examination, MMSE, Mini International Neuropsychiatric Interview MINI and Frontal Assessment Batery FAB
Eligibility Criteria
You may qualify if:
- \> 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.
You may not qualify if:
- "abnormal" neuropsychological tests:
- Mini Mental State Examination (MMSE) \<27,
- Current major depressive episode on the Mini International Neuropsychologic Interview (MINI),
- Frontal Assessment Battery (FAB) \<15.
- F-FDG PET examination showing ischemic, neurodegenerative, neoplastic or other brain lesions (independent of a normal or accelerated aging process).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU Nancy
Vandœuvre-lès-Nancy, 54511, France
Related Publications (1)
Hurstel M, Joly L, Imbert L, Zimmermann G, Roch V, Schoepfer P, Lamiral Z, Salvi P, Benetos A, Verger A, Marie PY. Volume of the proximal half of the thoracic aorta is the most comprehensive FDG-PET/CT indicator of arterial aging throughout adulthood. Eur J Hybrid Imaging. 2023 Jun 28;7(1):11. doi: 10.1186/s41824-023-00169-2.
PMID: 37369917DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antoine Verger, MD, PhD
CHRU Nancy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
November 10, 2017
First Posted
November 17, 2017
Study Start
July 31, 2018
Primary Completion
November 6, 2020
Study Completion
November 6, 2020
Last Updated
August 24, 2022
Record last verified: 2022-08