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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Completed
CT.gov ID
NCT03345290
Collaborator
(none)
92
Enrollment
1
Location
1
Arm
27.2
Actual Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: PET with a cerebral step
  • Device: Central blood pressure measurement
  • Other: Neurocognitive tests
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
92 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Impact of the Central Blood Pressure Level in Cerebral Metabolic Aging: a 18F-FDG PET Study.
Actual Study Start Date :
Jul 31, 2018
Actual Primary Completion Date :
Nov 6, 2020
Actual Study Completion Date :
Nov 6, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Subjects

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.

Device: PET with a cerebral step
Positron Emission Tomography with a cerebral step before to carry out the standard Position Emission Tomography

Device: Central blood pressure measurement
Central blood pressure measurement

Other: Neurocognitive tests
Mini Mental State Examination, MMSE, Mini International Neuropsychiatric Interview MINI and Frontal Assessment Batery FAB

Outcome Measures

Primary Outcome Measures

  1. volume of brain areas detected by quantitative analysis [At inclusion]

  2. topography of brain areas detected by quantitative analysis [At inclusion]

  3. central blood pressure [At inclusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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) <15.

  • 18F-FDG PET examination showing ischemic, neurodegenerative, neoplastic or other brain lesions (independent of a normal or accelerated aging process).

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHRU Nancy Vandoeuvre les Nancy France 54511

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Antoine Verger, MD, PhD, CHRU Nancy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Antoine VERGER, MD, PhD, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT03345290
Other Study ID Numbers:
  • PSS2016/PACTEP-VERGER/VS
First Posted:
Nov 17, 2017
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Antoine VERGER, MD, PhD, Central Hospital, Nancy, France
Aging
Central pressure
FDG PET

Study Results

No Results Posted as of Aug 24, 2022