St. Olavs Hosptial
Trondheim, Trøndelag, 7030, Norway
NCT Number: NCT06571175
This study is a long term follow-up of patients that were included as part of a previous study (NCT03422770), where patients with aortic stenosis and healthy controls went through echocardiography, cardiac MRI, long-term ECG-recording, blood tests and quality of life assessment. Echocardiography included high frame ultrasound for detection of natural mechanical waves, and the measured speed of these waves were used as a marker of the extent of myocardial fibrosis.
Up to five years have now passed since inclusion at baseline, and a proportion of the patients in the cohort have undergone aortic valve replacement at some point. In this study, the investigators will repeat the cardiac imaging (echocardiography and cardiac MRI), ECG and blood test, to assess long-term changes in myocardial fibrosis in aortic stenosis patients.
Interested in participating?
Request Info18 year–90 year
All sexes
Observational
Trondheim, Trøndelag, 7030, Norway
High frame rate ultrasound with quantification of myocardial mechanical wave velocities provides a new approach to evaluation of myocardial stiffness.
Principle: An elastic medium (the left ventricle) is incited by a force (naturally occuring mechanical wave generated by atrial contraction and/or closure of mitral and aortic valve), and the resulting oscillation wave propagates through the medium with a speed that depends only on the density and stiffness of the medium. If the density of the medium is known, measuring the propagation velocity of the wave is the same as measuring the stiffness of the medium.
There is a lack of longitudinal data in this research area. A follow-up study of the described cohort, will add valuable insight into high frame rate ultrasound as a potential tool to quantify myocardial fibrosis in heart failure patient, and to monitor any changes from baseline.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Conventional transthoracic echocardiography will be performed, with added 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 2.6) and in validated machine learning algorithms.
Other names: GE Vingmed ultrasound scanner E95, 2017
Cardiac MRI will be performed. In all patients without contraindications, a gadolinium-based contrast agent will be given.
Other names: Cardiac magnetic resonance imaging (CMRI)
Conventional brachial venous blood samples will be drawn. Hematocrit value {in %} will be used to calculate CMR-derived exttracellular volume (ECV)
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 CMRI/echocardiography.
Time frame: 5 year
Admissions with heart failure
Time frame: 5 year
Death caused by cardiac disease
Time frame: 5 years
Mortality in general
Time frame: 5 years
Time of first re-hospitalization after inclusion
Time frame: 5 years
Systolic function based on left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS).
Unit of measure for LVEF and for GLS is % for both (a positive number for LVEF, and a negative number for GLS)
Time frame: 5 years
Echocardiographic diastolic function based on i) left atrial volume index {ml/m^2).
Time frame: 5 years
Echocardiographic diastolic function based on ii) mitral annular velocities {cm/sec}
Time frame: 5 years
Echocardiographic diastolic function based on iii) mitral inflow velocities {cm/sec}
Time frame: 5 years
Echocardiographic diastolic function based on iv) ricuspid regurgitation velocity {cm/sec}
Time frame: 5 years
Echocardiographic diastolic function based on v) E/è-ratio
Time frame: 5 years
Investigate for prognotisc value and if it can be a marker of diastolic dysfunction. Unit of velocity measurement is m/sec.
Norwegian University of Science and Technology
Other
Myocardial Fibrosis With High Frame Rate Echocardiography in Patients With Aortic Stenosis - A Follow-up Study
Acronym: SAS-F-5
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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