Assessment of Myocardial Tissue Damage in Aortic Stenosis

NCT02101619 | Completed

• 1 other identifier: 13-004385
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis

Keywords

aortic stenosis; myocardial tissue; echocardiography; MRI

Outcome Measures

Primary Outcomes (1)

• Presence of myocardial fibrotic change determined by MRI.

  1 hour

Study Arms (2)

Moderate aortic stenosis.

Severe aortic stenosis.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for echocardiography in Mayo Clinic.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• American Heart Association: collaborator

Study Sites (1)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Hari Chaliki, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Minako Katayama, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 2, 2014
• Study Start: August 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 17, 2016

Record last verified: 2016-08

Locations

US (1)