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Trial registered on ANZCTR


Registration number
ACTRN12618001680257p
Ethics application status
Submitted, not yet approved
Date submitted
20/09/2018
Date registered
11/10/2018
Date last updated
11/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does detailed imaging of buildup in the heart arteries improve prediction of future heart problems in patients hospitalised with heart attack.
Scientific title
Coronary imaging with optical coherence tomography and computational modelling for the prediction of major adverse cardiovascular events in patients with high risk coronary artery disease.
Secondary ID [1] 295981 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
The PUFFbAll study
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Coronary heart disease 309494 0
Myocardial infarction 309732 0
Condition category
Condition code
Cardiovascular 308331 308331 0 0
Coronary heart disease
Cardiovascular 308650 308650 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All patients undergoing coronary angiography and angioplasty in the study will have optical coherence tomography (OCT) imaging performed on the proximal 5cm of at least 2 of the 3 major epicardial arteries. The OCT catheter is positioned over a guide wire after the angioplasty procedure and is mostly used to optimise stunting procedures. After imaging the stunted after at least one (to maximum 2) additional arteries will also be imaged. The additional OCT imaging will add approximately 5-10 minutes to procedure duration and will increase the volume of radiographic contrast used by a small amount, approximately 30 ml.
Intervention code [1] 312312 0
Diagnosis / Prognosis
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307307 0
Patient Oriented Clinical Events (POCE) which is a composite of: all-cause death, any myocardial infarction and any coronary revascularisation which will be collected via telephone follow up of patients and their GP's.
Timepoint [1] 307307 0
3 years post OCT
Secondary outcome [1] 351436 0
Cardiac death collected by telephone follow-up.
Timepoint [1] 351436 0
3 years post OCT
Secondary outcome [2] 352344 0
Myocardial infarction collected by telephone follow-up.
Timepoint [2] 352344 0
3 years post OCT
Secondary outcome [3] 352614 0
Coronary revascularisation collected by telephone follow-up
Timepoint [3] 352614 0
3 year post OCT
Secondary outcome [4] 352618 0
Hospitalisation for a cardiac cause - Stroke collected by telephone follow-up
Timepoint [4] 352618 0
3 years post OCT
Secondary outcome [5] 352619 0
Hospitalisation for a cardiac cause - Heart failure collected by telephone follow-up
Timepoint [5] 352619 0
3 years post OCT
Secondary outcome [6] 352620 0
Hospitalisation for a cardiac cause - atrial arrhythmia collected by telephone follow-up
Timepoint [6] 352620 0
3 years post OCT
Secondary outcome [7] 352621 0
Hospitalisation for a cardiac cause - Ventricular arrhythmia collected by telephone follow-up
Timepoint [7] 352621 0
3 years post OCT
Secondary outcome [8] 352622 0
Freedom from Angina (Seattle Angina Score) collected by telephone follow-up
Timepoint [8] 352622 0
3 years post OCT
Secondary outcome [9] 352623 0
Total Contrast use during index procedure (safety end-point), this information collected via medical notes
Timepoint [9] 352623 0
Baseline
Secondary outcome [10] 352624 0
Contrast nephropathy during index hospitalisation (safety end-point) collected from medical notes
Timepoint [10] 352624 0
Baseline

Eligibility
Key inclusion criteria
1. Patients who present to hospital with (1a) NSTEMI and who proceed to inpatient angiography or (1b) STEMI and who proceed to non-emergency in-patient angiography (late presenters, reperfused without PCI; patients who return to the catheter laboratory for in-patient treatment of non-infarct related additional coronary stenosis following initial primary PCI) or (1c) stable or unstable angina.
2. One or more functionally significant coronary lesion where PCI is deemed appropriate
3. Age 18 to 85 years old
4. At least 2 major epicardial coronary arteries (left anterior descending, left circumflex, right coronary arteries) suitable for per protocol OCT.
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. eGFR less than 40ml/min
2. Unlikely to survive for at least 3 years due to comorbidity
3. Coronary anatomy unsuitable for OCT
4. Pregnancy
5. Prior Coronary Artery Bypass Graft (CABG)
6. At the time of acute presentation with STEMI treated with primary PCI (see inclusion criteria 1b)
7. Refractory heart failure
8. Known significant non-compliance with medication

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Cox -regression will be used to identify a multivariable model of multi-modality (OCT, computation fluid dynamics) imaging and biomarkers to determine independent markers of adverse events. The coefficients from each parameter in the final model will be used to calculate a weighted average imaging risk score for each patient. The predictive value of the new imaging based model will be compared to a standard clinical risk score (GRACE), anatomical complexity (Syntax) and combined clinical/anatomical score (clinical Syntax) by calculating the C-statistic in preference to Net reclassification index. The component of the model that carries the most incremental predictive capacity will also be determined.

Recruitment
Recruitment status
Not yet recruiting
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)
NSW,WA,VIC
Recruitment hospital [1] 11771 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 11772 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 11773 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [4] 11775 0
John Hunter Hospital - New Lambton
Recruitment hospital [5] 11776 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [6] 11777 0
The Alfred - Prahran
Recruitment hospital [7] 11778 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 23866 0
6000 - Perth
Recruitment postcode(s) [2] 23867 0
6009 - Nedlands
Recruitment postcode(s) [3] 23868 0
6150 - Murdoch
Recruitment postcode(s) [4] 23870 0
2305 - New Lambton
Recruitment postcode(s) [5] 23871 0
3168 - Clayton
Recruitment postcode(s) [6] 23872 0
3004 - Prahran
Recruitment postcode(s) [7] 23873 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 20822 0
New Zealand
State/province [1] 20822 0
wellington
Country [2] 20823 0
New Zealand
State/province [2] 20823 0
Christchurch

Funding & Sponsors
Funding source category [1] 300576 0
University
Name [1] 300576 0
University of Western Australia
Address [1] 300576 0
35 Stirling Highway
CRAWLEY WA 60
Country [1] 300576 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Abbott Vascular
Address
299 Lane Cove Road
Macquarie Park NSW 2113
Country
Australia
Secondary sponsor category [1] 300068 0
None
Name [1] 300068 0
Address [1] 300068 0
Country [1] 300068 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301365 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 301365 0
Fiona Stanley Hospital
14 Barry Marshall Parade
Murdoch WA 6150
Ethics committee country [1] 301365 0
Australia
Date submitted for ethics approval [1] 301365 0
23/07/2018
Approval date [1] 301365 0
Ethics approval number [1] 301365 0

Summary
Brief summary
Cardiovascular disease remains a leading cause of morbidity and mortality in the developed world. Patients who have heart attacks remain the highest risk group, with up to 30% dying or having a further event in 3 years and improved methods of risk stratification are urgently needed. Intra-coronary optical coherence tomography (OCT) is a modality based on near infrared spectrum light with a superior resolution of the high risk components of coronary plaque.
We hypothesise that coronary OCT imaging at the time of routine coronary revascularisation when combined with computational methods will be superior to conventional risk scores in predicting future major adverse cardiovascular events.

Patients admitted with a Non ST elevation Myocardial Infarction (NSTEMI) and who proceed to inpatient angiography or a ST Elevation Myocardial Infarction (STEMI) and who proceed to non-emergency in-patient angiography or stable/unstable angina may be eligible to participate in the study.
The study aims to 1) to determine the predictive value of high risk plaque on OCT for patient oriented clinical events (POCE: recurrent myocardial infarction, coronary revascularisation or death). 2) to determine the predictive value of OCT derived low endothelial shear stress for recurrent POCE. 3) To determine the predictive value of OCT derived high endothelial shear stress for recurrent myocardial infarction and death 4) To develop a multivariate model for predicting residual risk based on multiple imaging parameters and determine its incremental predictive power when added to clinical risk factors and existing risk scores (eg. GRACE-score, Syntax score, Clinical Syntax score).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86762 0
Prof Carl Schultz
Address 86762 0
Department of Cardiology, 4th Floor A Block, Royal Perth Hospital, 197 Wellington Street, Perth, WA 6000
Country 86762 0
Australia
Phone 86762 0
+61 8 92242244
Fax 86762 0
+61 8 92242448
Email 86762 0
carl.schultz@health.wa.gov.au
Contact person for public queries
Name 86763 0
Prof Carl Schultz
Address 86763 0
Department of Cardiology, 4th Floor A Block, Royal Perth Hospital, 197 Wellington Street, Perth, WA 6000
Country 86763 0
Australia
Phone 86763 0
+61 8 92242244
Fax 86763 0
+61 8 92242448
Email 86763 0
carl.schultz@health.wa.gov.au
Contact person for scientific queries
Name 86764 0
Prof Carl Schultz
Address 86764 0
Department of Cardiology, 4th Floor A Block, Royal Perth Hospital, 197 Wellington Street, Perth, WA 6000
Country 86764 0
Australia
Phone 86764 0
+61 8 92242448
Fax 86764 0
+61 8 92242448
Email 86764 0
carl.schultz@health.wa.gov.au

No data has been provided for results reporting
Summary results
Not applicable