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Trial registered on ANZCTR


Registration number
ACTRN12612001100886
Ethics application status
Approved
Date submitted
12/10/2012
Date registered
16/10/2012
Date last updated
16/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using cardiac magnetic resonance imaging to detect early changes in heart muscle that may help predict patients who are at risk of developing toxicity from anthracycline chemotherapy.
Scientific title
Use of myocardial tissue characterization by cardiac magnetic resonance imaging to predict left ventricular dysfunction in patients undergoing anthracycline chemotherapy.
Secondary ID [1] 281389 0
Nil
Universal Trial Number (UTN)
U1111-1135-8024
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anthracycline chemotherapy induced cardiac toxicity 287622 0
Lymphoma 287635 0
Condition category
Condition code
Cardiovascular 287951 287951 0 0
Other cardiovascular diseases
Cancer 287952 287952 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 287969 287969 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Magnetic resonance imaging scan of the heart (60 minutes duration) before chemotherapy, on completion of chemotherapy cycles (~3 months) and at 1 year after commencement of chemotherapy.We will use novel MRI sequences (T1 and T2 mapping) which aim to quantify specific magnetic properties of the heart muscle that related to myocardial edema (seen in inflammation) and fibrosis.
Intervention code [1] 285865 0
Not applicable
Comparator / control treatment
Healthy control group (observational). These subjects will also undergo 3 MRI scans at comparable times to patients (baseline, 3 months and 1 year).
Control group
Active

Outcomes
Primary outcome [1] 288160 0
Myocardial T2 time assessed using cardiac MRI at completion of chemotherapy (3 months) will be compared between those that develop significant LV dysfunction at 12 months (an absolute LVEF decline from baseline >20%, or >10% to below lower limit of normal (55%) or >5% decline below 55%) with those who maintain normal LV function at 12 months (control group). LV function (LVEF) using cardiac MRI.
Timepoint [1] 288160 0
Baseline, 3 and 12 months
Primary outcome [2] 288161 0
The change in magnitude of myocardial fibrosis from baseline to 12 months (change in T1 time) using cardiac MRI will be compared between subjects with and without >10% increase in myocardial T2 signal (assessed by T2 mapping using cardiac MRI) at completion of chemotherapy (3 months).
Timepoint [2] 288161 0
Baseline, 3 and 12 months
Primary outcome [3] 288162 0
The relationship of BNP and troponin (assessed by serum assay) with the results of tissue characterization by cardiac MRI (T2 and T1 mapping) and LV functional parameters including myocardial strain and strain rate (assessed by cardiac MRI and echocardiography).
Timepoint [3] 288162 0
Baseline, 3 and 12 months
Secondary outcome [1] 299537 0
Change in myocardial T2 (oedema), T1 (fibrosis), and early gadolinium enhancement ratio (inflammation) over 12 months will be analyzed using repeated measures ANOVA and compared with change in myocardial strain/strain rate (assessed with 2D-speckle tracking echocardiography), and change in early diastolic tissue velocity (Em) and the E/Em ratio (LV filling pressure).
Timepoint [1] 299537 0
Baseline, 3 and 12 months.
Secondary outcome [2] 299538 0
Contrast and compare levels of circulating fibrocytes and serum markers of collagen turnover between subjects who develop LV dysfunction and those who do not. The correlation between these markers and imaging assessment of myocardial fibrosis assessed by T1 mapping will be investigated.
Timepoint [2] 299538 0
Baseline, 12 months

Eligibility
Key inclusion criteria
Patient referred for anthracycline chemotherapy (i.e. for lymphoma)
Healthy controls
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Acute renal failure or chronic renal failure manifest by GFR<60 ml/kg/1.73m2.
2. Contraindication to MRI scanning.
3. Known hypersensitivity to gadolinium.
4. Atrial fibrillation at baseline.
5. Pregnancy.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286139 0
Charities/Societies/Foundations
Name [1] 286139 0
Cardiac Society of Australia and New Zealand
Country [1] 286139 0
Australia
Primary sponsor type
Individual
Name
Dr James Hare
Address
Baker IDI Heart and Diabetes Institute
Heart Centre, Alfred Hospital, 55 Commercial Road, Melbourne, Victoria, 3004
Country
Australia
Secondary sponsor category [1] 284951 0
Individual
Name [1] 284951 0
Dr Andrew Taylor
Address [1] 284951 0
Baker IDI Heart and Diabetes Institute
Heart Centre, Alfred Hospital, 55 Commercial Road, Melbourne, Victoria, 3004
Country [1] 284951 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288193 0
The Alfred Ethics Commitee
Ethics committee address [1] 288193 0
Office of Ethics and Research Governance,
Alfred Hospital, 55 Commercial Road, Melbourne, Victoria 3004
Ethics committee country [1] 288193 0
Australia
Date submitted for ethics approval [1] 288193 0
Approval date [1] 288193 0
22/09/2011
Ethics approval number [1] 288193 0
1/11/0263

Summary
Brief summary
Aim is to assess whether a novel cardiac magnetic resonance imaging (CMR) technique, T2 mapping, can identify myocardial edema as a marker of myocardial injury and be used as a predictor of cardiac dysfunction in patients undergoing anthracycline chemotherapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34825 0
Address 34825 0
Country 34825 0
Phone 34825 0
Fax 34825 0
Email 34825 0
Contact person for public queries
Name 18072 0
Dr James Hare
Address 18072 0
Heart Centre, Alfred Hospital, 55 Commercial Road, Melbourne, Victoria, 3004
Country 18072 0
Australia
Phone 18072 0
+61390762000
Fax 18072 0
Email 18072 0
[email protected]
Contact person for scientific queries
Name 9000 0
Dr James Hare
Address 9000 0
Heart Centre, Alfred Hospital, 55 Commercial Road, Melbourne, Victoria, 3004
Country 9000 0
Australia
Phone 9000 0
+61390762000
Fax 9000 0
Email 9000 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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