Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis

NCT03422770 | Completed

• 1 other identifier: 2017/1068
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aortic Valve Stenosis; Myocardial Fibrosis

Keywords

Myocardium; Predictive Value of Tests; Prognosis; Clinical Decision-making; Heart Ventricles; Echocardiography

Outcome Measures

Primary Outcomes (1)

• Cardiovascular morbidity and mortality

  Admission with heart failure or death caused by cardiac disease ('major adverse cardiac events' MACE)

  1 + 3 year

Secondary Outcomes (4)

• All cause mortality

  3 years

• Time of first re-hospitalisation

  3 years

• Cardiac systolic function

  1 year.

• Cardiac diastolic function

  1 year.

Study Arms (4)

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.

Diagnostic Test: Echocardiography; Diagnostic Test: MRI; Diagnostic Test: Blood test; Diagnostic Test: ECG and Holter-ECG; Diagnostic Test: 6 min walking test

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.

Diagnostic Test: Echocardiography; Diagnostic Test: MRI; Diagnostic Test: Blood test; Diagnostic Test: ECG and Holter-ECG; Diagnostic Test: 6 min walking test

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.

Diagnostic Test: Echocardiography; Diagnostic Test: MRI; Diagnostic Test: Blood test; Diagnostic Test: ECG and Holter-ECG; Diagnostic Test: 6 min walking test

Controls

OTHER

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

Diagnostic Test: Echocardiography; Diagnostic Test: MRI; Diagnostic Test: Blood test

Interventions

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.

Also known as: GE Vingmed ultrasound scanner e95, 2017

Controls; Mild aortic stenosis; Moderate aortic stenosis; Severe aortic stenosis

MRI DIAGNOSTIC_TEST

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

Also known as: Magnetic resonance imaging

Controls; Mild aortic stenosis; Moderate aortic stenosis; Severe aortic stenosis

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.

Controls; Mild aortic stenosis; Moderate aortic stenosis; Severe aortic stenosis

ECG and Holter-ECG DIAGNOSTIC_TEST

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

Mild aortic stenosis; Moderate aortic stenosis; Severe aortic stenosis

6 min walking test DIAGNOSTIC_TEST

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

Mild aortic stenosis; Moderate aortic stenosis; Severe aortic stenosis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

Department of Circulation and Medical Imaging

Trondheim, Norway

Location

Related Publications (2)

• 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.

  PMID: 37676209 DERIVED

• 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.

  PMID: 32861651 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Echocardiography; Magnetic Resonance Imaging; Hematologic Tests; Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Tomography; Clinical Laboratory Techniques; Investigative Techniques; Electrocardiography; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Analysis will be blinded
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: February 6, 2018
• Study Start: January 9, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)