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NCT03541291 Clinical Trial

Utility of MRI With Doppler Ultrasound Gating for Advanced Fetal Monitoring

Congenital Heart Disease Clinical Trial

Official title:
Utility of MRI With Doppler Ultrasound Gating for Advanced Fetal Monitoring

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03541291
Other study ID # 1000055684
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 30, 2018
Est. completion date March 22, 2024

Study information
Verified date March 2024
Source The Hospital for Sick Children
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 3
Est. completion date March 22, 2024
Est. primary completion date March 22, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• SMART-SYNC LM03
Doppler ultrasound cardiac gating device for fetal MRI application

Locations
Country Name City State
Canada The Hospital for Sick Children Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. within 2 weeks of participation in the study
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