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
ACTRN12615000321549
Ethics application status
Approved
Date submitted
6/03/2015
Date registered
9/04/2015
Date last updated
11/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Does flow measurement guided stenting of non-culprit lesions as compared with visual assessment guided stenting in patients presenting with a heart attack improve outcomes.
Scientific title
A randomized controlled trial to investigate Fractional Flow Reserve (FFR) guided intervention compared to visual assessment of non-culprit lesions in patients presenting with non-ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI) on cardiac death, MI and revascularization
Secondary ID [1] 286325 0
nil
Universal Trial Number (UTN)
U1111-1165-4375
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ST elevation myocardial infarction (STEMI) 294423 0
and non-ST elevation myocardial infarction (non-STEMI) 294424 0
acute coronary syndromes 294428 0
Condition category
Condition code
Cardiovascular 294733 294733 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fractional flow reserve (FFR)-guided stenting vs. visual assessment stenting.
FFR will be measured with a coronary pressure wire (St Jude Medical) with maximum hyperaemia achieved using adenosine administered at a rate of 140ug per kilogram per minute over 3 minutes given via a central vein. The procedure takes approximately 15 minutes and the distal pressure beyond a coronary stenosis is compared to a proximal pressure reflecting aortic pressure
Intervention code [1] 291367 0
Treatment: Devices
Comparator / control treatment
Visual assessment stenting which will be made by looking at the stenosis as assessed by angiography and estimating what the degree of the stenosis is
Control group
Active

Outcomes
Primary outcome [1] 294495 0
Composite of cardiac death, myocardial infarction, and revascularization (including percutaneous coronary intervention and coronary artery bypass grafting)at 30 days and 2 years after randomization
This will be assessed by linkage to National data sets
Timepoint [1] 294495 0
At 30 days and 2 years after randomization
Secondary outcome [1] 313458 0
cost effectiveness by counting and comparing costs in both arms eg hospital costs including equipment, length of hospital stay and costs of complications and long term costs of readmissions and procedures and complications
Timepoint [1] 313458 0
At 30 days and 2 years after randomization assessed from patient and National records
Secondary outcome [2] 313459 0
cardiac death
Timepoint [2] 313459 0
at 30 days and 2 years after randomization assessed from patient and National records
Secondary outcome [3] 313680 0
total mortality
Timepoint [3] 313680 0
at 30 days and 2 years after randomization assessed from patient and National records
Secondary outcome [4] 313681 0
stroke
Timepoint [4] 313681 0
at 30 days and 2 years after randomization from patient and national records
Secondary outcome [5] 313684 0
radiation dose
Timepoint [5] 313684 0
At time of cardiac catheterization from hospital records and ANZAC QI which is a National web based electronic program recording data after an acute coronary syndrome
Secondary outcome [6] 313686 0
bleeding
Timepoint [6] 313686 0
from hospital records and ANZAC QI which is a National web based electronic program recording data after an acute coronary syndrome
At 30 days and 2 years after randomization from patient records
Secondary outcome [7] 313687 0
Incidence of the primary composite in the subset of ulcerated, associated with thrombus, or complex coronary stenosis
Timepoint [7] 313687 0
At 30 days and 2 years after randomization from hospital records and ANZAC QI and National records
Secondary outcome [8] 313893 0
MI
Timepoint [8] 313893 0
At 30 days and 2 years after randomization from hospital records and ANZAC QI and National records
Secondary outcome [9] 313894 0
revascularization
Timepoint [9] 313894 0
At 30 days and 2 years after randomization from hospital records and ANZAC QI and National records

Eligibility
Key inclusion criteria
Patients with STEMI undergoing primary angioplasty, rescue PCI or PCI following fibrinolytic therapy, or PCI for non-STEMI
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Left main coronary artery disease, previous bypass surgery, cardiogenic shock, extremely tortuous or calcified coronary vessels, life expectancy < 2years, pregnancy, contraindications to DES placement, Patients in whom the preferred strategy is CABG, contraindications to dual antiplatelet therapy, LVEF<30%,randomization previously in the trial

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)
central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomization table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
event driven
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculations estimate with 80% probability that a treatment difference will be detected with a two sided 0.05 significance if the true hazard is 0.6. Based on assumption that the accrual period will be 1.5 years and the follow-up will be 3 years and the event rate in the stent arm is 5% 122 primary events are requiredBaseline demographic, clinical, and treatment characteristics of the two randomized groups will be listed with continuous variables presented as medians (25th, 75th percentiles) and compared using ANOVA F test when assumption of normality was satisfied; otherwise, the Kruskal-Wallis test will be used. Categorical variables will be presented as counts (proportions) and compared using the chi-square test when appropriate; otherwise, an exact test will be used. The relationship between randomised groups and clinical outcomes will be assessed by fitting a Cox proportional hazards model for time-to-first event. Variables included in the adjusted model will include age, weight, sex, STEMI presentation, , time from presentation to randomization, family history of CAD, hypertension, hyperlipidemia, diabetes, current or recent smoker, previous MI, previousPCI, previous peripheral arterial disease, previous atrial fibrillation, previous heart failure, systolic blood pressure at baseline, heart rate at baseline, hemoglobin, creatinine, aspirin at baseline, P2Y12 inhibitor at baseline, beta blocker at baseline, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker at baseline, statin at baseline, study treatment (FFR vs visual stenting),
All statistical tests will be performed at a significance level of 0.05.



Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
10/04/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
850
Accrual to date
Final
Recruitment outside Australia
Country [1] 6721 0
New Zealand
State/province [1] 6721 0

Funding & Sponsors
Funding source category [1] 290895 0
Government body
Name [1] 290895 0
Health Research Council of New Zealand
Country [1] 290895 0
New Zealand
Primary sponsor type
Individual
Name
Professor Harvey White
Address
Cardiology department
Auckland City Hospital
Level 3. Building 32
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 289634 0
Government body
Name [1] 289634 0
Health Research Council of New Zealand
Address [1] 289634 0
3, Procare building 110 Stanley street, Parnell, Auckland 1010
Country [1] 289634 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292497 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 292497 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 292497 0
New Zealand
Date submitted for ethics approval [1] 292497 0
13/01/2015
Approval date [1] 292497 0
11/02/2015
Ethics approval number [1] 292497 0
15/NTB/11

Summary
Brief summary
The study hypothesis is that assessing the efficacy of stenting heart arteries other than those that caused a heart attack, either by assessing the narrowings by visual assessment or by measuring blood flow across the narrowings, will result in different patient outcomes and costs.
Both approaches are used in clinical practice but it not known which is better.
There will be 850 patients randomized to either of these approaches and patients will be followed for 2 years. Outcomes will be assessed by National records with names anonymised and will include heart related deaths, heart attacks and need for stenting or bypass surgery. The cost-effectiveness of each approach will also be compared by counting the costs of each procedure and outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55002 0
Prof Harvey White
Address 55002 0
Auckland City Hospital
2 Park Road
Cardiology Department
level 3.Building 32
Auckland 1142
Country 55002 0
New Zealand
Phone 55002 0
+64 9 6309992
Fax 55002 0
+64 9 6309915
Email 55002 0
[email protected]
Contact person for public queries
Name 55003 0
Prof Harvey White
Address 55003 0
Auckland City Hospital
2 Park Road
Cardiology Department
level 3.Building 32
Auckland 1142
Country 55003 0
New Zealand
Phone 55003 0
+64 9 6309992
Fax 55003 0
+64 9 6309915
Email 55003 0
[email protected]
Contact person for scientific queries
Name 55004 0
Prof Harvey White
Address 55004 0
Auckland City Hospital
2 Park Road
Cardiology Department
level 3.Building 32
Auckland 1142
Country 55004 0
New Zealand
Phone 55004 0
+64 9 6309992
Fax 55004 0
+64 9 6309915
Email 55004 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.