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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of Edinburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
NHS Lothian
British Heart Foundation
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01358513
First received: May 19, 2011
Last updated: May 20, 2011
Last verified: May 2011

May 19, 2011
May 20, 2011
July 2010
July 2013   (final data collection date for primary outcome measure)
Aortic Valve Peak Velocity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01358513 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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

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 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

In patients undergoing aortic valve replacement during the course of the trial we will retain samples of their aortic valve for histological studies.

Non-Probability Sample

The investigators will recruit 168 patients: 24 control patients, 24 mild, 48 moderate and 48 severe aortic stenosis

Aortic Stenosis
Not Provided
  • Control Patients
    Patients with normal aortic valves
  • Aortic sclerosis
  • Mild Aortic stenosis
  • Moderate Aortic stenosis
  • Severe aortic stenosis

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
168
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 50 years

Exclusion Criteria:

  • Age < 50 years
  • Life expectancy < 2 years
  • Insulin dependent diabetes mellitus
  • Connective Tissue disorders
Both
50 Years and older
Yes
Contact: Marc Dweck, MBChB BSc 0131 242 6422 marcdweck@hotmail.com
Contact: David Newby, MBChB PhD 0131 242 6422 D.E.NEWBY@ED.AC.UK
United Kingdom
 
NCT01358513
RING OF FIRE
Yes
Gemma Watson, University of Edinburgh
University of Edinburgh
  • NHS Lothian
  • British Heart Foundation
Not Provided
University of Edinburgh
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP