Perfusion Imaging With Myocardial Contrast Echocardiography in HCM

NCT ID: NCT02560467

Last Updated: 2019-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-01
• Study Completion Date: 2019-09-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with HCM

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.

Group Type: EXPERIMENTAL

Echo and myocardial contrast echocardiography perfusion imaging

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Jonathan R. Lindner, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36117179 (View on PubMed)

Other Identifiers

15158

Identifier Type: -

Identifier Source: org_study_id