Imaging Assessment of Diastolic Function

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01668264
First received: August 13, 2012
Last updated: August 14, 2012
Last verified: August 2012

August 13, 2012
August 14, 2012
May 2010
December 2015   (final data collection date for primary outcome measure)
Atrial Volumes [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01668264 on ClinicalTrials.gov Archive Site
  • Assess Ventricular Volumes [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.
  • Myocardial Scarring [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
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
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Congenital Heart Disease
  • Procedure: Echocardiograph
  • Procedure: Magnetic Resonance Imaging (MRI)
  • Experimental: Magnetic Resonance Imaging (MRI)
    Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI.
    Interventions:
    • Procedure: Echocardiograph
    • Procedure: Magnetic Resonance Imaging (MRI)
  • Experimental: Echocardiograph
    Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI.
    Interventions:
    • Procedure: Echocardiograph
    • Procedure: Magnetic Resonance Imaging (MRI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2015
December 2015   (final data collection date for primary outcome measure)

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.
Both
up to 18 Years
No
Contact: Luc Mertens, MD (416)813-7418 luc.mertens@sickkids.ca
Canada
 
NCT01668264
1000017963
No
The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Luc Mertens, MD The Hospital for Sick Children
The Hospital for Sick Children
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP