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A Comparison of Advanced Imaging Techniques in Aortic Stenosis

A Comparative Study of Advanced Imaging Techniques in Predicting the Clinical Outcome in Aortic Stenosis

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01775215
Acronym
AIm-AS
Enrollment
0
Registered
2013-01-24
Start date
2013-01-31
Completion date
2016-01-31
Last updated
2014-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis

Keywords

Left Ventricular Function, Aortic Valve Replacement, Late Gadolinium Enhancement, Cardiac I123 MIBG, Longitudinal Strain, Brain Natriuretic Peptide, High Sensitivity Troponin I

Brief summary

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.

Interventions

RADIATIONCardiac I123-MIBG Scintigraphy
OTHERCardiac MRI
OTHERStress and rest Echocardiogram

Sponsors

Royal Brompton & Harefield NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Need for aortic valve replacement1 year

Secondary

MeasureTime frame
Improvement in measured indices post aortic valve replacement6 months

Other

MeasureTime frame
The change in rate of measured indices over time6 months - 1 year
The relative change in measured indices between each other over time6 months - 1 year

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026