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

NCT ID: NCT01358513

Last Updated: 2018-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2015-07-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Aortic Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control Patients

Patients with normal aortic valves

No interventions assigned to this group

Aortic sclerosis

To undergo PET imaging and follow up with CT and echo for 2 years

No interventions assigned to this group

Mild Aortic stenosis

To undergo PET imaging and follow up with CT and echo for 2 years

No interventions assigned to this group

Moderate Aortic stenosis

To undergo PET imaging and follow up with CT and echo for 2 years

No interventions assigned to this group

Severe aortic stenosis

To undergo PET imaging and follow up with CT and echo for 2 years

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age \> 50 years

Exclusion Criteria

* Age \< 50 years
* Life expectancy \< 2 years
* Insulin dependent diabetes mellitus
* Connective Tissue disorders
Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NHS Lothian

OTHER_GOV

Sponsor Role collaborator

British Heart Foundation

OTHER

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre for Cardiovascular Sciences, University of Edinburgh

Edinburgh, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

References

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Fletcher AJ, Tew YY, Tzolos E, Joshi SS, Kaczynski J, Nash J, Debono S, Lembo M, Kwiecinski J, Bing R, Syed MBJ, Doris MK, van Beek EJR, Moss AJ, Jenkins WS, Walker NL, Joshi NV, Pawade TA, Adamson PD, Whiteley WN, Wardlaw JM, Slomka PJ, Williams MC, Newby DE, Dweck MR. Thoracic Aortic 18F-Sodium Fluoride Activity and Ischemic Stroke in Patients With Established Cardiovascular Disease. JACC Cardiovasc Imaging. 2022 Jul;15(7):1274-1288. doi: 10.1016/j.jcmg.2021.12.013. Epub 2022 Feb 16.

Reference Type DERIVED
PMID: 35183477 (View on PubMed)

Pawade T, Clavel MA, Tribouilloy C, Dreyfus J, Mathieu T, Tastet L, Renard C, Gun M, Jenkins WSA, Macron L, Sechrist JW, Lacomis JM, Nguyen V, Galian Gay L, Cuellar Calabria H, Ntalas I, Cartlidge TRG, Prendergast B, Rajani R, Evangelista A, Cavalcante JL, Newby DE, Pibarot P, Messika Zeitoun D, Dweck MR. Computed Tomography Aortic Valve Calcium Scoring in Patients With Aortic Stenosis. Circ Cardiovasc Imaging. 2018 Mar;11(3):e007146. doi: 10.1161/CIRCIMAGING.117.007146.

Reference Type DERIVED
PMID: 29555836 (View on PubMed)

Dweck MR, Jenkins WS, Vesey AT, Pringle MA, Chin CW, Malley TS, Cowie WJ, Tsampasian V, Richardson H, Fletcher A, Wallace WA, Pessotto R, van Beek EJ, Boon NA, Rudd JH, Newby DE. 18F-sodium fluoride uptake is a marker of active calcification and disease progression in patients with aortic stenosis. Circ Cardiovasc Imaging. 2014 Mar;7(2):371-8. doi: 10.1161/CIRCIMAGING.113.001508. Epub 2014 Feb 7.

Reference Type DERIVED
PMID: 24508669 (View on PubMed)

Dweck MR, Khaw HJ, Sng GK, Luo EL, Baird A, Williams MC, Makiello P, Mirsadraee S, Joshi NV, van Beek EJ, Boon NA, Rudd JH, Newby DE. Aortic stenosis, atherosclerosis, and skeletal bone: is there a common link with calcification and inflammation? Eur Heart J. 2013 Jun;34(21):1567-74. doi: 10.1093/eurheartj/eht034. Epub 2013 Feb 7.

Reference Type DERIVED
PMID: 23391586 (View on PubMed)

Dweck MR, Chow MW, Joshi NV, Williams MC, Jones C, Fletcher AM, Richardson H, White A, McKillop G, van Beek EJ, Boon NA, Rudd JH, Newby DE. Coronary arterial 18F-sodium fluoride uptake: a novel marker of plaque biology. J Am Coll Cardiol. 2012 Apr 24;59(17):1539-48. doi: 10.1016/j.jacc.2011.12.037.

Reference Type DERIVED
PMID: 22516444 (View on PubMed)

Dweck MR, Jones C, Joshi NV, Fletcher AM, Richardson H, White A, Marsden M, Pessotto R, Clark JC, Wallace WA, Salter DM, McKillop G, van Beek EJ, Boon NA, Rudd JH, Newby DE. Assessment of valvular calcification and inflammation by positron emission tomography in patients with aortic stenosis. Circulation. 2012 Jan 3;125(1):76-86. doi: 10.1161/CIRCULATIONAHA.111.051052. Epub 2011 Nov 16.

Reference Type DERIVED
PMID: 22090163 (View on PubMed)

Other Identifiers

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RING OF FIRE

Identifier Type: -

Identifier Source: org_study_id

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