Imaging Assessment of Diastolic Function

NCT ID: NCT01668264

Last Updated: 2016-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congenital Heart Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Magnetic Resonance Imaging (MRI)

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

Group Type EXPERIMENTAL

Echocardiograph

Intervention Type PROCEDURE

Magnetic Resonance Imaging (MRI)

Intervention Type PROCEDURE

Echocardiograph

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

Group Type EXPERIMENTAL

Echocardiograph

Intervention Type PROCEDURE

Magnetic Resonance Imaging (MRI)

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Echocardiograph

Intervention Type PROCEDURE

Magnetic Resonance Imaging (MRI)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Luc Mertens

Staff Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Luc Mertens, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Luc Mertens, MD

Role: CONTACT

(416)813-7418

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Luc Mertens, MD

Role: primary

(416)813-7418

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1000017963

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Value of MRI in Congenital Heart Disease
NCT06752187 NOT_YET_RECRUITING