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Perfusion Imaging With Myocardial Contrast Echocardiography in HCM

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02560467
Enrollment
10
Registered
2015-09-25
Start date
2015-12-01
Completion date
2019-09-15
Last updated
2019-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Cardiomyopathy

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.

Interventions

DRUGEcho 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.

Sponsors

Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Myocardial perfusion (ml/min/g) in the hypertrophied segment on myocardial contrast echoOne hourMyocardial 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 echoOne hourMyocardial 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

MeasureTime frameDescription
Spatial distribution of blood flow on myocardial contrast echocardiographyOne hourMyocardial 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026