Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000875909
Ethics application status
Not yet submitted
Date submitted
31/07/2011
Date registered
17/08/2011
Date last updated
17/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Phospholipase A2 inflammatory marker release during elective coronary stenting
Scientific title
The release of phospholipase A2 inflammatory markers during percutaneous coronary intervention in patients with significant coronary stenosis and their relationship with angiographic, biochemical and epidemiologic factors.
Secondary ID [1] 262838 0
SCGH 2011-082
Universal Trial Number (UTN)
U1111-1121-2268
Trial acronym
PLAPCI biomarker study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 265813 0
Condition category
Condition code
Cardiovascular 265964 265964 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The amount of PLA2 enzymes prior to and after elective coronary stenting (measured from a blood sample approximately 30 minutes apart)
Intervention code [1] 264550 0
Not applicable
Comparator / control treatment
Phospholipase A2 release will be measured in 50 patients prior to and after coronary angiography but who do not undergo any intervention
Control group
Active

Outcomes
Primary outcome [1] 266771 0
To quantify S-PLA2 and LP-PLA2 mass and activity levels immediately prior to and following elective coronary intervention and to determine if a significant change has occurred and demonstrate a positive correlation of baseline and post PCI change in PLA2 levels with patient, biochemical, angiographic and invasive imaging characteristics to identify the best candidate assay. PLA2 levels will be assessed using an ELISA assay on blood taken from the patient prior to and after coronary stenting (approximately 30 minutes apart).
Timepoint [1] 266771 0
Prior to and after coronary stenting (approx 30 mins apart - 2 samples taken only)
Primary outcome [2] 269343 0
To demonstrate that trauma caused during elective PCI and not the angiographic process is responsible for PLA2 release. This will be determined by comparing the blood levels of PLA2 after stenting in 200 patients undergoing coronary stenting, compared with PLA2 blood levels in 50 patients after coronary angiography only.
Timepoint [2] 269343 0
At baseline prior to and after coronary stenting (approx 30 mins apart), or for the comparator group, prior to and after coronary angiography (approx 30 mins apart)
Secondary outcome [1] 279416 0
nil
Timepoint [1] 279416 0
nil

Eligibility
Key inclusion criteria
Patients undergoing elective percutaneous coronary intervention
aged 18 to 85 years.
For the comparator group patients included will be aged 18 to 85 and undergoing elective coronary angiography only.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Myocardial ischaemic event <14 days prior to participation
Change in HMG-CoA reductase inhibitor(statin) in last 30 days
Current acute or chronic inflammatory condition

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267565 0
Hospital
Name [1] 267565 0
Research Advisory Council Grant, Sir Charles Gairdner Hospital
Country [1] 267565 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue
Nedlands 6009
WA
Country
Australia
Secondary sponsor category [1] 264126 0
None
Name [1] 264126 0
Address [1] 264126 0
Country [1] 264126 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 269526 0
Ethics committee address [1] 269526 0
Ethics committee country [1] 269526 0
Date submitted for ethics approval [1] 269526 0
10/08/2011
Approval date [1] 269526 0
Ethics approval number [1] 269526 0
2011-082

Summary
Brief summary
The aim of this study is to measure the release of PLA2 enzymes during elective coronary stenting in patients with coronary artery disease and to compare this release with known characteristics of the patient and their current treatment.
Trial website
nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32585 0
Address 32585 0
Country 32585 0
Phone 32585 0
Fax 32585 0
Email 32585 0
Contact person for public queries
Name 15832 0
Dr Chris Judkins
Address 15832 0
Cardiovascular Medicine
4th floor, G block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
WA
Country 15832 0
Australia
Phone 15832 0
+61(0) 414468332
Fax 15832 0
Email 15832 0
[email protected]
Contact person for scientific queries
Name 6760 0
Dr Chris Judkins
Address 6760 0
Cardiovascular Medicine
4th floor, G block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
WA
Country 6760 0
Australia
Phone 6760 0
+61 (0) 414468332
Fax 6760 0
Email 6760 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.