NCT04724304

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

February 9, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2021

Completed
Last Updated

April 7, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

January 22, 2021

Last Update Submit

April 6, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Myocardial blood volume

    Ratio in systole and diastole (MBVs/MBVd) by real-time myocardial perfusion echocardiography (RTMPE)

    Baseline

Study Arms (1)

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.

Diagnostic Test: Real-Time Myocardial Echocardiography (RTMPE)Diagnostic Test: Magnetic resonance image (MRI)

Interventions

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.

Healthy adults

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.

Healthy adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Courtney Bennett, D.O.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 22, 2021

First Posted

January 26, 2021

Study Start

February 9, 2021

Primary Completion

November 11, 2021

Study Completion

November 11, 2021

Last Updated

April 7, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations