Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000437369
Ethics application status
Approved
Date submitted
13/08/2008
Date registered
29/08/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Applying Novel Biomarkers to Assess Cardiac Risk in Patients Undergoing Major Vascular Surgery: Defining Iron, Oxidative Stress, Inflammation, Matrix Metalloproteinases, Coagulation Factors, Lipidomics, Endothelial Dysfunction and Other Relevant Markers as Novel Risk Predictors
Scientific title
Applying Novel Biomarkers to Assess Cardiac Risk in Patients Undergoing Major Vascular Surgery: Defining Iron, Oxidative Stress, Inflammation, Matrix Metalloproteinases, Coagulation Factors, Lipidomics, Endothelial Dysfunction and Other Relevant Markers as Novel Risk Predictors
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary heart disease 3555 0
Peripheral vascular disease 3556 0
Condition category
Condition code
Cardiovascular 3710 3710 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
Obervational study. The study aims to observe whether a certain risk markers in blood correlate with the occurrence of cardiovascular events (CVE) following major vascular surgery. The intended duration of observation is at least 30 days following vascular surgery and up to 1 year per patient.
Intervention code [1] 3267 0
Not applicable
Comparator / control treatment
Not applicable - Observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4614 0
Peri-operative cardiovascular event (CVE) defined by a composite endpoint of peri-operative myocardial infarction (PMI) either ST-segment elevation myocardial infarction (STEMI) or non-ST segment elevation myocardial infarction (NSTEMI); stroke; and/or cardiac death. It is anticipated that almost all PMIs will be of the NSTEMI type.
Timepoint [1] 4614 0
30 days post vascular surgery
Secondary outcome [1] 7783 0
PMI
Timepoint [1] 7783 0
30 days post vascular surgery
Secondary outcome [2] 7784 0
Stroke
Timepoint [2] 7784 0
30 days post vascular surgery
Secondary outcome [3] 7785 0
Cardiac death
Timepoint [3] 7785 0
30 days post vascular surgery

Eligibility
Key inclusion criteria
Patients >18 years of age. Vascular surgery either urgent, elective or semi-elective including: open repair of abdominal aortic aneurysm (AAA); supra-inguinal or infra-inguinal bypass or reconstructive surgery (e.g. aorto-bifemoral grafting).
Minimum age
18 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unwilling to consent. Myocardial infarction <6weeks. Percutaneous coronary intervention with bare stent <6weeks; or drug-eluting stent <12 months.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3733 0
Government body
Name [1] 3733 0
National Health and Medical Research Council (NHMRC)
Country [1] 3733 0
Australia
Primary sponsor type
Hospital
Name
The Alfred Hospital
Address
Heart Center
The Alfred Hospital,
3rd Floor, W.S. Philip Block
Commercial Road, Melbourne 3004,
Victoria, Australia
Country
Australia
Secondary sponsor category [1] 3349 0
None
Name [1] 3349 0
Address [1] 3349 0
Country [1] 3349 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5785 0
The Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 5785 0
The Alfred Hospital
Commercial Road
Melbourne
Victoria 3004
Ethics committee country [1] 5785 0
Australia
Date submitted for ethics approval [1] 5785 0
Approval date [1] 5785 0
17/06/2008
Ethics approval number [1] 5785 0
Project 125/08

Summary
Brief summary
The aim of the project is to investigate the usefulness of novel markers (‘biomarkers’) in predicting the risk of experiencing a CVE (defined as a composite of STEMI or NSTEMI, stroke, or death) during or after vascular surgery in patients with severe peripheral vascular disease (PVD) who require surgical correction or bypass. The risk of a CVE in this group of patients is typically about 20-25%. The prevalence of coronary artery disease in this select group of participants approaches 50% and increases with age. Current risk assessment methods, although useful, may not necessarily detect all at-risk patients, especially those without pre-existing symptoms of ischaemic heart disease such as angina or previous myocardial infarcts. This study will assess if newer methods can help detect at-risk patients who may not have symptoms of heart disease but who are still at risk of developing a CVE peri-operatively.

Examples of novel biomarkers measured preoperatively include endothelial function testing by fingertip arterial tonometry, iron studies, myeloperoxidase, matrix metalloproteinase, and lipidomic profiling.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28842 0
Address 28842 0
Country 28842 0
Phone 28842 0
Fax 28842 0
Email 28842 0
Contact person for public queries
Name 11999 0
Dr William Chan
Address 11999 0
Heart Centre
The Alfred Hospital, 3rd Floor, W.S. Philip Block
Commercial Road, Melbourne 3004, Victoria
Country 11999 0
Australia
Phone 11999 0
61-3-9076.3263
Fax 11999 0
61-3-9376.8438
Email 11999 0
[email protected]
Contact person for scientific queries
Name 2927 0
Dr William Chan
Address 2927 0
Heart Centre
The Alfred Hospital, 3rd Floor, W.S. Philip Block
Commercial Road, Melbourne 3004, Victoria
Country 2927 0
Australia
Phone 2927 0
61-3-9076.3263
Fax 2927 0
61-3-9376.8438
Email 2927 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.