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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
Request Number:
082089
ACTR Number:
ACTRN12607000354482
Trial Status:
Registered
Date Submitted:
14/06/2007
Date Registered:
3/07/2007
Page 1
Public title:
Adult stem cells and G-CSF in chronic ischaemic heart disease
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Reason:
ANZCTR registration title:
Granulocyte colony stimulating factor (G-CSF) in Angina patients with Ischaemic heart disease to stimulate Neovascularisation.
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Secondary ID:
UTN:
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Trial acronym:
GAIN II
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Page 2
Health condition(s) or problem(s) studied:
Chronic ischaemic heart disease
Condition category:
Condition code:
Cardiovascular
Coronary heart disease
Page 3
Description of intervention(s) / exposure:
Granulocyte colony stimulating factor
Subcutaneous
Commenced at 4.5 mcg/kg/d
Three 5 day cycles (each cycle fortnight apart)
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Reason:
Intervention code:
Treatment: drugs
Comparator / control treatment:
Placebo Saline Subcutaneous Three 5 day cycles (each cycle fortnight apart)
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Control group:
Placebo
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Reason:
Page 4
Primary outcome:
Number of abnormal perfusion segments on adenosine cardiac magnetic resonance imaging
Timepoint:
At 6 months.
Secondary outcome 1:
1. Myocardial perfusion ratio index on MRI.
Timepoint:
At 3 months and 6 months
Secondary outcome 2:
2. Angina and quality of life measures (Seattle angina questionnaire)
Timepoint:
At 3 months and 6 months
Secondary outcome 3:
3. Duke treadmill score
Timepoint:
At 3 months and 6 months
Page 5
Key inclusion criteria:
1. Canadian class III/IV angina2. Angiographically proven coronary artery disease3. Demonstrable reversible ischaemia on adenosine stress cardiac MRI.
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Minimum Age:
18
Years
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Maximum Age:
Not stated
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Gender:
Both males and females
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Healthy volunteers?
No
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Key exclusion criteria:
1. MI < 3 months2. Unstable angina3. Uncontrolled heart failure. 4. EF < 20%5. Significant (>50%) left main or left main equivalent disease6. Advanced coronary artery bypass graft disease.7. Factors preventing MRI including permanent pacemaker, implantable defibrillator, neurostimulator, severe claustrophobia8. Contraindications to adenosine including high degree heart block, severe bronchospasm.9. Proliferative retinopathy
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Page 6
Study type:
Interventional
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Purpose of the study:
Treatment
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Allocation to intervention:
Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
Patients will be referred by their primary cardiologist. Once enrolled, subjects will be randomised to either G-CSF followed by placebo or Placebo followed by G-CSF therapy. This allocation will be concealed from both patient and the investigator responsible for patient enrolment and subsequent patient reviews. The allocation schedule will be held by Pharmacy.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
Simple randomisation by using a randomisation table
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Masking / blinding:
Blinded (masking used)
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Who is/are masked/blinded:
The people receiving the treatment/s
The people administering the treatment/s
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Assignment:
Crossover
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Other design features (specify):
Subjects and the doctors in direct contact with subjects will be blinded.
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Type of endpoint(s):
Efficacy
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Page 7
Phase
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Anticipated or actual date of first participant enrolement:
18/06/2007
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Target sample size:
20
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Recruitment status:
Completed
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Page 8
Funding source 1:
Other
Name:
RT Hall Estate
Address:
Nexia Court & Company Level 29 Australia Square 264 George St, Sydney
Country:
Australia
Funding source 2:
Commercial sector/Industry
Name:
MBF
Address:
50 Bridge Street, Sydney NSW, 2000
Country:
Australia
Funding source 3:
Charities/Societies/Foundations
Name:
Johnson Family Foundation
Address:
Perpetual Foundation GPO Box 4172, Sydney NSW
Country:
Australia
Funding source 4:
Hospital
Name:
St Vincent's Clinic Foundation
Address:
Victoria St, Darlinghurst, Sydney
Country:
Australia
Funding source 5:
Other
Name:
Cardiovascular Lipid Research Grants (Pfizer Australia)
Address:
PO Box 57, West Ryde
Country:
Australia
Primary sponsor:
Hospital
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Reason:
Name:
St Vincent's Hospital
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Address:
390 Victoria St, Darlinghurst, Sydney 2010
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Reason:
Country:
Australia
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Secondary sponsor:
Other
Name:
The Victor Chang Cardiac Research Institute
Address:
384 Victoria St, Darlinghurst, Sydney
Country:
Australia
Other collaborator:
Page 9
Has the study received approval from at least one ethics committee?
Yes
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Reason:
Ethics Committee name:
St Vincent's Hospital Human Research Ethics Committee
Address:
Country:
Australia
Date of approval:
7/06/2006
HREC Number:
H07/046
Countries of recruitment:
Australia
Postcode:
Australia wide
Brief summary:
Angina is a medical term used to describe pain (usually felt in the chest) due to coronary artery disease causing reduced blood flow to the heart. We are investigating the use of G-CSF to treat chronic angina in patients who have failed standard treatment with medications and or coronary stenting/coronary artery bypass surgery. G-CSF is a man made version of a naturally occuring hormone. There is experimental evidence that G-CSF can stimulate the formation of new blood vessels in the heart and protect heart muscle cells. Through these effects, we hypothesise that patients will derive improvements in blood flow to the heart and hence angina symptoms. We will be measuring the effects of G-CSF on blood flow to the heart with cardiac magnetic resonance imaging (MRI scan).
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Page 10
Contact person for public queries
Name:
Sharon Chih
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Address:
The Victor Chang Cardiac Research Institute 384 Victoria St Darlinghurst NSW 2010
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Country:
Australia
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Tel:
+61 2 82958500
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Fax:
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Email:
s.chih@victorchang.edu.au
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Contact person for scientific queries
Name:
Sharon Chih
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Address:
The Victor Chang Cardiac Research Institute 384 Victoria St Darlinghurst NSW 2010
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Country:
Australia
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+61 2 82958500
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Email:
s.chih@victorchang.edu.au
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