Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000869976
Ethics application status
Not yet submitted
Date submitted
31/07/2011
Date registered
16/08/2011
Date last updated
16/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A substudy of the PLAPCI trial comparing Phospholipase A2 release with tissue characteristics as determined by invasive ultrasound and infrared imaging of the heart arteries in patients with coronary artery disease undergoing coronary artery stenting.
Scientific title
The release of Phospholipase A2 biomarkers during percutaneous coronary intervention in patients with significant coronary artery disease and the relationship of released biomarkers with optical coherence tomography and intravascular ultrasound tissue characterisation.
Secondary ID [1] 262837 0
SCGH 2011-082
Universal Trial Number (UTN)
U1111-1121-2268
Trial acronym
PLAPCI imaging substudy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 270458 0
Condition category
Condition code
Cardiovascular 270610 270610 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Invasive imaging of the coronary arteries prior to and after elective coronary stenting with optical coherence tomography and intravascular ultrasound. Imaging will take place on two occasions approximately 30 minutes apart and will take 15-20minutes to perform on each occasion.
Intervention code [1] 267093 0
Diagnosis / Prognosis
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269344 0
To test the hypothesis that a greater percentage of coronary lipid core and the presence of thin cap fibro-atheroma as assessed by IVUS and OCT will correlate with greater relative PLA2 release during elective percutaneous coronary intervention and to identify which PLA2 assay shows the greatest correlation
Timepoint [1] 269344 0
prior to and after elective coronary intervention (approx 30mins apart)
Secondary outcome [1] 279417 0
nil
Timepoint [1] 279417 0
nil

Eligibility
Key inclusion criteria
Patients undergoing elective percutaneous coronary intervention
age 18 to 85 years
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 Co-A reductase inhibitor (statin) in the last 30 days
Current acute or chronic inflammatory condition
Coronary vessels unsuitable for invasive imaging, including planned left main stenting

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients enrolled will be assessed with invasive imaging (optical coherence tomography and intravascular ultrasound)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
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
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267566 0
Self funded/Unfunded
Name [1] 267566 0
Country [1] 267566 0
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Ave
Nedlands 6009
WA
Country
Australia
Secondary sponsor category [1] 266605 0
None
Name [1] 266605 0
Address [1] 266605 0
Country [1] 266605 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 269527 0
Ethics committee address [1] 269527 0
Ethics committee country [1] 269527 0
Date submitted for ethics approval [1] 269527 0
10/08/2011
Approval date [1] 269527 0
Ethics approval number [1] 269527 0
2011-082

Summary
Brief summary
The aim of this study is to assess the effect of elective coronary stenting procedures on the release of enzymes (PLA2) found in the wall of the coronary artery, and how this release relates to the characteristics of the artery wall as assessed by novel invasive imaging tools
Trial website
nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32958 0
Address 32958 0
Country 32958 0
Phone 32958 0
Fax 32958 0
Email 32958 0
Contact person for public queries
Name 16205 0
Dr Chris Judkins
Address 16205 0
Cardiovascular Medicine
4th Floor, G Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
WA
Country 16205 0
Australia
Phone 16205 0
+61 (0) 414468332
Fax 16205 0
Email 16205 0
[email protected]
Contact person for scientific queries
Name 7133 0
Dr Chris Judkins
Address 7133 0
Cardiovascular Medicine
4th Floor, G Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
WA
Country 7133 0
Australia
Phone 7133 0
+61 (0) 414468332
Fax 7133 0
Email 7133 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.