Aortic StenosisAIm-ASNCT01775215
A Comparison of Advanced Imaging Techniques in Aortic Stenosis
An observational study of Aortic Stenosis, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Cardiac I123-MIBG Scintigraphy, Cardiac MRI and Stress and rest Echocardiogram
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tertiary care Outpatient population under regular follow by either cardiology or cardio thoracic team.
Who may be able to join
- (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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Aortic Stenosis
- Being tested
- Cardiac I123-MIBG Scintigraphy, Cardiac MRI, Stress and rest Echocardiogram, High Sensitivity Troponin I, Brain Natriuretic Peptide
- Keywords
- Left Ventricular Function, Aortic Valve Replacement, Late Gadolinium Enhancement, Cardiac I123 MIBG, Longitudinal Strain, Brain Natriuretic Peptide, High Sensitivity Troponin I
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac I123-MIBG ScintigraphyRadiation
Cardiac MRIOther
Stress and rest EchocardiogramOther
High Sensitivity Troponin IOther
Brain Natriuretic PeptideOther
| Study group | Role | What they receive |
|---|---|---|
| A - Symptomatic severe AS | Patients with symptomatic severe aortic stenosis (AS) as per ESC guidelines, requiring aortic valve replacement. Receives: 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. Receives: Radiation: Cardiac I123-MIBG Scintigraphy; Other: Cardiac MRI; Other: Stress and rest Echocardiogram; Other: High Sensitivity Troponin I; Other: Brain Natriuretic Peptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for aortic valve replacement
Measured: 1 year
Secondary outcomes (1)
Improvement in measured indices post aortic valve replacement
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2015 (estimated)
- Study completionJan 2016 (estimated)
Why it stopped: Abandoned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Kelion, MRCP DM, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775215
- Sponsor's protocol ID
- 12/LO/1846
- Acronym
- AIm-AS
- Status last verified
- Nov 2014
- First submitted
- 22 Jan 2013
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Advanced Imaging Techniques in Predicting the Clinical Outcome in Aortic Stenosis
- ClinicalTrials.gov ID
- NCT01775215
- Acronym / sponsor ID
- AIm-AS / 12/LO/1846
- 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
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Abandoned
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - Symptomatic severe AS | – | Radiation: Cardiac I123-MIBG Scintigraphy, Other: Cardiac MRI, Other: Stress and rest Echocardiogram, Other: High Sensitivity Troponin I, Other: Brain Natriuretic PeptidePatients with symptomatic severe aortic stenosis (AS) as per ESC guidelines, requiring aortic valve replacement. |
| B - Asymptomatic moderate to severe AS | – | Radiation: Cardiac I123-MIBG Scintigraphy, Other: Cardiac MRI, Other: Stress and rest Echocardiogram, Other: High Sensitivity Troponin I, Other: Brain Natriuretic PeptideAsymptomatic patients with moderate to severe aortic stenosis (AS) as per ESC guidelines ,with Left Ventricular ejection fraction >50%, not yet requiring aortic valve replacement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary care Outpatient population under regular follow by either cardiology or cardio thoracic team.
Key inclusion criteria (7 listed)
- (Group A)
- Asymptomatic patients with moderate to severe Aortic Stenosis
- Ejection fraction greater than 50%
- Not yet being considered for valve surgery
- (Group B)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac I123-MIBG Scintigraphy | Radiation | A - Symptomatic severe AS, B - Asymptomatic moderate to severe AS |
| Cardiac MRI | Other | A - Symptomatic severe AS, B - Asymptomatic moderate to severe AS |
| Stress and rest Echocardiogram | Other | A - Symptomatic severe AS, B - Asymptomatic moderate to severe AS |
| High Sensitivity Troponin I | Other | A - Symptomatic severe AS, B - Asymptomatic moderate to severe AS |
| Brain Natriuretic Peptide | Other | A - Symptomatic severe AS, B - Asymptomatic moderate to severe AS |
Primary outcome
Need for aortic valve replacement
Time frame: 1 year
1 secondary outcome
Improvement in measured indices post aortic valve replacement
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Kelion, MRCP DM principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for aortic valve replacement (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.