Utility of MRI With Doppler Ultrasound Gating for Advanced Fetal Monitoring

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SMART-SYNC LM03

Device

Doppler ultrasound cardiac gating device for fetal MRI application

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2024
Study completion: 2024
First posted: May 30, 2018
Registry last updated: Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed