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Imaging Techniques for Congenital Heart Disease

Phase 2
Waitlist Available
Led By Luc Mertens, MD
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
All patients with tetralogy of Fallot post repair, transposition of great arteries after arterial switch operation, aortic valvulopathy (aortic stenosis and aortic regurgitation), coarctation of the aorta and cardiomyopathy, who are planned to undergo a cardiac MRI will be eligible.
Be younger than 65 years old
Must not have
Need for general anesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how well different techniques measure diastolic function in children with congenital heart disease, in order to better understand and treat the condition.

Who is the study for?
This trial is for children with certain heart conditions like repaired tetralogy of Fallot, transposition of the great arteries post-surgery, aortic valve problems, narrowed aorta, and cardiomyopathy. They must be scheduled for a cardiac MRI and have given informed consent. It's not suitable for those who can't give consent or need general anesthesia.
What is being tested?
The study compares two heart imaging methods: Cardiac MRI and Echocardiography. The goal is to better understand how different parts of the heart work together in kids with congenital or acquired heart diseases by looking at chamber size, muscle mass changes, twisting motions during beats, and scar tissue.
What are the potential side effects?
There are generally no direct side effects from undergoing an MRI or echocardiograph as they are non-invasive imaging techniques. However, there might be discomfort due to the length of time needed to stay still during the procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a heart condition and am scheduled for a cardiac MRI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I will need general anesthesia for my procedure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Atrial Volumes
Secondary study objectives
Assess Ventricular Volumes
Myocardial Scarring

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Magnetic Resonance Imaging (MRI)Experimental Treatment2 Interventions
Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI.
Group II: EchocardiographExperimental Treatment2 Interventions
Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging (MRI)
2015
Completed Phase 4
~1800

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
711 Previous Clinical Trials
6,958,080 Total Patients Enrolled
Luc Mertens, MDPrincipal InvestigatorThe Hospital for Sick Children

Media Library

Echocardiograph Clinical Trial Eligibility Overview. Trial Name: NCT01668264 — Phase 2
Congenital Heart Disease Research Study Groups: Echocardiograph, Magnetic Resonance Imaging (MRI)
Congenital Heart Disease Clinical Trial 2023: Echocardiograph Highlights & Side Effects. Trial Name: NCT01668264 — Phase 2
Echocardiograph 2023 Treatment Timeline for Medical Study. Trial Name: NCT01668264 — Phase 2
~133 spots leftby Dec 2025
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