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Trial registered on ANZCTR


Registration number
ACTRN12609000744257
Ethics application status
Approved
Date submitted
25/08/2009
Date registered
26/08/2009
Date last updated
2/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Ankle Brachial Index determination by oscillometric method in general practice
Scientific title
An Observation Study of Ankle Brachial Index Determination (ABI) by Oscillometric Method in Persons with Established Cardiovascular Disease or High Risk in General Practice
Secondary ID [1] 962 0
Nil
Universal Trial Number (UTN)
Trial acronym
ABIDING
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral arterial disease 243591 0
Condition category
Condition code
Cardiovascular 239874 239874 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
ABI by general practice nurses using oscillometric blood pressure device. This involves a blood pressure cuff being placed around each arm and leg in turn and being inflated and deflated automatically. This will take 5 minutes. This will only be done on this one occassion.
Intervention code [1] 241180 0
Not applicable
Comparator / control treatment
ABI by research nurses using mercury blood pressure and Doppler ultrasound devices. This involves a blood pressure cuff being placed around each arm and leg in turn and being inflated and deflated manually while listening with an ultrasound machine. This will be repeated and will take 10 minutes.This will only be done on this one occassion.
Control group
Active

Outcomes
Primary outcome [1] 240665 0
Correlation of ABI defined as the ratio of each lower limb systolic blood pressure to the highest systolic brachial blood pressure recording.
Timepoint [1] 240665 0
At intervention
Secondary outcome [1] 257301 0
(i) Correlation of baseline ABI and incident adverse cardiovascular disease events.
(ii) Change in ABI, body mass index, Edinburgh Claudication score and waist circumference from baseline.
Timepoint [1] 257301 0
At intervention

Eligibility
Key inclusion criteria
Particpants in the REduction in Atherothrombosis for Continued Health (REACH) regisrty. At baseline (participants were enrolled over a four-month period from March to June 2004) the participants in REACH meet the following criteria:
Inclusion criteria:
(a) Were aged 45+ years;
(b) Had known cardiovascular disease (peripheral arterial disease, coronary artery disease, cerebrovascular disease) or at least three atherosclerosis risk factors [current smoking, diabetic nephropathy, systolic blood pressure greater than 150 mmHg, Ankle Brachial Index (ABI) < 0.9 in either leg at rest, asymptomatic Carotid Stenosis, and/or the presence of at least one carotid plaque].
(c) Were physically able to attend the practice and were approved by their usual treating general practitioner
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Deceased since enrolment in REACH registry.

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/08/2009
Actual
12/02/2010
Date of last participant enrolment
Anticipated
Actual
24/11/2010
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] 237537 0
Government body
Name [1] 237537 0
National Health and Medical Research Council (NHMRC)
Country [1] 237537 0
Australia
Funding source category [2] 288489 0
Charities/Societies/Foundations
Name [2] 288489 0
Royal Australian College of General Practice
Country [2] 288489 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Menzies Research Institute
Private Bag 23
Hobart, TAS 7001
Country
Australia
Secondary sponsor category [1] 237016 0
University
Name [1] 237016 0
Monash university
Address [1] 237016 0
Department of Epidemiology and Preventive Medicine
Alfred Hospital,
Prahran, VIC 3127
Country [1] 237016 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243673 0
Human Research Ethics Committee (Tasmania) Network
Ethics committee address [1] 243673 0
Office of Research Services
University of Tasmania
Private Bag 1
Hobart, TAS 7001
Ethics committee country [1] 243673 0
Australia
Date submitted for ethics approval [1] 243673 0
Approval date [1] 243673 0
23/02/2009
Ethics approval number [1] 243673 0
H10410

Summary
Brief summary
To validate a general practice nurse method of measuring the ankle-brachial index which is used to diagnose peripheral arterial disease.
Trial website
N/A
Trial related presentations / publications
Nelson MR, Quinn S, Reid CM, Winzenberg T. Ankle brachial index determination by oscillometric method in general practice (ABIDING). Heart Foundation Conference, Brisbane 2009. Nelson M, Quinn S, Reid C, Winzenberg T. ANKLE brachial index determination by oscillometric method in general practice (ABIDING). General Practice and Primary Health Care Research Conference, Melbourne 2009.
Nelson M, Quinn S, Reid C, Winzenberg T. ABIDING – extending the utility of oscillometric blood pressure devices in general practice. HBPRCA ASM, Sydney 2009.
Nelson M, Reid C, Winzenberg T, Quinn S, Howes F. Ankle-brachial index determination by oscillometric method in general practice (ABIDING). 8th International Congress on Coronary Artery Disease, Prague, Czech Republic, 2009.
Nelson MR, Quinn S, Winzenberg TM, Howes F, Shiel L, Reid CM. Ankle-Brachial Index determination and peripheral arterial disease diagnosis by an oscillometric blood pressure device in primary care: validation and diagnostic accuracy study. BMJ Open 2012;2:e001689.
Nelson MR, Quinn S, Reid CM, Shiel L, Winzenberg TM. Results of the ankle brachial index determination by oscillometric method in general practice study (ABIDING). PHC ASM Canberra 2012.
Nelson MR, Quinn S, Winzenberg TM, Howes F, L Shiel, Reid CM. Principal results of the ankle brachial index determination by oscillometric method in general practice study. GP12 Gold Coast 2012.
Nelson MR, Quinn S, Winzenberg TM, Howes F, L Shiel, Reid CM. Principal results of the ankle brachial index determination by oscillometric method in general practice study. ISH Sydney 2012.
Nelson MR, Quinn S, Winzenberg TM, Howes F, L Shiel, Reid CM. Principal results of the ankle brachial index determination by oscillometric method in general practice study. NAPCRG Annual meeting New Orleans USA 2012.
Nelson M, Reid C, Winzenberg T, Quinn S, Howes F. Ankle brachial index determination by oscillometric method in general practice (ABIDING). WONCA World Conference of Family Doctors, Cancun Mexico 2010.
Tun NN, Nelson MR. A literature review of Doppler ultrasound versus oscillometric methods for determination of ankle brachial index. PHCRED Seventh Tasmanian Annual Symposium, Launceston 2010.
Public notes

Contacts
Principal investigator
Name 30090 0
Prof Mark Nelson
Address 30090 0
University of Tasmania
Private Bag 23
Hobart 7001
Tasmania
Country 30090 0
Australia
Phone 30090 0
+61 3 6226 4734
Fax 30090 0
Email 30090 0
Mark.Nelson@utas.edu.au
Contact person for public queries
Name 13337 0
Mark Nelson
Address 13337 0
Private Bag 33
Hobart, TAS 7001
Country 13337 0
Australia
Phone 13337 0
+61 3 6226 4734
Fax 13337 0
+61 3 6226 4770
Email 13337 0
mark.nelson@utas.edu.au
Contact person for scientific queries
Name 4265 0
Mark Nelson
Address 4265 0
Private Bag 33
Hobart, TAS 7001
Country 4265 0
Australia
Phone 4265 0
+61 3 6226 4734
Fax 4265 0
+61 3 6226 4770
Email 4265 0
mark.nelson@utas.edu.au

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

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