Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001312437
Ethics application status
Approved
Date submitted
2/09/2016
Date registered
19/09/2016
Date last updated
19/11/2019
Date data sharing statement initially provided
19/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Plasma lipoproteins in coronary artery disease.
Scientific title
Redox signaling, Beta 2 Glycoprotein 1 and plasma lipoproteins in coronary artery disease.
Secondary ID [1] 290078 0
None
Universal Trial Number (UTN)
U1111-1187-1898
Trial acronym
PLACARD
(PLasmA lipoproteins in Coronary ArteRy Disease)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 300155 0
Association of plasrma lipoproteins in atherosclerotic and atherothrombotic coronary artery disease. 300156 0
Condition category
Condition code
Cardiovascular 300039 300039 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
1. To investigate the association between post translational forms of circulating plasma lipoproteins, beta-2-glycoprotein I, HDL and ApoB100, and atherosclerotic coronary disease.

2. To investigate the association between post translational forms of circulating plasma lipoproteins, beta-2-glycoprotein I, HDL and ApoB100, and clinical presentation with atherothrombotic acute coronary disease.

3. To investigate the association between post translational forms of circulating plasma lipoproteins, beta-2-glycoprotein I, HDL and ApoB100, and complications after percutaneous coronary intervention and late graft failure after CABG.

The patients having angiography or CT angiography, a 15 ml blood sample shall be collected at the time of procedure. Out of this group, the patients who did not have ACS and have stent implantation shall have second blood sample 3 hours post procedure.
The patients presenting with ST elevation myocardial infarction will have collection of only one blood sample 24 hours after the stent implantation.

Clinical follow up shall be performed by phone interview at 30 days 12 months and at 2 years.
Intervention code [1] 295814 0
Diagnosis / Prognosis
Comparator / control treatment
Plasma lipoproteins levels in patients with no coronary artery disease.
Control group
Active

Outcomes
Primary outcome [1] 299516 0
Correlation of beta-2-glycoprotein I, HDL and APOB100 on serum ELISA with the extent of coronary artery disease.
This shall be assessed both as multiple separate outcomes and composite outcomes.
The extent of coronary artery disease shall be measured with SYNTAX Score.
Timepoint [1] 299516 0
Cross-sectional at the time of angiography.
Primary outcome [2] 299557 0
Correlation of beta-2-glycoprotein I, HDL and APOB100 on serum ELISA with clinical presentation.
Again, this shall be assessed both as multiple separate outcomes and composite outcomes.
Clinical presentation is assessed by history taking, examination, ECG and troponin elevation.
Timepoint [2] 299557 0
Cross-sectional at the time of angiography.
Secondary outcome [1] 327410 0
Major adverse cardiac events (MACE) at 1 month, 12 months and 2 years follow-up. MACE is defined as death, stroke, myocardial infarction, admission with heart failure and requirement for coronary revascularization.
Patients shall be contacted for a phone interview.
Timepoint [1] 327410 0
1 month, 12 months and 2 years post CT coronary angiography or invasive coronary angiography.
Secondary outcome [2] 327505 0
Correlation of beta-2-glycoprotein I, HDL, APOB100 on serum ELISA and late graft failure after CABG.
This shall be assessed both as multiple separate outcomes and composite outcomes.
Graft failure shall be assessed by coronary angiography and the review of medical records.
Timepoint [2] 327505 0
Cross-sectional at the time of angiography.
Secondary outcome [3] 327506 0
Correlation of beta-2-glycoprotein I, HDL, APOB100 on serum ELISA and complication post percutaneous coronary intervention.
Complications shall be assessed from the cardiac cathlab database and the review of medical records.
Complications shall be assessed by the review of the medical records, ECGs and blood tests.
Timepoint [3] 327506 0
Cross-sectional at the time of angiography with repeat blood test 3 hours after stent implantation.

Eligibility
Key inclusion criteria
All patients recommended to have CT coronary angiography or coronary angiography will be recruited.
Pre specified subgroup analysis will be performed based upon angiographic findings and clinical presentation.
Willing to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Severe valvular disease.
2. Thrombolysis in last one week
3. Previously enrolled in this study
4. Active sepsis
5. Nephrotic syndrome
6. End stage renal failure on dialysis
7. Severe liver disease (Child-Pugh C)
8. Current pregnancy
9. Previously documented Antiphospholipid Antibody Syndrome
10. Active malignancy
11. Cerebrovascular accident in the last 3 months

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
In the stable group the total number remains the same 552. The ACS patients group is recalculated and includes 143 while the CABG pilot study number is not changed and remains 100 patients.
This makes the total study group of 795.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
19/09/2016
Actual
19/09/2016
Date of last participant enrolment
Anticipated
18/09/2018
Actual
29/05/2018
Date of last data collection
Anticipated
18/09/2020
Actual
Sample size
Target
795
Accrual to date
Final
795
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6612 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 14219 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 294448 0
Hospital
Name [1] 294448 0
St George Hospital
Country [1] 294448 0
Australia
Primary sponsor type
Hospital
Name
St George Hospital
Address
Gray St, Kogarah 2217
NSW
Country
Australia
Secondary sponsor category [1] 293302 0
None
Name [1] 293302 0
Address [1] 293302 0
Country [1] 293302 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295878 0
Human Research Ethics Committee, South Eastern Sydney Local Health District
Ethics committee address [1] 295878 0
Ethics committee country [1] 295878 0
Australia
Date submitted for ethics approval [1] 295878 0
18/05/2016
Approval date [1] 295878 0
25/08/2016
Ethics approval number [1] 295878 0
16/174 (HREC/16/POWH/362)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68790 0
Dr James Weaver
Address 68790 0
St George Hospital
Cardiology Department, Level 1
Clinical Services Building
Gray St. Kogarah, 2217
NSW
Country 68790 0
Australia
Phone 68790 0
+61 2 9113 3165
Fax 68790 0
+61 2 9113 1826
Email 68790 0
[email protected]
Contact person for public queries
Name 68791 0
James Weaver
Address 68791 0
St George Hospital
Cardiology Department, Level 1
Clinical Services Building
Gray St. Kogarah, 2217
NSW
Country 68791 0
Australia
Phone 68791 0
+61 2 9113 3165
Fax 68791 0
+61 2 9113 1826
Email 68791 0
[email protected]
Contact person for scientific queries
Name 68792 0
James Weaver
Address 68792 0
St George Hospital
Cardiology Department, Level 1
Clinical Services Building
Gray St. Kogarah, 2217
NSW
Country 68792 0
Australia
Phone 68792 0
+61 2 9113 3165
Fax 68792 0
+61 2 9113 1826
Email 68792 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.