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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
| Oslo University Hospital | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild aortic stenosis | Other | 25 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control. |
|
| Moderate aortic stenosis | Other | 25 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control. |
|
| Severe aortic stenosis | Other | 50 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control. |
|
| Controls | Other | 31 subjects, all undergoing echocardiography and blood test and MRI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiography | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular morbidity and mortality | Admission with heart failure or death caused by cardiac disease ('major adverse cardiac events' MACE) | 1 + 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | Mortality in general | 3 years |
| Time of first re-hospitalisation | Time of first re-hospitalisation after inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Svend Aakhus, MD PhD | Norwegian University of Science and Technology | Study Director |
| Brage Høyem Amundsen, MD PhD | Norwegian University of Science and Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Circulation and Medical Imaging | Trondheim | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37676209 | Derived | 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. | |
| 32861651 | Derived |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| D008279 | Magnetic Resonance Imaging |
| D006403 | Hematologic Tests |
| D015716 | Electrocardiography, Ambulatory |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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All participants will undergo 'echo', bloodtests and MRI. Participating patients will in addition undergo electrocardiogram (ECG/Holter ECG) and 6 min walking test.
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Analysis will be blinded
|
|
| 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. Blood samples will be analyzed for markers of myocardial fibrosis at Oslo University Hospital.The findings will be related to imaging findings. |
|
| 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 MRI/echocardiography. |
|
| 3 years |
| Cardiac systolic function | Echocardiographic systolic function based on left ventricular ejection fraction, global longitudinal strain, mitral annular plane systolic excursion (MAPSE) | 1 year. |
| Cardiac diastolic function | Echocardiographic diastolic function based on the volume of the left atrium, the tricuspidal regurgitation, mitral annular velocities and mitral flow | 1 year. |
| 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. |
| D014694 |
| Ventricular Outflow Obstruction |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D014054 | Tomography |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D004562 | Electrocardiography |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |