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Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis

NCT ID: NCT03422770

Last Updated: 2023-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-09

Study Completion Date

2020-06-30

Brief Summary

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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:

* 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

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Detailed Description

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Conditions

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Aortic Valve Stenosis Myocardial Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

All participants will undergo 'echo', bloodtests and MRI. Participating patients will in addition undergo electrocardiogram (ECG/Holter ECG) and 6 min walking test.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors
Analysis will be blinded

Study Groups

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Mild aortic stenosis

25 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.

Group Type OTHER

Echocardiography

Intervention Type 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.

MRI

Intervention Type DIAGNOSTIC_TEST

Cardiac MRI will be performed. In all patients without contraindications a gadolinium-based contrast agent will be given.

Blood test

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

ECG/Holter-ECG will be performed, and the findings will be related to the imaging findings.

6 min walking test

Intervention Type DIAGNOSTIC_TEST

6 MWT will be performed, and the findings will be related to findings from MRI/echocardiography.

Moderate aortic stenosis

25 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.

Group Type OTHER

Echocardiography

Intervention Type 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.

MRI

Intervention Type DIAGNOSTIC_TEST

Cardiac MRI will be performed. In all patients without contraindications a gadolinium-based contrast agent will be given.

Blood test

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

ECG/Holter-ECG will be performed, and the findings will be related to the imaging findings.

6 min walking test

Intervention Type DIAGNOSTIC_TEST

6 MWT will be performed, and the findings will be related to findings from MRI/echocardiography.

Severe aortic stenosis

50 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.

Group Type OTHER

Echocardiography

Intervention Type 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.

MRI

Intervention Type DIAGNOSTIC_TEST

Cardiac MRI will be performed. In all patients without contraindications a gadolinium-based contrast agent will be given.

Blood test

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

ECG/Holter-ECG will be performed, and the findings will be related to the imaging findings.

6 min walking test

Intervention Type DIAGNOSTIC_TEST

6 MWT will be performed, and the findings will be related to findings from MRI/echocardiography.

Controls

31 subjects, all undergoing echocardiography and blood test and MRI.

Group Type OTHER

Echocardiography

Intervention Type 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.

MRI

Intervention Type DIAGNOSTIC_TEST

Cardiac MRI will be performed. In all patients without contraindications a gadolinium-based contrast agent will be given.

Blood test

Intervention Type 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.

Interventions

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Echocardiography

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.

Intervention Type DIAGNOSTIC_TEST

MRI

Cardiac MRI will be performed. In all patients without contraindications a gadolinium-based contrast agent will be given.

Intervention Type DIAGNOSTIC_TEST

Blood 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.

Intervention Type DIAGNOSTIC_TEST

ECG and Holter-ECG

ECG/Holter-ECG will be performed, and the findings will be related to the imaging findings.

Intervention Type DIAGNOSTIC_TEST

6 min walking test

6 MWT will be performed, and the findings will be related to findings from MRI/echocardiography.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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GE Vingmed ultrasound scanner e95, 2017 Magnetic resonance imaging

Eligibility Criteria

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Inclusion Criteria

* Able to undergo protocolled investigations
* Patients: Mild, moderate or severe AS

Exclusion Criteria

* Renal insufficiency
* Previously myocardial infarction (ECG, echocardiogram or hospital record)
* Severe valvular heart disease (except patients)
* Other cardiac disease known to cause myocardial fibrosis
* Severe hypertension
* Other medical conditions deterring protocolled investigation and follow-up
* Other medical conditions affecting 5-yrs prognosis (cancer, pulmonary disease)
* Severely reduced image-quality (echocardiography and MRI)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Svend Aakhus, MD PhD

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Brage Høyem Amundsen, MD PhD

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

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Department of Circulation and Medical Imaging

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 37676209 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32861651 (View on PubMed)

Other Identifiers

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2017/1068

Identifier Type: -

Identifier Source: org_study_id

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