A Comparison of Advanced Imaging Techniques in Aortic Stenosis (AIm-AS)

November 27, 2014 updated by: Royal Brompton & Harefield NHS Foundation Trust

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Tertiary care Outpatient population under regular follow by either cardiology or cardio thoracic team.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A - Symptomatic severe AS
Patients with symptomatic severe aortic stenosis (AS) as per ESC guidelines, requiring aortic valve replacement.
Other: Cardiac MRI
Radiation: Cardiac I123-MIBG Scintigraphy
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.
Other: Cardiac MRI
Radiation: Cardiac I123-MIBG Scintigraphy
Other: Stress and rest Echocardiogram
Other: High Sensitivity Troponin I
Other: Brain Natriuretic Peptide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Need for aortic valve replacement
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in measured indices post aortic valve replacement
Time Frame: 6 months
6 months

Other Outcome Measures

Outcome Measure
Time Frame
The change in rate of measured indices over time
Time Frame: 6 months - 1 year
6 months - 1 year
The relative change in measured indices between each other over time
Time Frame: 6 months - 1 year
6 months - 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Investigators

  • Principal Investigator: Andrew Kelion, MRCP DM, Royal Brompton and Harefield NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

January 22, 2013

First Posted (Estimate)

January 24, 2013

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

November 27, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/LO/1846

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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