- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04724304
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
Status
Completed
Conditions
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.
Helpful Links
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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