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Imaging Assessment of Diastolic Function

Primary Purpose

Congenital Heart Disease

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Echocardiograph
Magnetic Resonance Imaging (MRI)
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Congenital Heart Disease focused on measuring Pediatrics, Congenital Heart Disease, Diastolic Function, Echocardiograph, MRI

Eligibility Criteria

1 Day - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Magnetic Resonance Imaging (MRI)

Echocardiograph

Arm Description

Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI.

Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Assess Ventricular Volumes
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
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.

Full Information

First Posted
August 13, 2012
Last Updated
June 22, 2016
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT01668264
Brief Title
Imaging Assessment of Diastolic Function
Official Title
Combined Echocardiographic and MRI Assessment of Diastolic Function in Patients With Congenital Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
Pediatrics, Congenital Heart Disease, Diastolic Function, Echocardiograph, MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Magnetic Resonance Imaging (MRI)
Arm Type
Experimental
Arm Description
Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI.
Arm Title
Echocardiograph
Arm Type
Experimental
Arm Description
Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI.
Intervention Type
Procedure
Intervention Name(s)
Echocardiograph
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging (MRI)
Primary Outcome Measure Information:
Title
Atrial Volumes
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Assess Ventricular Volumes
Description
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.
Time Frame
Day 1
Title
Myocardial Scarring
Description
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.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luc Mertens, MD
Phone
(416)813-7418
Email
luc.mertens@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Mertens, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc Mertens, MD
Phone
(416)813-7418
Email
luc.mertens@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Luc Mertens, MD
First Name & Middle Initial & Last Name & Degree
Andreea Dragulescu, MD
First Name & Middle Initial & Last Name & Degree
Lars Grosse-Wortmann, MD
First Name & Middle Initial & Last Name & Degree
Shi-Joon Yoo, MD
First Name & Middle Initial & Last Name & Degree
Edgar Jaeggi, MD
First Name & Middle Initial & Last Name & Degree
Mark Friedberg, MD

12. IPD Sharing Statement

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Imaging Assessment of Diastolic Function

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