This trial is active, not recruiting.

Condition aortic stenosis
Sponsor University of Edinburgh
Collaborator NHS Lothian
Start date July 2010
End date July 2014
Trial size 168 participants
Trial identifier NCT01358513, RING OF FIRE


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Patients with normal aortic valves
To undergo PET imaging and follow up with CT and echo for 2 years
To undergo PET imaging and follow up with CT and echo for 2 years
To undergo PET imaging and follow up with CT and echo for 2 years
To undergo PET imaging and follow up with CT and echo for 2 years

Primary Outcomes

Aortic Valve Peak Velocity
time frame: 2 years

Eligibility Criteria

Male or female participants at least 50 years old.

Inclusion Criteria: - Age > 50 years Exclusion Criteria: - Age < 50 years - Life expectancy < 2 years - Insulin dependent diabetes mellitus - Connective Tissue disorders

Additional Information

Official title An Observational PET/CT Study Examining the Role of Active Valvular Calcification and Inflammation in Patients With Aortic Stenosis
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by University of Edinburgh.