Assessment of Myocardial Tissue Damage in Aortic Stenosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Mayo Clinic
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Hari P. Chaliki M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02101619
First received: March 28, 2014
Last updated: April 1, 2014
Last verified: March 2014
  Purpose

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
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 Mayo Clinic:

Primary Outcome Measures:
  • Presence of myocardial fibrotic change determined by MRI. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2013
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Moderate aortic stenosis.
Severe aortic stenosis.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients referred for echocardiography in Mayo Clinic.

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02101619

Contacts
Contact: Minako Katayama, MD 480-301-9063 katayama.minako@mayo.edu
Contact: Michaele Menghini 480-301-6651 menghini.michaele@mayo.edu

Locations
United States, Arizona
Mayo Clinic Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Minako Katayama, MD    480-301-9063    katayama.minako@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
American Heart Association
Investigators
Principal Investigator: Hari Chaliki, MD Mayo Clinic
Principal Investigator: Minako Katayama, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Hari P. Chaliki M.D., MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02101619     History of Changes
Other Study ID Numbers: 13-004385
Study First Received: March 28, 2014
Last Updated: April 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
aortic stenosis
myocardial tissue
echocardiography
MRI

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

ClinicalTrials.gov processed this record on July 29, 2014