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NCT02572765 Clinical Trial

Evaluation of Splenic Metabolic Activity With 18FDG-PET in Hypertension

Hypertension Clinical Trial

Official title:
Evaluation of Splenic Metabolic Activity With 18FDG-PET in Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02572765
Other study ID # LMB05
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2, 2018
Est. completion date September 2023

Study information
Verified date April 2022
Source Neuromed IRCCS
Contact Giuseppe Lembo, MD in Cardiology
Phone +39 0865.915225
Email lembo@neuromed.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date September 2023
Est. primary completion date December 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 85 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - diabetes - atrial fibrillation - use of anti-inflammatory drugs in the week preceding the FDG-PET/CT imaging - chronic use of anti-inflammatory drugs

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• PET/CT scan
PET/CT scan

Locations
Country Name City State
Italy IRCCS Neuromed Pozzilli (is)

Sponsors (1)
Lead Sponsor Collaborator
Neuromed IRCCS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Splenic metabolic activity 18FDG uptake in splenic tissue At enrollment
Secondary Circulating pro-inflammatory markers Serum levels of pro-inflammatory cytokines At enrollment
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