Healthy AdultsNCT04724304
Myocardial Blood Volume Measurement by Real-Time Myocardial Perfusion Echocardiography Correlates to Myocardial Compressibility by Cardiac Magnetic Resonance Imaging in Healthy Subjects
A study testing Real-Time Myocardial Echocardiography (RTMPE) and Magnetic resonance image (MRI) in people with Healthy Adults, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Real-Time Myocardial Echocardiography (RTMPE) and Magnetic resonance image (MRI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2021to 11 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Available for testing performed in Rochester, MN.
- Willing to undergo both an echocardiogram with RTMPE and CMR.
- Study subject providing consent.
Who cannot join
- Adults < 18 years.
- BMI <30 kg/m^2.
- Hypertension.
- Diabetes Mellitus.
- Stroke.
- Cardiomyopathy or structural heart disease.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy Adults
- Being tested
- Real-Time Myocardial Echocardiography (RTMPE), Magnetic resonance image (MRI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-Time Myocardial Echocardiography (RTMPE)Diagnostic test
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.
Magnetic resonance image (MRI)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Experimental | 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. Receives: Diagnostic Test: Real-Time Myocardial Echocardiography (RTMPE); Diagnostic Test: Magnetic resonance image (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial blood volume
Ratio in systole and diastole (MBVs/MBVd) by real-time myocardial perfusion echocardiography (RTMPE)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start9 Feb 2021
- Primary completion11 Nov 2021
- Study completion11 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Courtney E. Bennett, Mayo Clinic
- Investigators
- Courtney Bennett, D.O., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724304
- Sponsor's protocol ID
- 20-000936
- Status last verified
- Apr 2022
- First submitted
- 22 Jan 2021
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Blood Volume Measurement by Real-Time Myocardial Perfusion Echocardiography Correlates to Myocardial Compressibility by Cardiac Magnetic Resonance Imaging in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04724304
- Acronym / sponsor ID
- 20-000936
- Conditions
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 11 Nov 2021 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | Experimental | Diagnostic Test: Real-Time Myocardial Echocardiography (RTMPE), Diagnostic Test: Magnetic resonance image (MRI)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Available for testing performed in Rochester, MN.
- Willing to undergo both an echocardiogram with RTMPE and CMR.
- Study subject providing consent.
Key exclusion criteria (11 listed)
- Adults < 18 years.
- BMI <30 kg/m^2.
- Hypertension.
- Diabetes Mellitus.
- Stroke.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-Time Myocardial Echocardiography (RTMPE)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. | Diagnostic test | Healthy adults |
| Magnetic resonance image (MRI)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. | Diagnostic test | Healthy adults |
Primary outcome
Myocardial blood volume
Time frame: Baseline
Ratio in systole and diastole (MBVs/MBVd) by real-time myocardial perfusion echocardiography (RTMPE)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Courtney Bennett, D.O. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-Time Myocardial Echocardiography (RTMPE) and Magnetic resonance image (MRI) in people with Healthy Adults, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial blood volume (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.