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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by University of Edinburgh.
Recruitment status was:  Active, not recruiting
NHS Lothian
British Heart Foundation
Information provided by (Responsible Party):
University of Edinburgh Identifier:
First received: May 19, 2011
Last updated: January 9, 2015
Last verified: January 2015
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

Aortic Stenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational PET/CT Study Examining the Role of Active Valvular Calcification and Inflammation in Patients With Aortic Stenosis

Resource links provided by NLM:

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Aortic Valve Peak Velocity [ Time Frame: 2 years ]
    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

Biospecimen Retention:   Samples With DNA
In patients undergoing aortic valve replacement during the course of the trial we will retain samples of their aortic valve for histological studies.

Estimated Enrollment: 168
Study Start Date: July 2010
Estimated Study Completion Date: July 2015
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Control Patients
Patients with normal aortic valves
Aortic sclerosis
To undergo PET imaging and follow up with CT and echo for 2 years
Mild Aortic stenosis
To undergo PET imaging and follow up with CT and echo for 2 years
Moderate Aortic stenosis
To undergo PET imaging and follow up with CT and echo for 2 years
Severe aortic stenosis
To undergo PET imaging and follow up with CT and echo for 2 years

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.

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The investigators will recruit 168 patients: 24 control patients, 24 mild, 48 moderate and 48 severe aortic stenosis

Inclusion Criteria:

  • Age > 50 years

Exclusion Criteria:

  • Age < 50 years
  • Life expectancy < 2 years
  • Insulin dependent diabetes mellitus
  • Connective Tissue disorders
  Contacts and Locations
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Please refer to this study by its identifier: NCT01358513

United Kingdom
Centre for Cardiovascular Sciences, University of Edinburgh
Edinburgh, Scotland, United Kingdom, EH16 4SE
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
British Heart Foundation
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Edinburgh Identifier: NCT01358513     History of Changes
Other Study ID Numbers: RING OF FIRE
Study First Received: May 19, 2011
Last Updated: January 9, 2015

Keywords provided by University of Edinburgh:
Positron Emission Tomography

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathologic Processes
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Calcium Metabolism Disorders
Metabolic Diseases processed this record on May 25, 2017