Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000342213
Ethics application status
Approved
Date submitted
30/04/2009
Date registered
25/05/2009
Date last updated
25/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of pretreatment with a loading dose of intracoronary adenosine on periprocedural myonecrosis in patients undergoing percutaneous coronary intervention in the setting of non ST segment elevation acute coronary syndrome
Scientific title
The effect of pretreatment with a loading dose of intracoronary adenosine on periprocedural myonecrosis in patients having percutaneous coronary intervention in the setting of non ST segment elevation acute coronary syndrome.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non ST elevation acute coronary syndrome 4700 0
Condition category
Condition code
Cardiovascular 5014 5014 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intracoronary adenosine, 4mg (ADENOCOR)made up with 4mls of normal saline, as a single bolus dose.
Intervention code [1] 4461 0
Treatment: Drugs
Comparator / control treatment
Normal saline , 4mls, given intracoronary as a single bolus
Control group
Placebo

Outcomes
Primary outcome [1] 5854 0
Periprocedural myocardial injury characterised by troponin and myocardial Creatine Kinase (CKMB) rise.
Timepoint [1] 5854 0
8 and 24 hrs after percutaneous coronary intervention (PCI)
Secondary outcome [1] 241882 0
Angiographic outcomes - Thrombolysis in myocardial infarction (TIMI) flow grade, Myocardial blush grade
Timepoint [1] 241882 0
At the end of PCI

Eligibility
Key inclusion criteria
Patients presenting with non ST segment elevation acute coronary syndrome (NSTEACS)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ST segment elevation myocardial infarction (STEMI), Cardiogenic Shock, bradycardia or Atrioventricular (AV) block, refractory ventricular arrhythmias, severe asthma, allergy to adenosine, totally occluded arteries resulting in TIMI grade 0 antegrade flow, pregnancy, unconscious or not for resuscitation,

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients fulfilling inclusion criteria are provided with trial information sheet and consented in an informed fashion.

Those who require follow on percutaneous coronary intervention after their diagnostic angiogram are recruited into the trial.

Eligible pateints are randomised to recieve intracoronary adenosine (4mg adenosine made up with 4mls of normal saline) or placebo (4mls of normal saline).

Allocation is held in sealed envelopes which are opened after the decision to recruit the patient immediately prior to angioplasty.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence is computer generated (www.randomisation.com) and is performed by a nurse not involved in the trial. He has no role in determining eligibility and entry of patients, enrolling or consenting them in to the trial, nor with administering treatment or assessing outcome.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
144
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4879 0
Hospital
Name [1] 4879 0
Monash Heart
Country [1] 4879 0
Australia
Funding source category [2] 4880 0
University
Name [2] 4880 0
Monash cardiovascular research centre
Country [2] 4880 0
Australia
Primary sponsor type
Hospital
Name
Monash Medical Center
Address
246 Clayton Road
Clayton 3168 VIC
Country
Australia
Secondary sponsor category [1] 4412 0
University
Name [1] 4412 0
Monash cardiovascular research
Address [1] 4412 0
246 Clayton Road
Clayton 3168
Country [1] 4412 0
Australia
Other collaborator category [1] 657 0
Hospital
Name [1] 657 0
Prince of Wales Hospital
Address [1] 657 0
Barker St Randwick 2031 NSW
Country [1] 657 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6945 0
Southern Health Research Directorate
Ethics committee address [1] 6945 0
Level 4, Main Block
246 Clayton Road
Clayton 3168
Ethics committee country [1] 6945 0
Date submitted for ethics approval [1] 6945 0
Approval date [1] 6945 0
01/04/2009
Ethics approval number [1] 6945 0
09053B

Summary
Brief summary
Adenosine has never been studied in coronary angioplasty in the setting of non ST segment elevation acute coronary syndrome. With promising observations of the benefits of adenosine in both elective and primary angioplasty settings, we hypothesise that intracoronary adenosine may prevent myocyte death (periprocedural myonecrosis) in this groups of patients undergoing coronary angioplasty.

We hypothesise that pretreatment with a intracoronary bolus dose of adenosine before coronary angioplasty decreases the amount of periprocedural myonecrosis in patients with non ST segment elevation acute coronary syndrome
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29552 0
Address 29552 0
Country 29552 0
Phone 29552 0
Fax 29552 0
Email 29552 0
Contact person for public queries
Name 12799 0
Dr Brian Ko
Address 12799 0
Monash Heart
246 Clayton Road
Clayton 3168
Country 12799 0
Australia
Phone 12799 0
+61 414013976
Fax 12799 0
Email 12799 0
[email protected]
Contact person for scientific queries
Name 3727 0
Dr Brian Ko
Address 3727 0
Monash Heart
246 Clayton Road
Clayton 3168
Country 3727 0
Australia
Phone 3727 0
+61 414013976
Fax 3727 0
Email 3727 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.