Utility of MRI With Doppler Ultrasound Gating for Advanced Fetal Monitoring

NCT ID: NCT03541291

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-30

Study Completion Date

2024-03-22

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Heart Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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SMART-SYNC LM03

All participants

Group Type EXPERIMENTAL

SMART-SYNC LM03

Intervention Type DEVICE

Doppler ultrasound cardiac gating device for fetal MRI application

Interventions

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SMART-SYNC LM03

Doppler ultrasound cardiac gating device for fetal MRI application

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Mike Seed

Qualified Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mike Seed, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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1000055684

Identifier Type: -

Identifier Source: org_study_id

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