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Trial registered on ANZCTR


Registration number
ACTRN12610000186055
Ethics application status
Approved
Date submitted
18/02/2010
Date registered
2/03/2010
Date last updated
28/11/2019
Date data sharing statement initially provided
28/11/2019
Date results information initially provided
28/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of endothelial function in populations at high cardiovascular risk
Scientific title
cross-sectional study of endothelium function in patients with type II diabetes and of high cardiovascular risk receiving standard clinical care
Secondary ID [1] 1447 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vascular function 256828 0
Condition category
Condition code
Cardiovascular 256975 256975 0 0
Diseases of the vasculature and circulation including the lymphatic system
Metabolic and Endocrine 257041 257041 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
a) Participant involvement is 1 visit (4 hrs) with fasting 6hrs immediately prior to visit
b) Strain gauge plethysmography and peripheral arterial tone technology (EndoPAT) will be used to assess endothelial function
c) Vasodilators sodium nitroprusside (Nitropress: 2 micrograms/min, 4 micrograms/min and 8 micrograms/min) and acetylcholine chloride (Miochol-E: 9.25 micrograms/min, 18.5 micrograms/min, 37 micrograms/min) will be delivered for 2 min each via the brachial artery during the strain gauge plethysmography. This will enable measurement of endothelial mediated vasodilation
Intervention code [1] 256031 0
Early detection / Screening
Comparator / control treatment
The untreated arm (contralateral to the cannulated arm) will be the comparator for the strain gauge plethysmography test. The test will be performed on this arm in the absence of brachial artery cannulation and therefore sodium nitroprusside and acetylcholine chloride. Healthy volunteers will be the comparator group.
Control group
Active

Outcomes
Primary outcome [1] 257865 0
Vascular endothelial function using strain gauge plethysmography and peripheral arterial tone technology
Timepoint [1] 257865 0
All measures are assessed on the day of the single visit
Secondary outcome [1] 263318 0
Blood analysis using in vitro laboratory assays for inflammatory marker determination, Endothelial Progenitor Cell identification and lipid measurements.
Timepoint [1] 263318 0
measures are assessed on the day of the single visit or at a later date using fresh or frozen plasma collected on the day of the single visit from the cannulated arm

Eligibility
Key inclusion criteria
Study Group:
Type II diabetes
4 to 6 months post acute coronary syndrome

Comparator Group
of general good health and non-smoking
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Study group:
type 1 Diabetes
Impaired liver or renal function
Uncontrolled hypertension
heart failure (class III or V)
Any other serious Illness
on more than 2 anti-diabetic drug treatments

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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 256535 0
Self funded/Unfunded
Name [1] 256535 0
Baker IDI Heart and Diabetes Research Institute
Address [1] 256535 0
75 Commercial rd, Melbourne, VIC 3004
Country [1] 256535 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Baker IDI Heart and Diabetes Research Institute
Address
75 Commercial rd, Melbourne, VIC 3004
Country
Australia
Secondary sponsor category [1] 255876 0
None
Name [1] 255876 0
Address [1] 255876 0
Country [1] 255876 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258588 0
The Alfred Human Research Ethics Committee
Ethics committee address [1] 258588 0
Alfred Hospital
Commercial Rd
Prahran, VIC
3181
Ethics committee country [1] 258588 0
Australia
Date submitted for ethics approval [1] 258588 0
12/01/2010
Approval date [1] 258588 0
11/03/2010
Ethics approval number [1] 258588 0
4/10 (Ref number for Alfred HREC)

Summary
Brief summary
Endothelial dysfunction is a disease process that occurs throughout the vascular system and results in abnormal regulation of blood vessel tone and the loss of atheroprotective properties of normal endothelium.
The presence of endothelial dysfunction in coronary or peripheral arteries is an independent predictor of future cardiovascular events.
While it is well known that vascular dysfunction is associated with type II diabetes, the effects of standard treatments for this disease such as statins and fibrates on vascular function is less clear. This is even more so for type II diabetes patients with acute coronary syndrome.
The assessment of arterial endothelial function using strain gauge plethysmography is considered the “gold standard” of endothelial function testing. However, it is invasive and not applicable to large patient populations. Therefore, recent non-invasive techniques such as Endo-PAT have been developed to overcome these shortfalls.
Endo-PAT is a non-invasive peripheral arterial tonometer (PAT) which measures the changes in pulse wave amplitude (PWA) in the fingertip of the index finger. While Endo-PAT is approved by the U.S Food and Drug Authority, its reliability in detecting endothelial dysfunction in different patient cohorts is still being established.

Aims:
Our study aims to answer two research questions: Do patients at high cardiovascular risk under standard clinical care exhibit endothelial dysfunction? We will examine endothelial function using both forearm venous occlusion plethysmography and Endo-PAT. The second research question is how reliable is the EndoPAT device in detecting endothelial dysfunction compared to strain gauge plethysmography?
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 30840 0
Address 30840 0
Country 30840 0
Phone 30840 0
Fax 30840 0
Email 30840 0
Contact person for public queries
Name 14087 0
Dr Natalie Lumsden
Address 14087 0
Baker IDI Heart and Diabetes Research Institute
75 Commercial Rd, Melbourne, VIC, 3004
Country 14087 0
Australia
Phone 14087 0
+61 3 8532 1359
Fax 14087 0
Email 14087 0
Natalie.Lumsden@bakeridi.edu.au
Contact person for scientific queries
Name 5015 0
Dr Natalie Lumsden
Address 5015 0
Baker IDI Heart and Diabetes Research Institute
75 Commercial Rd, Melbourne, VIC, 3004
Country 5015 0
Australia
Phone 5015 0
+61 3 8532 1359
Fax 5015 0
Email 5015 0
Natalie.Lumsden@bakeridi.edu.au

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 other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 5922 0
Lumsden et al, Endothelial dysfunction in patients with type 2 diabetes post acute coronary syndrome. Diab Vasc Dis Res. 2013 Ju; 10(4):368-74.
Attachments [1] 5922 0
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary