Assessment of Myocardial Tissue Damage in Aortic Stenosis
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|ClinicalTrials.gov Identifier: NCT02101619|
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : August 17, 2016
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|
|Study Type :||Observational|
|Actual Enrollment :||59 participants|
|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|
|Moderate aortic stenosis.|
|Severe aortic stenosis.|
- Presence of myocardial fibrotic change determined by MRI. [ Time Frame: 1 hour ]
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|
|Scottsdale, Arizona, United States, 85259|
|Principal Investigator:||Hari Chaliki, MD||Mayo Clinic|
|Principal Investigator:||Minako Katayama, MD||Mayo Clinic|