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T1 Mapping of Diffuse Myocardial Fibrosis in Congenital Heart Disease

NCT02350829 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2019-09-19

No results posted yet for this study

Summary

Diffuse fibrosis (or scarring) of the heart muscle is found in a variety of congenital heart diseases and in cardiomyopathies (heart muscle disease), and is considered a mediator of decreased cardiac function. The detection and quantification of diffuse myocardial fibrosis has recently become feasible non-invasively, using cardiac magnetic resonance (CMR), applying a new technique labeled T1 mapping. With this technique, the part of the heart tissue which is not made up of muscle cells (extracellular volume) can be quantified, as long as the individual's hematocrit (cellular volume in the blood) is known. The extracellular volume in the heart tissue is regarded as a quantifiable marker for the extent of diffuse myocardial fibrosis.

In the proposed study this new T1 mapping technique shall be applied in patients with different forms of congenital heart disease (n=130), cardiomyopathies (n=40) and in control subjects (n=30). The additional scan time due to participation in the study will be approximately 5-10 minutes, without changing the clinical protocol.

The main objective is to study the presence and extent of myocardial fibrosis by T1 mapping CMR in pediatric patients with congenital heart disease and cardiomyopathies, in comparison to cardiovascularly healthy controls.

Conditions

Interventions

OTHER

Cardiac magnetic resonance sequence T1 mapping

Adding T1 mapping sequence to the clinical cardiac magnetic resonance scan Obtaining bloodwork for assessment of hematocrit and collagen biomarkers

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Lars Grosse-Wortmann, MD · The Hospital for Sick Children

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02350829 on ClinicalTrials.gov