Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000713897
Ethics application status
Approved
Date submitted
22/02/2021
Date registered
8/06/2021
Date last updated
8/06/2021
Date data sharing statement initially provided
8/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Lipoprotein (a) as a risk factor for restenosis in patients with aortoiliac disease undergoing endovascular management
Scientific title
Lipoprotein (a) as a risk factor for restenosis in patients with aortoiliac disease undergoing endovascular management
Secondary ID [1] 303524 0
None
Universal Trial Number (UTN)
U1111-1265-2213
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortoiliac occlusive disease 320853 0
Peripheral arterial disease 320856 0
Stenosis 320857 0
Condition category
Condition code
Cardiovascular 318676 318676 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an interventional, prospective study to assess the relationship between serum Lp(a) concentration and the development of restenosis in 60 patients with aortoiliac PAD undergoing endovascular therapy up to 12 months post endovascular therapy. The patient's procedure will be conducted as per usual standard of care. Blood sample will be collected at baseline, post-procedure and 1-, 6- and 12-months post-procedure.
Intervention code [1] 319807 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326618 0
Lp (a) measurement using blood sample
Timepoint [1] 326618 0
30-days post-procedure
Primary outcome [2] 327617 0
Stent patency using duplex ultrasound
Timepoint [2] 327617 0
30-days post procedure
Secondary outcome [1] 392153 0
• Primary patency at 6 months post index procedure using duplex ultrasound
Timepoint [1] 392153 0
6-months post procedure
Secondary outcome [2] 395755 0
Primary patency at 12 months post procedure using duplex ultrasound
Timepoint [2] 395755 0
12 months post procedure
Secondary outcome [3] 395757 0
Secondary patency using duplex ultrasound
Timepoint [3] 395757 0
12 months post procedure
Secondary outcome [4] 396295 0
Binary restenosis using duplex ultrasound
Timepoint [4] 396295 0
30 days post index procedure
Secondary outcome [5] 396296 0
Rate of Target lesion revascularisation determined from hospital records
Timepoint [5] 396296 0
30 days post-index procedure
Secondary outcome [6] 396297 0
CRP, FBC and lipid profile (HDL, LDL, Triglycerides, apoprotein B) levels from blood sample
Timepoint [6] 396297 0
30 days post index procedure

Eligibility
Key inclusion criteria
1. Patients greater than or equal to 18 years of age
2. The participant has provided written informed consent
3. Evidence of TASC B, C or D lesions (TASC II classification)
4. Patients undergoing endovascular therapy for aortoiliac occlusive disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients less than 18 years of age
2. Pregnant women or women of childbearing potential who are not using an effective method of contraception
3. Uncontrolled hypertension
4. TASC A lesion
5. Patients requiring open procedure
6. Extensive common femoral artery disease or multiple groin procedures
7. Contraindication to antiplatelet use
8. Occluded superficial and profunda femoral arteries
9. Noncompliance with protocol requirements
10. Previous or planned surgical or interventional procedure within 14 days before or 30 days after the index procedure

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Efficacy
Statistical methods / analysis
The sample size was determined by aiming to have adequate power to test out hypothesis that Lp(a) greater than or equal to 50 mg/dL was associated with increased rates of restenosis. Based on previous studies and publications.

Descriptive statistics will be presented for all the primary and secondary endpoints.

For quantitative variables, the mean values, standard deviation, maximum and minimum, as well as the 95% CI (confidence interval) for the mean will be calculated when relevant.

Kaplan Meier estimates will be performed to measure clinical endpoints including primary patency and binary restenosis.

Cox proportional hazard analyses will be used to assess the association between serum Lp(a) with outcomes of interest, adjusted for other risk factors.

Further analysis will be conducted by stratifying patients into two groups. Group A will have normal baseline Lp(a) levels +/- inflammatory markers; Group B will have high levels of Lp(a) +/- inflammatory markers. In this study, LP(a) levels will be defined as high if serum Lp(a) are greater than or equal to 0.5g/L and as low Lp(a) if less than 0.5g/L.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2021
Actual
Date of last participant enrolment
Anticipated
30/06/2022
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 18807 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 33255 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 307946 0
Hospital
Name [1] 307946 0
Royal Perth Hospital Vascular Department
Country [1] 307946 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Department of Vascular Surgery
Level 6 North Block
Royal Perth Hospital
180 Wellington Street
Perth WA 6000
Country
Australia
Secondary sponsor category [1] 308663 0
None
Name [1] 308663 0
Address [1] 308663 0
Country [1] 308663 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307938 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 307938 0
197 Wellington Street
Perth WA 6000
Ethics committee country [1] 307938 0
Australia
Date submitted for ethics approval [1] 307938 0
17/11/2020
Approval date [1] 307938 0
12/01/2021
Ethics approval number [1] 307938 0
RGS4460

Summary
Brief summary
Peripheral arterial diseases (PADs) are a collection of chronic occlusive conditions affecting adults, which predominately occur due to atherosclerosis and affects approximately 15% of the Australian population. Lipoprotein (a) [Lp(a)] is an emerging risk factor for PAD and atherosclerosis. Multiple studies have demonstrated a causal relationship between elevated Lp(a) and the development of atherosclerotic cardiovascular disease, calcific aortic valve disease and inflammation. The role of Lp(a) in restenosis in PAD is unclear, however Lp(a) is implicated in promoting atherosclerosis progression, thrombosis and inflammation which are all pathological processes thought to be critical in stimulating PAD progression and the need for surgical intervention. The primary aim of this study is to assess the relationship between serum Lp(a) concentration and the development of restenosis in 60 patients with aortoiliac PAD undergoing endovascular therapy up to 12 months post endovascular therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108986 0
A/Prof Patrice Mwipatayi
Address 108986 0
Royal Perth Hospital
Department of Vascular Surgery
Level 6, North Block,
180 Wellington Street
Perth, WA, 6000
Country 108986 0
Australia
Phone 108986 0
+61 8 9224 2191
Fax 108986 0
Email 108986 0
[email protected]
Contact person for public queries
Name 108987 0
A/Prof Patrice Mwipatayi
Address 108987 0
Royal Perth Hospital
Department of Vascular Surgery
Level 6, North Block,
180 Wellington Street
Perth, WA, 6000
Country 108987 0
Australia
Phone 108987 0
+61 8 9224 2191
Fax 108987 0
Email 108987 0
[email protected]
Contact person for scientific queries
Name 108988 0
A/Prof Patrice Mwipatayi
Address 108988 0
Royal Perth Hospital
Department of Vascular Surgery
Level 6, North Block,
180 Wellington Street
Perth, WA, 6000
Country 108988 0
Australia
Phone 108988 0
+61 8 9224 2191
Fax 108988 0
Email 108988 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified individual data including demographic data, blood results and follow up data
When will data be available (start and end dates)?
Data will be available immediately following publication. There is no end date to availability. Data will be available for 5 years after publication and beyond
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator email: [email protected]


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.