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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01775215
First received: January 22, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:
  • Need for aortic valve replacement [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in measured indices post aortic valve replacement [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775215

Locations
United Kingdom
Harefield Hospital
London, United Kingdom, UB9 6JH
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
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 July 24, 2014