Comprehensive Imaging and Biomarker Assessment of Aortic Valve Stenosis

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-010239
    Sponsor Protocol Number: 16-010239

About this study

The purpose of this study is detection of relationship between biomarkers and the severity of AS (echocardiographic hemodynamics/CT-calcium load).  Detection of relationship between biomarkers to the consequences of AS on the LV (echo remodeling parameters and speckle-tracking LV strain).  Detection of differences on echocardiographic and CT-calcium load AS severity assessments between tricuspid and bicuspid valves.  Detection of biomarker associations with AS hemodynamics, CT-calcium load, LV remodeling and LV strain between tricuspid and bicuspid phenotypes. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Adult patients (≥18 years)
  • Tricuspid or bicuspid aortic valve (50% and 50%)
  • Normal echo-derived LVEF, > 50%
  • More than moderate echo-derived AS; peak velocity≥3 m/sec or MG≥20 mmHg
  • Able to understand and sign consent for non-contrast CT-imaging and blood draws as well as longitudinal follow-up

Exclusion Criteria

  • Any ongoing systemic cancer
  • Any ongoing autoimmune disease
  • Any ongoing or recent (within 2 weeks) inflammation, i.e., infection ,surgery, trauma
  • Current treatment with steroids or any immunosuppressant drug
  • Severe COPD
  • Severe liver disease
  • Any other valve disease ≥moderate
  • Women of child-bearing potential with a positive pregnancy test who would need to undergo research CT.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Hector Michelena, M.D.

Open for enrollment

Contact information:

Diana Albers

(507)255-6884

Albers.Diana2@mayo.edu