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

Aortic Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358513
• Other study ID #: RING OF FIRE
• Status: Completed
• Start date: July 2010
• Est. completion date: July 2015

Study information

• Verified date: January 2015
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: July 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age > 50 years

Exclusion Criteria:

• Age < 50 years

• Life expectancy < 2 years

• Insulin dependent diabetes mellitus

• Connective Tissue disorders

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Calcinosis
• Constriction, Pathologic
• Inflammation

Locations

Country	Name	City	State
United Kingdom	Centre for Cardiovascular Sciences, University of Edinburgh	Edinburgh	Scotland

Sponsors (3)

Lead Sponsor	Collaborator
University of Edinburgh	British Heart Foundation, NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aortic Valve Peak Velocity	We 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	2 years