Perfusion Imaging With Myocardial Contrast Echocardiography in HCM

NCT02560467 | Unknown DMC

• 1 other identifier: 15158
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Spatial distribution of blood flow on myocardial contrast echocardiography

  One hour

Study Arms (1)

Patients with HCM

EXPERIMENTAL

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.

Drug: Echo and myocardial contrast echocardiography perfusion imaging

Interventions

Echo and myocardial contrast echocardiography perfusion imaging DRUG

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.

Patients with HCM

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years
• Established diagnosis of HCM

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, United States

Location

Related Publications (1)

• 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.

  PMID: 36117179 DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

Caves

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Geological Phenomena; Physical Phenomena; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: September 25, 2015
• Study Start: December 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: September 15, 2019
• Last Updated: June 6, 2019

Record last verified: 2019-06

Locations

US (1)