T1 Mapping of Diffuse Myocardial Fibrosis in Congenital Heart Disease

NCT02350829 | Completed

• 1 other identifier: 1000039963
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Measuring degree of diffuse myocardial fibrosis

  Participants will be followed for the duration of hospital visit, which is approximately 2 hours for the MRI part, and eventually longer, depending on possible other appointments on that day

  Once at the end of the visit

Study Arms (3)

Cardiomyopathy

ACTIVE COMPARATOR

Clinically established diagnosis of dilated, hypertrophic or arrhythmogenic right ventricular cardiomyopathy Adding T1 mapping sequence to the clinical cardiac magnetic resonance scan Administering Multihance 0.2ml/kg as part of clinical scan Obtaining bloodwork for assessment of hematocrit and collagen biomarkers

Other: Cardiac magnetic resonance sequence T1 mapping

Congenital Heart Disease

ACTIVE COMPARATOR

Diagnosis of Transposition of the great arteries after arterial switch operation, repaired Tetralogy of Fallot, patients after single ventricle palliation at the Fontan stage, native and repaired Aortic Coarctation Adding T1 mapping sequence to the clinical cardiac magnetic resonance scan Administering Multihance 0.2ml/kg as part of clinical scan Obtaining bloodwork for assessment of hematocrit and collagen biomarkers

Other: Cardiac magnetic resonance sequence T1 mapping

Controls

ACTIVE COMPARATOR

Patients undergoing a non-cardiac MR investigation (musculoskeletal / abdomen / brain) without a history of cardiac disease Adding limited cardiac sequence to the clinical magnetic resonance scan including T1 mapping Administering Multihance 0.2ml/kg as part of clinical scan Obtaining bloodwork for assessment of hematocrit and collagen biomarkers

Other: Cardiac magnetic resonance sequence T1 mapping

Interventions

Cardiac magnetic resonance sequence T1 mapping OTHER

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

Cardiomyopathy; Congenital Heart Disease; Controls

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients / guardians capable of giving informed consent
• Informed written consent / assent by the parents / legal guardians and patients where applicable
• Ability to undergo a MRI examination without anaesthesia. Children \> 6 years are typically able to cooperate sufficiently.
• Control Patients: Patients undergoing a non-cardiac MR investigation (musculoskeletal / abdomen / brain) including gadolinium without a history of cardiac disease

You may not qualify if:

• General contraindications for a MRI examination such as non-MRI compatible metallic implants, claustrophobia.
• No contrast required for the clinical portion of the MRI
• Patients who require anaesthesia for MRI (typically \< 6 years of age)
• Known renal failure or previous allergic reaction to gadolinium containing contrast agent
• Control subjects: history of cardiac problems, e.g. rhythm disorders, former myocarditis, active myositis or other inflammatory conditions except suspected or confirmed inflammatory bowel disease such as Crohn's disease or ulcerative colitis
• Known pregnancy or breast feeding

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Lars Grosse-Wortmann, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: January 30, 2015
• Study Start: February 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

CA (1)