Role of Active Valvular Calcification and Inflammation in Patients With Aortic Stenosis
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Purpose
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
| Condition |
|---|
|
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 |
- 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
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 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Control Patients
Patients with normal aortic valves
|
| Aortic sclerosis |
| Mild Aortic stenosis |
| Moderate Aortic stenosis |
| Severe aortic stenosis |
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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| 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 | |
| Centre for Cardiovascular Sciences, University of Edinburgh | Recruiting |
| Edinburgh, Scotland, United Kingdom, EH16 4SE | |
| Contact: Marc Dweck, MBChB BSc 0131 242 6422 marcdweck@hotmail.com | |
| Principal Investigator: David Newby, MBChB PhD | |
| Sub-Investigator: Marc Dweck, MBChB BSc | |
More Information
No publications provided by University of Edinburgh
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gemma Watson, University of Edinburgh |
| ClinicalTrials.gov Identifier: | NCT01358513 History of Changes |
| Other Study ID Numbers: | RING OF FIRE |
| Study First Received: | May 19, 2011 |
| Last Updated: | May 20, 2011 |
| Health Authority: | United Kingdom: Research Ethics Committee United Kingdom: National Health Service |
Keywords provided by University of Edinburgh:
|
Positron Emission Tomography Inflammation Calcification |
Additional relevant MeSH terms:
|
Aortic Valve Stenosis Calcinosis Constriction, Pathologic Inflammation Heart Valve Diseases Heart Diseases |
Cardiovascular Diseases Ventricular Outflow Obstruction Calcium Metabolism Disorders Metabolic Diseases Pathological Conditions, Anatomical Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013