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Trial registered on ANZCTR


Registration number
ACTRN12608000308392
Ethics application status
Approved
Date submitted
20/06/2008
Date registered
30/06/2008
Date last updated
27/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Peri-procedural Iron Chelation on Myocardial Infarct Size and Oxidative Stress in ST-elevation Myocardial Infarction
Scientific title
Effects of Peri-procedural Iron Chelation on Myocardial Infarct Size and Oxidative Stress in ST-elevation Myocardial Infarction
Secondary ID [1] 586 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary heart disease 3288 0
Condition category
Condition code
Cardiovascular 3450 3450 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous desferrioxamine; 500mg IV bolus over 10 minutes followed by 50mg/kg infusion over 12 hours
Intervention code [1] 3025 0
Treatment: Drugs
Comparator / control treatment
Placebo; 10ml of Water for Injection as IV bolus for 10 minutes followed by 100ml normal saline over 12 hours
Control group
Placebo

Outcomes
Primary outcome [1] 4345 0
Myocardial infarct size by cardiac magnetic resonance imaging (CMRI)
Timepoint [1] 4345 0
Time point: During initial hospital admission and at 12 weeks post myocardial infarction
Primary outcome [2] 4346 0
Myocardial infarct size by cardiac biomarkers (creatine kinase (CK; area under the curve over 72 hours), cardiac troponin I (cTnI), and ST segment resolution) by blood samples
Timepoint [2] 4346 0
During initial hospital admission
Primary outcome [3] 4390 0
Myocardial infarct size by transthoracic echocardiography
Timepoint [3] 4390 0
During initial hospital admission
Secondary outcome [1] 7318 0
Plasma markers of oxidative stress (F2-isoprostanes), C-reactive protein (CRP), and iron regulation (all parameters of the iron study including serum iron, ferritin, transferrin, total iron binding capacity [TIBC], soluble transferrin receptor concentration) by blood sample analysis
Timepoint [1] 7318 0
During initial hospital admission and at 12 weeks post myocardial infarction
Secondary outcome [2] 7319 0
Myocardial iron loading by CMRI T2* (a specialised CMRI sequence assessing iron loading and content in the myocardium)
Timepoint [2] 7319 0
During initial hospital admission at 12 weeks post myocardial infarction
Secondary outcome [3] 7320 0
Pre-specified analysis of myocardial infarct size stratified according to time of presentation e.g. in those presenting <3hours compared those those presenting >3hours, and according to Thrombolysis in Myocardial Infarction (TIMI) flow grade and vessel patency
Timepoint [3] 7320 0
During initial hospital admission

Eligibility
Key inclusion criteria
Suspected ST-segment Elevation Myocardial Infarction (STEMI) < 6 hours duration (from symptom onset) defined by detection of rise and/or fall of cardiac biomarkers (troponin and CK) with at least one value above the 99th percentile of the upper reference limit together with evidence of ischemia with at least one of the following:
- Symptoms of ischemia
- Electrocardiographic (ECG) changes of new ischemia (new ST-T elevation or new left bundle branch block [LBBB]) and/or development of new pathological Q waves in the ECG
- New ST elevation at the J point = 0.2 mV in men or = 0.15 mV in women in V2-V3; and/or = 0.1 mV in other leads in both genders
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Permanent pacemaker, implantable cardiac defibrillator, or other metallic prosthesis (ineligible for CMRI)
2) Suspected previous myocardial infarction in the same coronary artery territory as the current STEMI
3) Rescue angioplasty post-thrombolytics
4) Cardiogenic shock (systolic blood pressure <90mmHg whether or not inotropic support is required)
5) Currently pregnant
6) Known malignancy
7) Known infection
8) Current iron supplementation or known iron deficient state
9) Renal failure (estimated glomerular filtration rate less than or equal to 30ml/min, defined by the Cockroft-Gault formula
10) Thrombocytopenia (platelets <50)
11) Neutropenia
12) Known hypersensitivity to desferrioxamine
13) Unwilling to consent
14) Non-English speaking

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment performed by
-sealed opaque envelopes
-central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation performed by
-simple randomisation by using a randomisation table created by computer software (i.e. computerised sequence generation)
-permuted block randomisation

Allocation stratification will be by
-myocardial infarct territory (i.e. anterior infarcts vs. non-anterior infarcts)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3498 0
Government body
Name [1] 3498 0
NHMRC
Address [1] 3498 0
Level 5
20 Allara Street
Canberra
ACT 2601
Country [1] 3498 0
Australia
Primary sponsor type
Hospital
Name
The Alfred Hospital
Address
Heart Centre
The Alfred Hospital
3rd Floor, W.S. Philip Block
Commercial Road, Melbourne 3004,
Victoria, Australia
Country
Australia
Secondary sponsor category [1] 3141 0
None
Name [1] 3141 0
Address [1] 3141 0
Country [1] 3141 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5535 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 5535 0
The Alfred Hospital
Commercial Road
Melbourne
Victoria 3004
Ethics committee country [1] 5535 0
Australia
Date submitted for ethics approval [1] 5535 0
Approval date [1] 5535 0
14/05/2008
Ethics approval number [1] 5535 0
Project 57/08

Summary
Brief summary
The aim of the project is to test whether giving a medication called desferrioxamine (commonly used in patients with iron-overload conditions such as beta-thalassaemia) in the setting of a heart attack can reduce the amount of heart muscle injury. We hypothesise that that this medication may therefore improve the outlook for people following heart attacks. This medication has been used safely in adults and children with beta thalassaemia at even higher doses. This drug has been shown in experimental, animal and a few human studies to reduce the “oxidative stress” (that is, acts as an “antioxidant”) of tissues which have had their blood supply compromised (as in the case of a heart attack). Some of the animal studies have also shown that it reduces the size of heart attacks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28682 0
Address 28682 0
Country 28682 0
Phone 28682 0
Fax 28682 0
Email 28682 0
Contact person for public queries
Name 11839 0
Dr William Chan
Address 11839 0
Heart Centre
The Alfred Hospital, 3rd Floor, W.S. Philip Block
Commercial Road, Melbourne 3004, Victoria, Australia
Country 11839 0
Australia
Phone 11839 0
61-3-9076.3263; Mobile: 0401675512
Fax 11839 0
61-3-9376.8438
Email 11839 0
w.chan2@alfred.org.au
Contact person for scientific queries
Name 2767 0
Dr William Chan
Address 2767 0
Heart Centre
The Alfred Hospital, 3rd Floor, W.S. Philip Block
Commercial Road, Melbourne 3004, Victoria, Australia
Country 2767 0
Australia
Phone 2767 0
61-3-9076.3263; Mobile: 0401675512
Fax 2767 0
61-3-9376.8438
Email 2767 0
w.chan2@alfred.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary