Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571175
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Quantification of Myocardial Fibrosis in Aortis Stenosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Myocardial Fibrosis With High Frame Rate Echocardiography in Patients With Aortic Stenosis - A Follow-up Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAS-F-5
Brief Summary:
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
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
Detailed Description:
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 andor 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
Principle An elastic medium the left ventricle is incited by a force naturally occuring mechanical wave generated by atrial contraction andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None