Myocardial Blood Volume Measurement by Real-Time Myocardial Perfusion Echocardiography Correlates to Myocardial Compressibility by Cardiac Magnetic Resonance Imaging in Healthy Subjects

April 6, 2022 updated by: Courtney E. Bennett, Mayo Clinic
This study is being done to find out the normal amount of blood within the heart muscle and the variations in this blood flow between a cardiac MRI and TTE.

Study Overview

Study Type

Interventional

Enrollment (Actual)

115

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

    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • Available for testing performed in Rochester, MN.
  • Willing to undergo both an echocardiogram with RTMPE and CMR.
  • Study subject providing consent.

Exclusion Criteria:

  • Adults < 18 years.
  • BMI <30 kg/m^2.
  • Hypertension.
  • Diabetes Mellitus.
  • Stroke.
  • Cardiomyopathy or structural heart disease.
  • Known coronary artery disease or history of myocardial infarction.
  • Contraindication to echo enhancement agent or gadolinium administration such as an allergy.
  • Renal GFR < 50 mL/mL.
  • Females who are pregnant.
  • Subject unwilling to consent.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy adults
Healthy adults will have blood flow to the heart evaluated using s Real-Time Myocardial Echocardiography (RTMPE) and magnetic resonance image (MRI) to the heart.
Uses sound waves (ultrasound) to produce an images of the heart. During RTMPE a microbubble contrast agent is administered through an intravenous line (IV) to make the images of your heart clearer.
Imaging that focuses on the heart or blood vessels to assess size and function of the heart's chambers, thickness and movement of the walls of the heart, and blood flow in the blood vessels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial blood volume
Time Frame: Baseline
Ratio in systole and diastole (MBVs/MBVd) by real-time myocardial perfusion echocardiography (RTMPE)
Baseline

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Courtney Bennett, D.O., Mayo Clinic

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.

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)

February 9, 2021

Primary Completion (Actual)

November 11, 2021

Study Completion (Actual)

November 11, 2021

Study Registration Dates

First Submitted

January 22, 2021

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 26, 2021

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 20-000936

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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