Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000354482
Ethics application status
Approved
Date submitted
14/06/2007
Date registered
3/07/2007
Date last updated
6/04/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Adult stem cells and G-CSF in chronic ischaemic heart disease
Scientific title
Granulocyte colony stimulating factor (G-CSF) in Angina patients with Ischaemic heart disease to stimulate Neovascularisation.
Universal Trial Number (UTN)
Trial acronym
GAIN II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic ischaemic heart disease 1911 0
Condition category
Condition code
Cardiovascular 2002 2002 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 1826 0
Treatment: Drugs
Comparator / control treatment
Placebo
Saline
Subcutaneous
Three 5 day cycles (each cycle fortnight apart)
Control group
Placebo

Outcomes
Primary outcome [1] 2825 0
Number of abnormal perfusion segments on adenosine cardiac magnetic resonance imaging
Timepoint [1] 2825 0
At 6 months.
Secondary outcome [1] 4768 0
1. Myocardial perfusion ratio index on MRI.
Timepoint [1] 4768 0
At 3 months and 6 months
Secondary outcome [2] 4769 0
2. Angina and quality of life measures (Seattle angina questionnaire)
Timepoint [2] 4769 0
At 3 months and 6 months
Secondary outcome [3] 4770 0
3. Duke treadmill score
Timepoint [3] 4770 0
At 3 months and 6 months

Eligibility
Key inclusion criteria
1. Canadian class III/IV angina2. Angiographically proven coronary artery disease3. Demonstrable reversible ischaemia on adenosine stress cardiac MRI.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Subjects and the doctors in direct contact with subjects will be blinded.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 604 0
Australia wide

Funding & Sponsors
Funding source category [1] 2143 0
Other
Name [1] 2143 0
RT Hall Estate
Country [1] 2143 0
Australia
Funding source category [2] 2144 0
Commercial sector/Industry
Name [2] 2144 0
MBF
Country [2] 2144 0
Australia
Funding source category [3] 2145 0
Charities/Societies/Foundations
Name [3] 2145 0
Johnson Family Foundation
Country [3] 2145 0
Australia
Funding source category [4] 3174 0
Hospital
Name [4] 3174 0
St Vincent's Clinic Foundation
Country [4] 3174 0
Australia
Funding source category [5] 3175 0
Other
Name [5] 3175 0
Cardiovascular Lipid Research Grants (Pfizer Australia)
Country [5] 3175 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
390 Victoria St, Darlinghurst, Sydney 2010
Country
Australia
Secondary sponsor category [1] 1947 0
Other
Name [1] 1947 0
The Victor Chang Cardiac Research Institute
Address [1] 1947 0
384 Victoria St, Darlinghurst, Sydney
Country [1] 1947 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3941 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 3941 0
Ethics committee country [1] 3941 0
Australia
Date submitted for ethics approval [1] 3941 0
Approval date [1] 3941 0
07/06/2006
Ethics approval number [1] 3941 0
H07/046

Summary
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).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27640 0
Address 27640 0
Country 27640 0
Phone 27640 0
Fax 27640 0
Email 27640 0
Contact person for public queries
Name 11015 0
Sharon Chih
Address 11015 0
The Victor Chang Cardiac Research Institute
384 Victoria St
Darlinghurst NSW 2010
Country 11015 0
Australia
Phone 11015 0
+61 2 82958500
Fax 11015 0
Email 11015 0
[email protected]
Contact person for scientific queries
Name 1943 0
Sharon Chih
Address 1943 0
The Victor Chang Cardiac Research Institute
384 Victoria St
Darlinghurst NSW 2010
Country 1943 0
Australia
Phone 1943 0
+61 2 82958500
Fax 1943 0
Email 1943 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.