Brief Title
Role of Active Valvular Calcification and Inflammation in Patients With Aortic Stenosis
Official Title
An Observational PET/CT Study Examining the Role of Active Valvular Calcification and Inflammation in Patients With Aortic Stenosis
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.
Study Type
Observational
Primary Outcome
Aortic Valve Peak Velocity
Condition
Aortic Stenosis
Study Arms / Comparison Groups
Control Patients
Description: Patients with normal aortic valves
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
121
Start Date
July 2010
Completion Date
July 2015
Primary Completion Date
July 2014
Eligibility Criteria
Inclusion Criteria: - Age > 50 years Exclusion Criteria: - Age < 50 years - Life expectancy < 2 years - Insulin dependent diabetes mellitus - Connective Tissue disorders
Gender
All
Ages
50 Years - 100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT01358513
Organization ID
RING OF FIRE
Responsible Party
Sponsor
Study Sponsor
University of Edinburgh
Collaborators
NHS Lothian
Study Sponsor
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Verification Date
January 2015