Assessment of Myocardial Tissue Damage in Aortic Stenosis

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. Identifier: NCT02101619
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : August 17, 2016
American Heart Association
Information provided by (Responsible Party):
Hari P. Chaliki M.D., Mayo Clinic

Brief Summary:

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.

Condition or disease
Aortic Stenosis

Study Type : Observational
Actual Enrollment : 59 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Myocardial Tissue Damage in Aortic Stenosis for Risk Stratification
Study Start Date : August 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Moderate aortic stenosis.
Severe aortic stenosis.

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

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.

Ages Eligible for Study:   65 Years and older   (Older Adult)
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

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 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

Responsible Party: Hari P. Chaliki M.D., MD, Mayo Clinic Identifier: NCT02101619     History of Changes
Other Study ID Numbers: 13-004385
First Posted: April 2, 2014    Key Record Dates
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