A Comparison of Advanced Imaging Techniques in Aortic Stenosis
NCT ID: NCT01775215
Last Updated: 2014-12-02
Study Results
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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WITHDRAWN
OBSERVATIONAL
2013-01-31
2016-01-31
Brief Summary
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We aim to compare all validated techniques looking at different aspects of heart muscle strain in these patients. These will be a blood sample measuring a specific hormone (BNP) and enzyme (Troponin), a nuclear scan to assess nerve activation, an MRI identifying scarring and an exercise echocardiogram that measures heart muscle response and pressure changes across the valve. Tests will be performed at recruitment and either after one year or after valve replacement, which ever comes first.
In comparing these different imaging techniques we aim to identify patients who will benefit from an early operation, those whose muscle is likely to recover back to normal and which patients it is safe to wait longer for the surgery, avoiding unnecessary risk.
The results of the study will benefit patients as it will help doctors more accurately assess the timing of valve surgery and improve their prediction of long term heart muscle recovery. It may also increase convenience in clinical management by reducing unnecessary tests and hospital trips. This would translate into cost savings for the NHS.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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A - Symptomatic severe AS
Patients with symptomatic severe aortic stenosis (AS) as per ESC guidelines, requiring aortic valve replacement.
Cardiac I123-MIBG Scintigraphy
Cardiac MRI
Stress and rest Echocardiogram
High Sensitivity Troponin I
Brain Natriuretic Peptide
B - Asymptomatic moderate to severe AS
Asymptomatic patients with moderate to severe aortic stenosis (AS) as per ESC guidelines ,with Left Ventricular ejection fraction \>50%, not yet requiring aortic valve replacement.
Cardiac I123-MIBG Scintigraphy
Cardiac MRI
Stress and rest Echocardiogram
High Sensitivity Troponin I
Brain Natriuretic Peptide
Interventions
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Cardiac I123-MIBG Scintigraphy
Cardiac MRI
Stress and rest Echocardiogram
High Sensitivity Troponin I
Brain Natriuretic Peptide
Eligibility Criteria
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Inclusion Criteria
* Asymptomatic patients with moderate to severe Aortic Stenosis
* Ejection fraction greater than 50%
* Not yet being considered for valve surgery
(Group B)
* Severe Aortic Stenosis (as per ESC guidelines)
* Listed for immediate aortic valve replacement
Exclusion Criteria
* Concurrent primary valve lesions greater than mild (as defined by ESC criteria)
* Previous myocardial infarction (regional wall motion abnormality on resting echo)
* Cardiomyopathy
* Congenital heart disease
* Previous cardiac surgery
* Renal failure (CKD stage 3, eGFR \>30ml/min/1.73m2)
* Pregnancy, risk of pregnancy, breast feeding
18 Years
ALL
No
Sponsors
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Royal Brompton & Harefield NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Andrew Kelion, MRCP DM
Role: PRINCIPAL_INVESTIGATOR
Royal Brompton and Harefield NHS Foundation Trust
Locations
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Harefield Hospital
London, , United Kingdom
Countries
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Other Identifiers
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12/LO/1846
Identifier Type: -
Identifier Source: org_study_id