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MRI with Doppler Ultrasound Gating for Congenital Heart Disease

N/A

Waitlist Available

Led By Christopher Macgowan, PhD

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pregnant adults (age 18 and up) with fetus affected by congenital heart disease

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 2 weeks of participation in the study

Awards & highlights

Study Summary

This trial will test an ultrasound machine that uses sound waves to detect the fetal heart beat. This information will be used to help MRI pictures of the fetal heart be sharper.

Who is the study for?

This trial is for pregnant adults over 18 with a single baby affected by congenital heart disease, in their second or third trimester, and scheduled for an ultrasound at the Fetal Echocardiography Clinic. It's not suitable for those with claustrophobia, cardiac pacemakers, non-MRI safe implants, multiple pregnancies, or obesity (BMI > 30).Check my eligibility

What is being tested?

The study tests a new ultrasound device called SMART-SYNC LM03 to improve MRI images of the fetal heart. The device syncs with the fetus's heartbeat to reduce motion blur during MRI scans, aiming to better assess fetal heart conditions.See study design

What are the potential side effects?

Since this trial involves non-invasive imaging techniques like MRI and Doppler Ultrasound Gating rather than drugs or surgery, significant side effects are not expected. However standard risks associated with MRIs such as discomfort from loud noises or lying still may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am pregnant and my unborn baby has been diagnosed with a heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 2 weeks of participation in the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 2 weeks of participation in the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 2 weeks of participation in the study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Comparison between fetal MRI and fetal echocardiography

Trial Design

1Treatment groups

Experimental Treatment

Group I: SMART-SYNC LM03Experimental Treatment1 Intervention

All participants

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SMART-SYNC LM03

2018

N/A

~10

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor

690 Previous Clinical Trials

6,945,475 Total Patients Enrolled

Christopher Macgowan, PhDPrincipal InvestigatorThe Hospital for Sick Children

Mike Seed, MDPrincipal InvestigatorThe Hospital for Sick Children

1 Previous Clinical Trials

25 Total Patients Enrolled

Media Library

SMART-SYNC LM03 Clinical Trial Eligibility Overview. Trial Name: NCT03541291 — N/A

Congenital Heart Disease Research Study Groups: SMART-SYNC LM03

Congenital Heart Disease Clinical Trial 2023: SMART-SYNC LM03 Highlights & Side Effects. Trial Name: NCT03541291 — N/A

SMART-SYNC LM03 2023 Treatment Timeline for Medical Study. Trial Name: NCT03541291 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are participating in this medical experiment?

"Affirmative. Clinicaltrials.gov presents evidence that this clinical research project, which was commencing on May 30th 2018, is actively recruiting individuals for participation. 20 participants need to be recruited at 1 medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Utility of MRI With Doppler Ultrasound Gating for Advanced Fetal Monitoring

Mike Seed 2018. "Utility of MRI With Doppler Ultrasound Gating for Advanced Fetal Monitoring". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03541291.