Imaging Assessment of Diastolic Function
Combined Echocardiographic and MRI Assessment of Diastolic Function in Patients With Congenital Heart Disease
1 other identifier
interventional
200
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2012
CompletedFirst Posted
Study publicly available on registry
August 20, 2012
CompletedJune 24, 2016
June 1, 2016
August 13, 2012
June 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Atrial Volumes
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.
Day 1
Secondary Outcomes (2)
Assess Ventricular Volumes
Day 1
Myocardial Scarring
Day 1
Study Arms (2)
Magnetic Resonance Imaging (MRI)
EXPERIMENTALSubjects with congenital heart disease will undergo an echocardiograph, as well as an MRI.
Echocardiograph
EXPERIMENTALSubjects with congenital heart disease will undergo an echocardiograph, as well as an MRI.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Lack of informed consent
- Need for general anesthesia
- Similar contraindications as for a clinical MRI study apply.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luc Mertens, MD
The Hospital for Sick Children
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Cardiologist
Study Record Dates
First Submitted
August 13, 2012
First Posted
August 20, 2012
Last Updated
June 24, 2016
Record last verified: 2016-06