Status:

COMPLETED

Positron Emission Tomography / Magnetic Resonance Imaging in Aortic Stenosis

Lead Sponsor:

University of Edinburgh

Conditions:

Aortic Stenosis

Transthyretin Amyloidosis

Eligibility:

All Genders

70+ years

Brief Summary

Aortic stenosis is the most common valve disease requiring surgery in the Western world. It is defined by progressive calcification and fibrosis of the valve leaflets and restricted valve opening. Thi...

Eligibility Criteria

Inclusion

  • Inclusion Criteria (AS group)
  • Severe aortic stenosis
  • Referred for aortic valve intervention (surgical AVR / TAVI)
  • High clinical suspicion of amyloid (e.g. low-flow low-gradient AS, inappropriate LVH)
  • Age \>70 years
  • Willing and able to comply with study protocol
  • Exclusion Criteria (AS group)
  • Inability to give informed consent
  • Contraindication to MRI scanning (e.g. permanent pacemaker)
  • Significant renal impairment (eGFR \<30 ml/min/1.73 m2)
  • Coexistent moderate or severe aortic regurgitation or mitral stenosis
  • Acute valvular heart disease (e.g. acute mitral regurgitation or endocarditis)
  • Acute pulmonary oedema or cardiogenic shock
  • Inclusion Criteria (Healthy volunteers)
  • No symptoms suggesting current cardiovascular disease
  • Age \>70
  • Willing and able to comply with study protocol
  • Exclusion Criteria (Healthy volunteers)
  • Inability to give informed consent
  • Contraindication to MRI scanning (e.g. permanent pacemaker)
  • Significant renal impairment (eGFR \<30 ml/min/1.73 m2)
  • Known significant valvular heart disease (more than mild regurgitant valve lesion or any stenotic lesion)

Exclusion

    Key Trial Info

    Start Date :

    November 1 2017

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    August 23 2018

    Estimated Enrollment :

    22 Patients enrolled

    Trial Details

    Trial ID

    NCT03352089

    Start Date

    November 1 2017

    End Date

    August 23 2018

    Last Update

    June 11 2024

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    University of Edinburgh / NHS Lothian

    Edinburgh, Midlothian, United Kingdom, EH164SB