Perfusion Imaging With Myocardial Contrast Echocardiography in HCM

June 5, 2019 updated by: Jonathan R. Lindner, MD, Oregon Health and Science University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial perfusion (ml/min/g) in the hypertrophied segment on myocardial contrast echo
Time Frame: 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.
One hour
Myocardial blood flow reserve in the hypertrophied segment on myocardial contrast echo
Time Frame: 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.
One hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spatial distribution of blood flow on myocardial contrast echocardiography
Time Frame: 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).
One hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 15, 2019

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

September 23, 2015

First Posted (Estimate)

September 25, 2015

Study Record Updates

Last Update Posted (Actual)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15158

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertrophic Cardiomyopathy

Clinical Trials on Echo and myocardial contrast echocardiography perfusion imaging

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe