Perfusion Imaging With Myocardial Contrast Echocardiography in HCM

Not Applicable

• Conditions: Hypertrophic Cardiomyopathy
• Interventions: Drug: Echo and myocardial contrast echocardiography perfusion imaging

• Registration Number: NCT02560467
• Lead Sponsor: Oregon Health and Science University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-09-22
• Study First Submitted QC: 2015-09-23
• Study First Posted: 2015-09-25
• Study Start: 2015-12-01
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-05
• Last Update Posted: 2019-06-06
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Age 18-80 years
• Established diagnosis of HCM

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with HCM	Echo and myocardial contrast echocardiography perfusion imaging	This is a prospective, non-blinded single center study. Subjects with known HCM with variant will be recruited. MCE at rest and during vasodilator stress will be performed. Full echocardiography including for diastolic function and regional strain imaging will also be performed. Patient history and questionnaires will be used for evaluation of symptoms and arrhythmias.

Primary Outcome Measures

Name	Time	Method
Myocardial perfusion (ml/min/g) in the hypertrophied segment on myocardial contrast echo	One hour	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.
Myocardial blood flow reserve in the hypertrophied segment on myocardial contrast echo	One hour	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.

Secondary Outcome Measures

Name	Time	Method
Spatial distribution of blood flow on myocardial contrast echocardiography	One hour	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).

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States