MR Imaging of Diffuse Myocardial Fibrosis in Transfusion-Dependent Anemias

NCT02090699 | Completed

• 1 other identifier: RSNA-RR1318
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac failure is the major cause of death in patients with thalassemia and chronic blood transfusion-related iron overload. The treatment of thalassemia has been revolutionized over the past decade with the implementation of cardiac MRI based assessment of iron overload. This has enabled detection of cardiac iron overload prior to symptomatic heart failure and now allows for timely therapy which has resulted in a substantial decrease in mortality. However, currently implemented MR imaging techniques assess for iron content only and not for iron related diffuse fibrosis which play a role in iron related heart failure. Histopathologic studies indicate that patients with iron overload have diffuse interstitial fibrosis. Quantitative MR techniques have shown that patients with various cardiomyopathies demonstrate diffuse myocardial fibrosis and that these changes correlate with changes in cardiac function. The investigators propose that quantitative cardiac MRI for assessment of diffuse myocardial fibrosis can further improve our ability to detect early damage to the myocardium and prevent morbidity and mortality from cardiac iron overload. Detection of fibrosis in patients with thalassemia may allow for earlier identification of cardiomyopathy when compared to other techniques in clinical use including T2\* analysis. Identification of fibrosis could affect patient management as it would allow for tailoring of iron chelation therapy and may lead to better understanding of the disease processes contributing to heart failure and arrhythmia in these patients.

Conditions

Thalassemia Major; Chronic Blood Transfusion Related Iron Overload

Keywords

thalassemia major; chronic blood transfusion related iron overload; magnetic resonance imaging; myocardium; fibrosis

Outcome Measures

Primary Outcomes (1)

• Evidence of diffuse myocardial fibrosis (elevated extracellular volume fraction) confirmed by MRI

  At the time of MRI respective imaging data will be collected to assess the extracellular volume fraction as a marker for diffuse myocardial fibrosis.

  at time of cardiac MR examination for each individual

Secondary Outcomes (1)

• Regional myocardial dysfunction as assessed by global longitudinal strain Echocardiography measurement

  at time of echocardiography examination for each individual

Study Arms (2)

Myocardial Iron Overload

chronic blood transfusion related myocardial iron overload

Healthy Volunteers

age matched healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with transfusion dependent anemias Age-matched healthy subjects

You may qualify if:

• Diagnosis of thalassemia Treatment with iron chelation therapy Referral for cardiac MR assessment of iron overload
• No significant past medical history and no evidence of cardiovascular or metabolic disease.

You may not qualify if:

• Arrhythmia Claustrophobia Pregnancy and potential pregnancy (patient cannot exclude potential pregnancy) History of allergic reaction to Gadolinium based contrast agent (GBCA) Impaired renal function with eGFR \< 30 ml/min/1.73m2 Any general MR contraindication such as pacemaker or defibrillators.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Related Publications (1)

• Hanneman K, Nguyen ET, Thavendiranathan P, Ward R, Greiser A, Jolly MP, Butany J, Yang IY, Sussman MS, Wintersperger BJ. Quantification of Myocardial Extracellular Volume Fraction with Cardiac MR Imaging in Thalassemia Major. Radiology. 2016 Jun;279(3):720-30. doi: 10.1148/radiol.2015150341. Epub 2015 Dec 10.

  PMID: 26653680 DERIVED

MeSH Terms

Conditions

beta-Thalassemia; Fibrosis

Condition Hierarchy (Ancestors)

Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. (MD)

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 18, 2014
• Study Start: July 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 17, 2014

Record last verified: 2014-07

Locations

CA (1)