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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1

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

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

Primary outcome measures

Atrial Volumes

Secondary outcome measures

Assess Ventricular Volumes

Myocardial Scarring

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor

686 Previous Clinical Trials

6,944,593 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

Frequently Asked Questions

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

What criteria must be met for someone to qualify as a participant in this research project?

"This medical trial seeks 200 individuals with congenital heart disease that are between one day and 18 years old."

Answered by AI

Has the FDA verified Echocardiograph as a safe and effective medical device?

"The current data surrounding echocardiograph's safety is deemed sufficient for the drug to receive a score of 2. Despite being in Phase 2, no evidence exists that supports its efficacy yet."

Answered by AI

Is this research endeavor enlisting participants who are of legal age?

"As this is a paediatric study, only individuals aged 1 Day to 18 are eligible. Clinicaltrials.gov registers 96 trials for minors and 268 trails designed for patients above the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Imaging Assessment of Diastolic Function

Luc Mertens 2024. "Imaging Assessment of Diastolic Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01668264.

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