Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000280000
Ethics application status
Approved
Date submitted
31/03/2010
Date registered
7/04/2010
Date last updated
11/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The NACIAM Study – Assessing the benefit of N-Acetylcysteine (NAC) in acute heart attacks.
Scientific title
The early use of N-Acetyl Cysteine In Acute Myocardial Infarction to assess the impact of early NAC therapy in reducing myocardial infarct size as determined by Cardiac Magnetic Resonance Imaging (CMRI).
Secondary ID [1] 1578 0
none
Universal Trial Number (UTN)
U1111-1114-5373
Trial acronym
NACIAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute ST Elevation Myocardial Infarction requiring urgent revascularisation (angioplsty or stent). The ST segment refers to that of QRST complex as represented on a 12 lead ECG (Electrocardiograph). 257042 0
Condition category
Condition code
Cardiovascular 257202 257202 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous (I.V.) N-Acetyl Cysteine (NAC) 15g or saline placebo in 500 mls 5% Dextrose delivered at 20 mg/min for 1st hour then 10 mg/min for next 47 hours. This is a one-off treatment.
Intervention code [1] 256231 0
Treatment: Drugs
Intervention code [2] 256268 0
Prevention
Comparator / control treatment
Corresponding saline placebo is administered as soon as the decision for acute intervention has been made.
Control group
Placebo

Outcomes
Primary outcome [1] 258110 0
Myocardial infarct size as determined by Cardiac Magnetic Resonance Imaging (MRI).
Timepoint [1] 258110 0
First post-infarct week.
Secondary outcome [1] 263733 0
Angiography patency and infarct size measured at time of angiography.
Timepoint [1] 263733 0
Measured at angiography during index event.

Eligibility
Key inclusion criteria
Acute ST segment elevation myocardial infarction (STEMI) with primary percutaneous coronary intervention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous myocardial infarction.
Permanent pacemaker or implantable defibrillator (cardiac MRI contra-indicated).
Decision to administer open-label NAC for renoprotection

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 presenting to participating hospitals with an acute STEMI, will be allocated blinded, numbered and sealed treatment boxes by number sequential randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment arms will be pre-determined by a computer-generated algorithm with randomisation blocks of 10.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/02/2010
Actual
4/03/2010
Date of last participant enrolment
Anticipated
1/01/2012
Actual
9/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256733 0
Charities/Societies/Foundations
Name [1] 256733 0
The National Heart Foundation of Australia
Country [1] 256733 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital Cardiology Unit
Address
28 Woodville Road
Woodville
South Australia 5011
Country
Australia
Secondary sponsor category [1] 256019 0
None
Name [1] 256019 0
Address [1] 256019 0
Country [1] 256019 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258743 0
Central Northern Adelaide Health Service Ethics of Human Research Committee, The Queen Elizabeth Hospital (TQEH), The Lyell McEwin Hospital (LMH) and Modbury Hospital, (MH)
Ethics committee address [1] 258743 0
The Queen Elizabeth Hospital
Adelaide
Ethics committee country [1] 258743 0
Australia
Date submitted for ethics approval [1] 258743 0
30/05/2008
Approval date [1] 258743 0
30/09/2008
Ethics approval number [1] 258743 0
2008087

Summary
Brief summary
N-Acetylcysteine (NAC) is an anti-oxidant which also potentiates the action of nitroglycerine. When used with nitrates in the context of acute myocardial infarction, it may reduce infarct size by minimising reperfusion injury as well as potentiating nitroglycerine's vasodilating and anti-platelet effects. The NACIAM trial is a randomised, double-blind, placebo-controlled study assessing the impact of early NAC therapy in reducing infarct size (as assessed by cardiac MRI) in patients with acute ST elevation myocardial infarction receiving intravenous nitrate therapy and undergoing primary percutaneous coronary intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30986 0
Prof John Beltrame
Address 30986 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
SA 5011
Country 30986 0
Australia
Phone 30986 0
+61 8 8222 6000
Fax 30986 0
Email 30986 0
[email protected]
Contact person for public queries
Name 14233 0
Prof Professor John Beltrame
Address 14233 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville
South Australia 5011
Country 14233 0
Australia
Phone 14233 0
+61 8 8222 6000
Fax 14233 0
+61 8 8222 7201
Email 14233 0
[email protected]
Contact person for scientific queries
Name 5161 0
Prof Professor John Beltrame
Address 5161 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville
South Australia 5011
Country 5161 0
Australia
Phone 5161 0
+61 8 8222 6000
Fax 5161 0
+61 8 8222 7201
Email 5161 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.