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Role of Active Valvular Calcification and Inflammation in Patients With Aortic Stenosis

An Observational PET/CT Study Examining the Role of Active Valvular Calcification and Inflammation in Patients With Aortic Stenosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01358513
Enrollment
121
Registered
2011-05-23
Start date
2010-07-31
Completion date
2015-07-31
Last updated
2018-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis

Keywords

Positron Emission Tomography, Inflammation, Calcification

Brief summary

The aortic valve is the main outlet valve from the heart. This valve can become diseased and narrowed when it needs to be replaced with an artificial valve. Currently, this is the commonest reason for someone to undergo a heart valve operation in the UK. Unfortunately, there are no medical treatments that can prevent or delay the progression of this disease process. Here, the investigators propose to use new state-of-the-art imaging techniques to better understand the disease process so that the investigators can effectively design and assess potential new treatments. The ultimate aim is to stop this disease before patients need to have surgery. In addition the investigators believe this technique will allow us to predict the rate of progression of the disease

Detailed description

Aortic stenosis is the commonest valvular heart disease in the western world and is the leading indication for valve surgery. Histological studies have suggested similarities with atherosclerosis including inflammation, lipid deposition, increased macrophage activity and calcification. However, recent randomised controlled trials have failed to demonstrate a reduction in the rate of disease progression with statin therapy and the investigators believe there is now a need to re-evaluate the underlying factors involved in the initiation and progression of aortic stenosis. The investigators propose to assess the role of inflammation and calcification in the pathogenesis and progression of aortic stenosis by using positron emission tomography with \[18F\]-fluorodeoxyglucose and \[18F-\]-fluoride in patients with a range of aortic valve disease. The investigators hypothesise that increasing severity of valvular inflammation and calcification will correlate with disease severity and rate of disease progression. This work will lay the foundation for the subsequent application of interventions targeted at inflammation and calcification.

Interventions

None listed

Sponsors

NHS Lothian
CollaboratorOTHER_GOV
British Heart Foundation
CollaboratorOTHER
University of Edinburgh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* Age \> 50 years

Exclusion criteria

* Age \< 50 years * Life expectancy \< 2 years * Insulin dependent diabetes mellitus * Connective Tissue disorders

Design outcomes

Primary

MeasureTime frameDescription
Aortic Valve Peak Velocity2 yearsWe beleive NaF and FDG uptake in the valve will predict rate of progression of the disease. Disease severity will be measured by the aortic valve peak velocity

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026