Text Size

Imaging Assessment of Diastolic Function

This study is currently recruiting participants.
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
History of Changes
  Purpose

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

Condition Intervention Phase
Congenital Heart Disease
 Procedure: Echocardiograph
Procedure: Magnetic Resonance Imaging (MRI)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Combined Echocardiographic and MRI Assessment of Diastolic Function in Patients With Congenital Heart Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: May 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Magnetic Resonance Imaging (MRI)
Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI.
 Procedure: Echocardiograph Procedure: Magnetic Resonance Imaging (MRI)
Experimental: Echocardiograph
Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI.
 Procedure: Echocardiograph Procedure: Magnetic Resonance Imaging (MRI)

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668264

Contacts
Contact: Luc Mertens, MD (416)813-7418 luc.mertens@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Luc Mertens, MD     (416)813-7418     luc.mertens@sickkids.ca    
Principal Investigator: Luc Mertens, MD            
Sub-Investigator: Andreea Dragulescu, MD            
Sub-Investigator: Lars Grosse-Wortmann, MD            
Sub-Investigator: Shi-Joon Yoo, MD            
Sub-Investigator: Edgar Jaeggi, MD            
Sub-Investigator: Mark Friedberg, MD            
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Luc Mertens, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01668264     History of Changes
Other Study ID Numbers: 1000017963
Study First Received: August 13, 2012
Last Updated: August 14, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Pediatrics
Congenital Heart Disease
Diastolic Function
Echocardiograph
MRI

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 16, 2013