Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis
Condition: Aortic Valve Stenosis; Myocardial Fibrosis
MeSH terms: Aortic Valve Stenosis; Fibrosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      This study is part of a research project in which new ultrasound-based techniques will be
      examined to improve clinical decision making for patients with aortic stenosis. These
      patients could develop increased amounts of myocardial fibrosis. This fibrosis is associated
      with the patients' prognosis. Fibrosis can be evaluated with magnetic resonance imaging
      (MRI), which unfortunately is quite expensive and not easily available. Ultrasound-based
      parameters will be developed for the assessment of the amounts of myocardial fibrosis,
      especially in the left ventricle. Then it will be examined whether these parameters can
      predict the patients magnitude of fibrosis and check for association with the patients
      prognosis. MRI will serve as a gold standard for quantification of myocardial fibrosis. The
      new echocardiographic techniques and parameters are expected to provide new insights in the
      interplay between aortic stenosis and left ventricular function, and to ultimately improve
      the care for patients with aortic stenosis.

      The present study's objectives are:

        -  Quantify the level of myocardial fibrosis in mild, moderate, and severe aortic stenosis
           compared with a healthy population.

        -  Evaluate the patients outcome after one and three year of follow-up
    


Intervention name(s): Echocardiography; MRI; Blood test; ECG and Holter-ECG; 6 min walking test
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Conventional transthoracic echocardiography will be performed, in addition 3D-imaging and acquisitions with high frame rate. The data from these patients will be anonymized and transferred for post-hoc analysis in dedicated computer software (GE Vingmed, EchoPac 2.0) and in validated machine learning algorithms.; Cardiac MRI will be performed. In all patients without contraindications a gadolinium-based contrast agent will be given.; Conventional brachial venous blood samples will be drawn. Blood samples will be analyzed for markers of myocardial fibrosis at Oslo University Hospital.The findings will be related to imaging findings.; ECG/Holter-ECG will be performed, and the findings will be related to the imaging findings.; 6 MWT will be performed, and the findings will be related to findings from MRI/echocardiography.
Other intervention name(s): GE Vingmed ultrasound scanner e95, 2017; Magnetic resonance imaging
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: All participants will undergo 'echo', bloodtests and MRI. Participating patients will in addition undergo electrocardiogram (ECG/Holter ECG) and 6 min walking test.
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Myocardium; Predictive Value of Tests; Prognosis; Clinical Decision-making; Heart Ventricles; Echocardiography