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Utility of MRI With Doppler Ultrasound Gating for Advanced Fetal Monitoring

Primary Purpose

Congenital Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SMART-SYNC LM03
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Congenital Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • The Hospital for Sick ChildrenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SMART-SYNC LM03

Arm Description

All participants

Outcomes

Primary Outcome Measures

Comparison between fetal MRI and fetal echocardiography
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.

Secondary Outcome Measures

Full Information

First Posted
May 18, 2018
Last Updated
October 26, 2022
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT03541291
Brief Title
Utility of MRI With Doppler Ultrasound Gating for Advanced Fetal Monitoring
Official Title
Utility of MRI With Doppler Ultrasound Gating for Advanced Fetal Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SMART-SYNC LM03
Arm Type
Experimental
Arm Description
All participants
Intervention Type
Device
Intervention Name(s)
SMART-SYNC LM03
Intervention Description
Doppler ultrasound cardiac gating device for fetal MRI application
Primary Outcome Measure Information:
Title
Comparison between fetal MRI and fetal echocardiography
Description
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.
Time Frame
within 2 weeks of participation in the study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natasha Milligan, BSc
Phone
416-818-6924
Email
natasha.milligan@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Seed, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natasha Milligan, BSc
Phone
416-586-4800
Ext
6416
Email
natasha.milligan@sickkids.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Utility of MRI With Doppler Ultrasound Gating for Advanced Fetal Monitoring

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