ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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 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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Vascular function

Condition category

Condition code

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Metabolic and Endocrine

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]

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]

Vascular endothelial function using strain gauge plethysmography and peripheral arterial tone technology

Timepoint [1]

All measures are assessed on the day of the single visit

Secondary outcome [1]

Blood analysis using in vitro laboratory assays for inflammatory marker determination, Endothelial Progenitor Cell identification and lipid measurements.

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

30/03/2010

Actual

30/03/2010

Date of last participant enrolment

Anticipated

Actual

1/03/2011

Date of last data collection

Anticipated

Actual

18/11/2011

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Baker IDI Heart and Diabetes Research Institute

Address [1]

75 Commercial rd, Melbourne, VIC 3004

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Alfred Human Research Ethics Committee

Ethics committee address [1]

Alfred Hospital
Commercial Rd
Prahran, VIC
3181

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/01/2010

Approval date [1]

11/03/2010

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Natalie Lumsden

Address

Baker IDI Heart and Diabetes Research Institute
75 Commercial Rd, Melbourne, VIC, 3004

Country

Australia

Phone

+61 3 8532 1359

Fax

Natalie.Lumsden@bakeridi.edu.au

Contact person for scientific queries

Name

Dr Natalie Lumsden

Address

Baker IDI Heart and Diabetes Research Institute
75 Commercial Rd, Melbourne, VIC, 3004

Country

Australia

Phone

+61 3 8532 1359

Fax

Natalie.Lumsden@bakeridi.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

Trial Review

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