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

Tracking Information

First Received Date ^ICMJE

August 13, 2012

Last Updated Date

August 14, 2012

Start Date ^ICMJE

May 2010

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01668264 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Imaging Assessment of Diastolic Function

Official Title ^ICMJE

Combined Echocardiographic and MRI Assessment of Diastolic Function in Patients With Congenital Heart Disease

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Congenital Heart Disease

Intervention ^ICMJE

Procedure: Echocardiograph
Procedure: Magnetic Resonance Imaging (MRI)

Study Arm (s)

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)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

December 2015

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

up to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Luc Mertens, MD

(416)813-7418

luc.mertens@sickkids.ca

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01668264

Other Study ID Numbers ^ICMJE

1000017963

Has Data Monitoring Committee

Responsible Party

The Hospital for Sick Children

Study Sponsor ^ICMJE

The Hospital for Sick Children

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Luc Mertens, MD

The Hospital for Sick Children

Information Provided By

The Hospital for Sick Children

Verification Date

August 2012

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

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