A Comparison of Advanced Imaging Techniques in Aortic Stenosis

Aortic Stenosis Clinical Trial

— AIm-AS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01775215
• Other study ID #: 12/LO/1846
• Status: Withdrawn
• Phase: N/A
• First received: January 22, 2013
• Last updated: November 27, 2014
• Start date: January 2013
• Est. completion date: January 2016

Study information

• Verified date: November 2014
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Radiation:
• Cardiac I123-MIBG Scintigraphy

Other:
• Cardiac MRI

• Stress and rest Echocardiogram

• High Sensitivity Troponin I

• Brain Natriuretic Peptide

Locations

Country	Name	City	State
United Kingdom	Harefield Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The change in rate of measured indices over time		6 months - 1 year	No
Other	The relative change in measured indices between each other over time		6 months - 1 year	No
Primary	Need for aortic valve replacement		1 year	No
Secondary	Improvement in measured indices post aortic valve replacement		6 months	No