Evaluation of Splenic Metabolic Activity With 18FDG-PET in Hypertension
1 other identifier
observational
120
1 country
1
Brief Summary
The purpose of this study is to evaluate the splenic activation in hypertensive patients, as compared to normotensives, using FDG-PET/CT imaging. Moreover, the investigators will investigate whether the splenic metabolic activity relates to the expression of circulating inflammatory proteins (high-sensitivity C-reactive protein \[hsCRP\]), interleukin-1b (IL-1b), tumor necrosis factor-a (TNF-a) or to immune profiles of activated T cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2018
Longer than P75 for all trials
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
October 7, 2015
CompletedFirst Posted
Study publicly available on registry
October 9, 2015
CompletedStudy Start
First participant enrolled
January 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedApril 11, 2022
April 1, 2022
4.9 years
October 7, 2015
April 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Splenic metabolic activity
18FDG uptake in splenic tissue
At enrollment
Secondary Outcomes (1)
Circulating pro-inflammatory markers
At enrollment
Study Arms (2)
Normotensive
Normotensive subjects
Hypertensive
Hypertensive subjects
Interventions
Eligibility Criteria
Subjects will be selected from patients who will undergo FDG-PET/CT imaging of chest and abdomen in the Department of Nuclear Medicine of IRCCS Neuromed, accordingly to the following inclusion/exclusion criteria. All the enrolled patients must have an indication for FDG-PET/CT. Approximately 120 hypertensive and normotensive subjects of both genders (at least 45 per group, in order to have the appropriate statistical power) will be included in the study.
You may qualify if:
- absence of prior cancer diagnosis or remission from cancer at the time of FDG-PET/CT imaging (from at least 6 months)
- age ≥ 30 and ≤ 85 years
- absence of acute cardio/cerebrovascular disease (myocardial infarction, stroke, transient ischemic attack, revascularization)
- absence of acute or chronic inflammatory or autoimmune disease
- diagnosis of presence/absence of hypertension, on the basis of documented medical history
You may not qualify if:
- diabetes
- atrial fibrillation
- use of anti-inflammatory drugs in the week preceding the FDG-PET/CT imaging
- chronic use of anti-inflammatory drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuromed IRCCSlead
Study Sites (1)
IRCCS Neuromed
Pozzilli, (IS), 86077, Italy
Biospecimen
Total blood and serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- prof. Giuseppe Lembo
Study Record Dates
First Submitted
October 7, 2015
First Posted
October 9, 2015
Study Start
January 2, 2018
Primary Completion
December 1, 2022
Study Completion
September 1, 2023
Last Updated
April 11, 2022
Record last verified: 2022-04