Perfusion Imaging With Myocardial Contrast Echocardiography in HCM

Hypertrophic Cardiomyopathy Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02560467
• Other study ID #: 15158
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: September 15, 2019

Study information

• Verified date: June 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine whether myocardial contrast echocardiography in patients with cardiomyopathy (HCM) can detect resting hypo-perfusion due to fibrosis or stress induced perfusion defects due to associated abnormalities in intramyocardial arteries and the microcirculation. A secondary aim will be to determine whether abnormalities in perfusion are associated with either severity of symptoms (chest pain and dyspnea), presence of arrhythmias, and regional function of the septum.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: September 15, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18-80 years

• Established diagnosis of HCM

Exclusion Criteria:

• Known history of coronary or peripheral artery disease

• History of myocardial infarction

• Pregnant or lactating females

• Hypersensitivity to any ultrasound contrast agent

• Evidence right-to-left or bi-directional intracardiac shunt

• Moderate or greater valve disease other than from HCM (systolic anterior motion of the mitral valve)

• History of septal ablation or myectomy

• Hemodynamic instability

• Pacemaker dependent heart rhythm

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Intervention

Drug:
• Echo and myocardial contrast echocardiography perfusion imaging
Myocardial blood flow will be assessed by myocardial contrast echo. Perfusion at rest and stress will be quantified and compared to patient sx, degree of dysfunction on echo strain imaging, and degree of fibrosis on magnetic resonance imaging (when available) that was ordered as part of routine clinical care. Myocardial contrast echocardiography will be performed by intravenous administration of ultrasound contrast agent (Definity or Lumason) using FDA-approved dose limits. Vasodilator stress during MCE imaging will be performed using regadenoson at FDA-approved doses.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial perfusion (ml/min/g) in the hypertrophied segment on myocardial contrast echo	Myocardial contrast echo will be used to measure myocardial perfusion in ml/min/g of tissue in the hypertrophied segment. The data will be analyzed both in terms of absolute value of ml/min/g and also as a ration to normal tissue.	One hour
Primary	Myocardial blood flow reserve in the hypertrophied segment on myocardial contrast echo	Myocardial blood flow reserve on myocardial contrast echo (ratio of flow during hyperemia to rest) will be calculated for the hypertrophied segment and expressed as an absolute value and relative to normal segments.	One hour
Secondary	Spatial distribution of blood flow on myocardial contrast echocardiography	Myocardial contrast echocardiography performed at baseline will be analyzed using mathematical algorithms that define how "homogenous" or "heterogenous" blood flow distribution is in the hypertrophied segment. These values will be described by wavelet energy levels (dimensionless).	One hour