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Assessment of Myocardial Tissue Damage in Aortic Stenosis

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 2, 2014
Last Update Posted: August 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
American Heart Association
Information provided by (Responsible Party):
Hari P. Chaliki M.D., Mayo Clinic

Aortic stenosis (AS) is the most common valve disease in the United States and most common indication for valve replacement surgery. Anatomical and hemodynamic severity of AS is insufficient for elucidating patients' prognosis. Therefore, the decision about the optimal timing of surgical intervention remains critical. However, the changes in structure and electrical activity of the cardiac muscle can be assessed by noninvasive imaging and electrocardiography (ECG). Degenerative myocardial changes characterized by fibrosis or collagen deposits are frequently observed in AS patients and have a negative impact on patient outcomes. In this project, our objective is to determine whether echocardiographic image analysis of integrated backscatter (IB), which can express changes in myocardial tissue composition (amount of fibrosis) based on its ultrasound reflectivity, global left ventricular (LV) load as measured by Zva, and ECG analysis of the duration of the QRS interval have a role in risk stratification for AS patients and to apply those methods to identify which patients would benefit from surgical intervention.

The investigators hypothesize that 1) the severity of myocardial damage can discriminate the prognosis in patients with AS, and 2) IB, Zva, and QRS interval can be diagnostic measures of the severity of myocardial damage. The investigators will measure the severity of myocardial fibrosis using MRI (reference) in 50 patients and will test the diagnostic significance of IB (testing method). Zva, QRS duration, and conventional echocardiographic measures will also be tested for diagnosing severity of myocardial fibrosis.

Aortic Stenosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Myocardial Tissue Damage in Aortic Stenosis for Risk Stratification

Resource links provided by NLM:

Further study details as provided by Hari P. Chaliki M.D., Mayo Clinic:

Primary Outcome Measures:
  • Presence of myocardial fibrotic change determined by MRI. [ Time Frame: 1 hour ]

Enrollment: 59
Study Start Date: August 2013
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Moderate aortic stenosis.
Severe aortic stenosis.


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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred for echocardiography in Mayo Clinic.

Inclusion Criteria:

  • Moderate or severe aortic stenosis determined by echocardiography
  • Adults > 65 years old

Exclusion Criteria:

  • Ejection fraction < 50%
  • Valvular diseases of more than or equal to moderate degree other than aortic stenosis
  • Prior myocardial infarction or coronary artery disease needs revascularization
  • Atrial fibrillation (chronic)
  • Pacemaker/defibrillator implanted
  • Previous valve replacement performed
  • Cardiomyopathy(HCM, infiltrative cardiomyopathy, constriction)
  • Renal dysfunction (estimated GFR < 30ml/min/1.73m² or end stage renal failure)
  • Patients with contraindication for MRI
  • Patients with poor echocardiographic images
  Contacts and Locations
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): NCT02101619

United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
American Heart Association
Principal Investigator: Hari Chaliki, MD Mayo Clinic
Principal Investigator: Minako Katayama, MD Mayo Clinic
  More Information

Responsible Party: Hari P. Chaliki M.D., MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02101619     History of Changes
Other Study ID Numbers: 13-004385
First Submitted: March 28, 2014
First Posted: April 2, 2014
Last Update Posted: August 17, 2016
Last Verified: August 2016

Keywords provided by Hari P. Chaliki M.D., Mayo Clinic:
aortic stenosis
myocardial tissue

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