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Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis

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ClinicalTrials.gov Identifier: NCT03422770
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : February 1, 2019
Sponsor:
Collaborators:
St. Olavs Hospital
Oslo University Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Myocardial Fibrosis Diagnostic Test: Echocardiography Diagnostic Test: MRI Diagnostic Test: Blood test Diagnostic Test: ECG and Holter-ECG Diagnostic Test: 6 min walking test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All participants will undergo 'echo', bloodtests and MRI. Participating patients will in addition undergo electrocardiogram (ECG/Holter ECG) and 6 min walking test.
Masking: Single (Outcomes Assessor)
Masking Description: Analysis will be blinded
Primary Purpose: Diagnostic
Official Title: Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis
Actual Study Start Date : January 9, 2018
Estimated Primary Completion Date : January 2031
Estimated Study Completion Date : January 2031

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Mild aortic stenosis
25 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG.
Diagnostic Test: 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.
Other Name: GE Vingmed ultrasound scanner e95, 2017

Diagnostic Test: MRI
Cardiac MRI will be performed. In all patients without contraindications a gadolinium-based contrast agent will be given.
Other Name: Magnetic resonance imaging

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.

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

Diagnostic Test: 6 min walking 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.
Diagnostic Test: 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.
Other Name: GE Vingmed ultrasound scanner e95, 2017

Diagnostic Test: MRI
Cardiac MRI will be performed. In all patients without contraindications a gadolinium-based contrast agent will be given.
Other Name: Magnetic resonance imaging

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.

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

Diagnostic Test: 6 min walking 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.
Diagnostic Test: 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.
Other Name: GE Vingmed ultrasound scanner e95, 2017

Diagnostic Test: MRI
Cardiac MRI will be performed. In all patients without contraindications a gadolinium-based contrast agent will be given.
Other Name: Magnetic resonance imaging

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.

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

Diagnostic Test: 6 min walking test
6 MWT will be performed, and the findings will be related to findings from MRI/echocardiography.

Controls
100 subjects, all undergoing echocardiography and blood test, 30 undergoing MRI.
Diagnostic Test: 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.
Other Name: GE Vingmed ultrasound scanner e95, 2017

Diagnostic Test: MRI
Cardiac MRI will be performed. In all patients without contraindications a gadolinium-based contrast agent will be given.
Other Name: Magnetic resonance imaging

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.




Primary Outcome Measures :
  1. Cardiovascular morbidity and mortality [ Time Frame: 1 + 3 year ]
    Admission with heart failure or death caused by cardiac disease ('major adverse cardiac events' MACE)


Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 3 years ]
    Mortality in general

  2. Time of first re-hospitalisation [ Time Frame: 3 years ]
    Time of first re-hospitalisation after inclusion

  3. Cardiac systolic function [ Time Frame: 1 year. ]
    Echocardiographic systolic function based on left ventricular ejection fraction, global longitudinal strain, mitral annular plane systolic excursion (MAPSE)

  4. Cardiac diastolic function [ Time Frame: 1 year. ]
    Echocardiographic diastolic function based on the volume of the left atrium, the tricuspidal regurgitation, mitral annular velocities and mitral flow



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422770


Contacts
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Contact: Svend Aakhus, MD PhD +47 72828072 svend.aakhus@ntnu.no
Contact: Torvald Espeland, MD +47 99703156 torvald.espeland@ntnu.no

Locations
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Norway
Department of Circulation and Medical Imaging Recruiting
Trondheim, Norway
Contact: Torvald Espeland, MD       torvald.espeland@ntnu.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Oslo University Hospital
Investigators
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Study Director: Svend Aakhus, MD PhD Norwegian University of Science and Technology
Study Director: Brage Høyem Amundsen, MD PhD Norwegian University of Science and Technology

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03422770     History of Changes
Other Study ID Numbers: 2017/1068
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Myocardium
Predictive Value of Tests
Prognosis
Clinical Decision-making
Heart Ventricles
Echocardiography

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Fibrosis
Constriction, Pathologic
Pathologic Processes
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction