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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
| Oslo University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aortic stenosis | Mild aortic stenosis:25 patients were included at baseline, and those that still avoid exclusion criteria, will be invited to undergo repeat echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. Moderate aortic stenosis: 25 patients were included at baseline, and those that still avoid exclusion criteria, will be invited to undergo repeat echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. Severe aortic stenosis: 50 patients were included at baseline, and those that still avoid exclusion criteria, will be invited to undergo repeat echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. |
| |
| Controls | The controls from baseline inclusion will be invited to undergo repeat echocardiography, blood test and CMRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High frame rate echocardiography | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular morbidity | Admissions with heart failure | 5 year |
| Cardiovascular mortality | Death caused by cardiac disease | 5 year |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | Mortality in general | 5 years |
| Time of first re-hospitalization | Time of first re-hospitalization after inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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Patients: Mild, moderate, or severe aortic valve stenosis. A subset of the patients will have undergone aortic valve replacement since inclusion.
Controls: Healthy with no valve disease, or other cardiac disease known to cause myocardial fibrosis
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| Name | Affiliation | Role |
|---|---|---|
| Brage H: Amundsen, MD, PhD | Norwegian University of Science and Technology (NTNU) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Olavs Hosptial | Trondheim | Trรธndelag | 7030 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32861651 | Background | Salles S, Espeland T, Molares A, Aase SA, Hammer TA, Stoylen A, Aakhus S, Lovstakken L, Torp H. 3D Myocardial Mechanical Wave Measurements: Toward In Vivo 3D Myocardial Elasticity Mapping. JACC Cardiovasc Imaging. 2021 Aug;14(8):1495-1505. doi: 10.1016/j.jcmg.2020.05.037. Epub 2020 Aug 26. | |
| Background | M. Mohajery, S. Salles, T. Espeland, S. Fadnes and L. Lovstakken, | ||
| 37676209 |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| D015716 | Electrocardiography, Ambulatory |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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|
|
| MRI | Diagnostic Test | Cardiac MRI will be performed. In all patients without contraindications, a gadolinium-based contrast agent will be given. |
|
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| Blood test | Diagnostic Test | Conventional brachial venous blood samples will be drawn. Hematocrit value {in %} will be used to calculate CMR-derived exttracellular volume (ECV) |
|
| ECG and Holter-ECG | Diagnostic Test | ECG/Holter-ECG will be performed, and the findings will be related to the imaging findings. |
|
| 6 min walking test | Diagnostic Test | 6 MWT will be performed, and the findings will be related to findings from CMRI/echocardiography. |
|
| 5 years |
| Cardiac systolic function | 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) | 5 years |
| Cardiac diastolic function (1 of 5) | Echocardiographic diastolic function based on i) left atrial volume index {ml/m^2). | 5 years |
| Cardiac diastolic function (2 of 5) | Echocardiographic diastolic function based on ii) mitral annular velocities {cm/sec} | 5 years |
| Cardiac diastolic function (3 of 5) | Echocardiographic diastolic function based on iii) mitral inflow velocities {cm/sec} | 5 years |
| Cardiac diastolic function (4 of 5) | Echocardiographic diastolic function based on iv) ricuspid regurgitation velocity {cm/sec} | 5 years |
| Cardiac diastolic function (5 of 5) | Echocardiographic diastolic function based on v) E/รจ-ratio | 5 years |
| Velocity of natural mechanical waves propagating through the myocardium | Investigate for prognotisc value and if it can be a marker of diastolic dysfunction. Unit of velocity measurement is m/sec. | 5 years |
| Result |
| Espeland T, Wigen MS, Dalen H, Berg EAR, Hammer TA, Salles S, Lovstakken L, Amundsen BH, Aakhus S. Mechanical Wave Velocities in Left Ventricular Walls in Healthy Subjects and Patients With Aortic Stenosis. JACC Cardiovasc Imaging. 2024 Feb;17(2):111-124. doi: 10.1016/j.jcmg.2023.07.009. Epub 2023 Sep 6. |
| D014694 |
| Ventricular Outflow Obstruction |
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |