A Comparison of Advanced Imaging Techniques in Aortic Stenosis (AIm-AS)
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Purpose
In patients with aortic stenosis the valve through which blood is pumped out of the main heart chamber is narrowed. This results in heart muscle working harder to open the valve so blood can circulate around the body. The muscle adapts to the increased pressure load to maintain efficiency. This can cause long-term muscle damage. To predict when this deterioration will require a valve replacement is difficult and untimely operation exposes patients to unnecessary risk.
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.
| Condition | Intervention |
|---|---|
|
Aortic Stenosis |
Radiation: Cardiac I123-MIBG Scintigraphy Other: Cardiac MRI Other: Stress and rest Echocardiogram Other: High Sensitivity Troponin I Other: Brain Natriuretic Peptide |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Comparative Study of Advanced Imaging Techniques in Predicting the Clinical Outcome in Aortic Stenosis |
- Need for aortic valve replacement [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Improvement in measured indices post aortic valve replacement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- The change in rate of measured indices over time [ Time Frame: 6 months - 1 year ] [ Designated as safety issue: No ]
- The relative change in measured indices between each other over time [ Time Frame: 6 months - 1 year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Blood serum sample.
| Estimated Enrollment: | 105 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
A - Symptomatic severe AS
Patients with symptomatic severe aortic stenosis (AS) as per ESC guidelines, requiring aortic valve replacement.
|
Radiation: Cardiac I123-MIBG Scintigraphy Other: Cardiac MRI Other: Stress and rest Echocardiogram Other: High Sensitivity Troponin I Other: 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.
|
Radiation: Cardiac I123-MIBG Scintigraphy Other: Cardiac MRI Other: Stress and rest Echocardiogram Other: High Sensitivity Troponin I Other: Brain Natriuretic Peptide |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Tertiary care Outpatient population under regular follow by either cardiology or cardio thoracic team.
Inclusion Criteria:
(Group A)
- 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: (Group A and B)
- Inability to provide informed consent
- 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
Contacts and Locations| United Kingdom | |
| Harefield Hospital | |
| London, United Kingdom, UB9 6JH | |
| Principal Investigator: | Andrew Kelion, MRCP DM | Royal Brompton and Harefield NHS Foundation Trust |
More Information
No publications provided
| Responsible Party: | Royal Brompton & Harefield NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01775215 History of Changes |
| Other Study ID Numbers: | 12/LO/1846 |
| Study First Received: | January 22, 2013 |
| Last Updated: | January 22, 2013 |
| Health Authority: | United Kingdom: National Health Service United Kingdom: Research Ethics Committee |
Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
|
Left Ventricular Function Aortic Valve Replacement Late Gadolinium Enhancement Cardiac I123 MIBG |
Longitudinal Strain Brain Natriuretic Peptide High Sensitivity Troponin I |
Additional relevant MeSH terms:
|
Aortic Valve Stenosis Constriction, Pathologic Heart Valve Diseases Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction Pathological Conditions, Anatomical |
Natriuretic Peptide, Brain Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013