Imaging Assessment of Diastolic Function
Combined Echocardiographic and MRI Assessment of Diastolic Function in Patients With Congenital Heart Disease
Diastolic function is poorly studied in children with congenital heart disease. This is mainly due to the lack of validated techniques. Cardiac MRI offers two advantages compared to echocardiography: 1. accurate measurements of ventricular volumes and mass; 2. tissue characterization. The main advantage of echocardiography is a better temporal resolution which allows the study of short events like early relaxation. Overall there is a lack of studies correlating different echocardiographic and MRI parameters of heart function in pediatric populations with congenital or acquired heart diseases. This study will address specific questions on specific groups of patients that might bring more insight into chamber interaction and cardiac function. This study hypothesizes the following:
- Atrial enlargement is a marker of chronic increase in filling pressures and 3D echo might be the best method for follow-up.
- Cardiac remodeling associated with chronic loading results in changes in diastolic properties related to changes in cardiac mass and volume. This is related to changes in cardiac mechanics influencing diastolic parameters. Especially the influence on twisting and untwisting will be studied.
- Regional myocardial fibrosis and scarring may account for regional systolic and diastolic dysfunction with possible prognostic impact
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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.
- Informed consent
Exclusion Criteria:
- Lack of informed consent
- Need for general anesthesia
- Similar contraindications as for a clinical MRI study apply.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Magnetic Resonance Imaging (MRI)
Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI.
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Experimenteel: Echocardiograph
Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Atrial Volumes
Tijdsspanne: Day 1
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Measure right and left atrial volumes by 2D and 3D echo and correlate the different echocardiographic measurements with MRI.
This will allow identifying the most accurate measurement which can be used in clinical practice.
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Day 1
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Assess Ventricular Volumes
Tijdsspanne: Day 1
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Assess ventricular volumes and mass and calculate mass/volume ratio.
Study the effect of ventricular remodeling on myocardial mechanics especially twisting and untwisting.
Relate these changes to evaluation of diastolic function.
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Day 1
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Myocardial Scarring
Tijdsspanne: Day 1
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Assess the presence of myocardial scarring in specific populations with congenital heart disease and correlate the findings with regional and global systolic and diastolic dysfunction.
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Day 1
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Luc Mertens, MD, The Hospital for Sick Children
Studie record data
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1000017963
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