Utility of MRI With Doppler Ultrasound Gating for Advanced Fetal Monitoring

March 22, 2024 updated by: Mike Seed, The Hospital for Sick Children
We will test an ultrasound device that uses sound waves to detect the fetal heart beat, and use this device to tell the MRI scanner when to collect pictures of the fetal heart. This will help freeze motion of the fetal heart, to make MRI pictures sharper. This will be important for assessing human fetal heart disease, an active area of research at our institution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

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

Yes

Description

Inclusion Criteria:

  • pregnant adults (age 18 and up) with fetus affected by congenital heart disease
  • singleton pregnancy in their 2nd and 3rd trimesters
  • scheduled for a clinical fetal ultrasound examination at the Fetal Echocardiography Clinic at SickKids

Exclusion Criteria:

  • claustrophobia
  • cardiac pacemaker
  • non-MRI compatible implants
  • non-singleton pregnancy
  • obesity (BMI > 30)

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SMART-SYNC LM03
All participants
Device: SMART-SYNC LM03
Doppler ultrasound cardiac gating device for fetal MRI application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between fetal MRI and fetal echocardiography
Time Frame: within 2 weeks of participation in the study
Anatomic MR images of the fetal heart will be acquired using prospective gating information from the Doppler ultrasound probe (SMART-SYNC LM03) and used to calculate ejection fraction. These values will be compared with corresponding reference values obtained during the patient's visit to the Fetal Echocardiography Clinic.
within 2 weeks of participation in the study

Collaborators and Investigators

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

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Mike Seed, MD, The Hospital for Sick Children

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)

May 30, 2018

Primary Completion (Actual)

March 22, 2024

Study Completion (Actual)

March 22, 2024

Study Registration Dates

First Submitted

May 18, 2018

First Submitted That Met QC Criteria

May 18, 2018

First Posted (Actual)

May 30, 2018

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000055684

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

product manufactured in and exported from the U.S.

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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