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Trial registered on ANZCTR


Registration number
ACTRN12613000135718
Ethics application status
Approved
Date submitted
30/01/2013
Date registered
4/02/2013
Date last updated
15/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effect of Limiting Radiographic Contrast Use in Patients Undergoing Emergent Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarct by Reflux Reduction.
Scientific title
Evaluating the effect of Limiting Radiographic Contrast Use in Patients Undergoing Emergent Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarct by Reflux Reduction.
Secondary ID [1] 281868 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 288249 0
ST segment elevation myocardial infarction 288250 0
Condition category
Condition code
Cardiovascular 288603 288603 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this study is to assess the utility of a simple device that reduces coronary contrast reflux in STEMI patients undergoing percutaneous coronary intervention.

The investigational device is a metal fixture designed to be affixed to an IV pole or be placed on a surface outside the sterile field. The fixture holds a standard injection syringe (provided separately). The ‘fixture’ comprises a holder for a standard sterile syringe and an adjustable metal weight that is applied to the plunger of the syringe. The purpose of the weight is to provide a constant resistive force. Sterile tubing attached to the syringe is coupled to a standard injection circuit at the manifold or via an additional 3-way stop-cock. In this way, the syringe serves as a reservoir during injections of contrast media routing a portion of contrast media away from the coronary catheter and attenuating the pressure that is supplied to the catheter’s hub. The affect of the system can be modified by adding or subtracting weights to the fixture, thereby changing the force applied to the reservoir syringe. The system can be completely bypassed by simply turning a stopcock.
Intervention code [1] 286430 0
Treatment: Devices
Comparator / control treatment
To establish a matched control group via a retrospective review of 100 patients in the Heart Center Database, who have undergone primary PCI, without the study device. Souce documents such as cath reports, lab reports and pathology reports will be used.
Time frame of the retrospective review would be 2011-2012.
Control group
Historical

Outcomes
Primary outcome [1] 288754 0
Basic indices of clinical cardiovascular and renal outcome during the hospital admission
This include the number of cardiovascular events, troponin, and CK levels.
Timepoint [1] 288754 0
4 hrs post PCI , 8 hrs post PCI, 24hrs post PCI, 48 hours post PCI
Secondary outcome [1] 300907 0
Image quality pictures generated with the conjunction use of the study device will be judged by a blinded investigator from a scale 1-3.
Timepoint [1] 300907 0
During PCI

Eligibility
Key inclusion criteria
Patient undergoing primary percutaneous coronary intervention for STEMI
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal of or inability to provide consent

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
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] 286645 0
Commercial sector/Industry
Name [1] 286645 0
Osprey Pty Ltd
Address [1] 286645 0
7600 Executive Drive, Eden Prairie, MN 55344
Country [1] 286645 0
United States of America
Primary sponsor type
Individual
Name
Prof David Kaye
Address
Alfred Hospital Commercial Road, Melbourne, Victoria 3004. Australia
Country
Australia
Secondary sponsor category [1] 285428 0
None
Name [1] 285428 0
None
Address [1] 285428 0
NA
Country [1] 285428 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288721 0
The Alfred Research & Ethics Unit
Ethics committee address [1] 288721 0
The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria 3004, Australia
Ethics committee country [1] 288721 0
Date submitted for ethics approval [1] 288721 0
28/11/2012
Approval date [1] 288721 0
11/01/2013
Ethics approval number [1] 288721 0
540/12

Summary
Brief summary
The purpose of this study is to assess the utility of a simple device that reduces coronary contrast reflux in STEMI patients undergoing percutaneous coronary intervention. The safety and efficacy of this device has recently been demonstrated in Alfred Hospital Study a performed at The Alfred Hospital (Project 347/12) in patients undergoing routine coronary angiography and non-acute PCI. This study showed that the device reduced overall contrast requirement by approximately 40%.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37486 0
Prof David Kaye
Address 37486 0
Heart Centre, The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria 3004, Australia
Country 37486 0
Australia
Phone 37486 0
+61 3 9076 3263
Fax 37486 0
Email 37486 0
david.kaye@bakeridi.edu.au
Contact person for public queries
Name 37487 0
Ms Vivian Mak
Address 37487 0
Heart Centre, The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria 3004, Australia
Country 37487 0
Australia
Phone 37487 0
+61 3 9076 2948
Fax 37487 0
Email 37487 0
v.mak@alfred.org.au
Contact person for scientific queries
Name 37488 0
Prof David Kaye
Address 37488 0
Heart Centre, The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria 3004, Australia
Country 37488 0
Australia
Phone 37488 0
+61 3 9076 3263
Fax 37488 0
Email 37488 0
david.kaye@bakeridi.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary