Back to resultsPerfusion Imaging With Myocardial Contrast Echocardiography in HCM
Primary Purpose
Hypertrophic Cardiomyopathy
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Echo and myocardial contrast echocardiography perfusion imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypertrophic Cardiomyopathy
Eligibility Criteria
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
Sites / Locations
- Oregon Health & Science University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with HCM
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT02560467
First Posted
September 22, 2015
Last Updated
June 5, 2019
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT02560467
Brief Title
Perfusion Imaging With Myocardial Contrast Echocardiography in HCM
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
September 1, 2019 (Anticipated)
Study Completion Date
September 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Cardiomyopathy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with HCM
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Echo and myocardial contrast echocardiography perfusion imaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
Myocardial perfusion (ml/min/g) in the hypertrophied segment on myocardial contrast echo
Description
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.
Time Frame
One hour
Title
Myocardial blood flow reserve in the hypertrophied segment on myocardial contrast echo
Description
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.
Time Frame
One hour
Secondary Outcome Measure Information:
Title
Spatial distribution of blood flow on myocardial contrast echocardiography
Description
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).
Time Frame
One hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
36117179
Citation
Roldan P, Ravi S, Hodovan J, Belcik JT, Heitner SB, Masri A, Lindner JR. Myocardial contrast echocardiography assessment of perfusion abnormalities in hypertrophic cardiomyopathy. Cardiovasc Ultrasound. 2022 Sep 19;20(1):23. doi: 10.1186/s12947-022-00293-2.
Results Reference
derived
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Perfusion Imaging With Myocardial Contrast Echocardiography in HCM
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