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
ACTRN12615001234505
Ethics application status
Approved
Date submitted
5/11/2015
Date registered
11/11/2015
Date last updated
15/09/2020
Date data sharing statement initially provided
15/09/2020
Date results information initially provided
15/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of optical coherence (OCT), imaging to examine the structure and form of coronary plaques following a heart attack.
Scientific title
Multi-modality imaging and biomarkers to improve risk stratification for secondary prevention after acute coronary syndrome.
Secondary ID [1] 287813 0
MTVR01-2015
Universal Trial Number (UTN)
Trial acronym
MOTIVATOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 296688 0
Non-ST elevation Myocardial Infarction 296689 0
Thrombolysed STEMI 296690 0
High risk Acute coronary syndrome 306592 0
Condition category
Condition code
Cardiovascular 296926 296926 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High resolution catheter based laser imaging using optical coherence tomography (OCT) is used during coronary angiography. It is a routine procedure used in select patients (at the Cardiologists discretion) to view high resolution images from inside the blood vessels. The OCT imaging will add 10- 15 minutes to the angiogram procedure.
A functional PET scan that detects the activity of coronary calcium build-up will take approximately 30 minutes. It is not a routine procedure.
Blood samples will be taken at the baseline assessment (once consent is given) and stored to establish a bio-bank. The samples will be used investigate how fast atherosclerosis and calcium build-up occurs in the coronary arteries.
A CT-scan that determines 3-dimensional trajectory for calculation of stress distribution on artery walls is a commonly used imaging modality in patients. This scan also takes approximately 30 minutes.
Intervention code [1] 293205 0
Diagnosis / Prognosis
Comparator / control treatment
No group control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296534 0
Major Adverse Cardiac Events (Cardiovascular disease, death, MI, revascularisation). Via telephone follow-up and hospital records.
Timepoint [1] 296534 0
5 years post OCT.
Secondary outcome [1] 318736 0
Accuracy of OCT as a predictor of future MACE risk, assessed with OCT data and review of hospital records for MACE outcomes.
Timepoint [1] 318736 0
5 years post OCT

Eligibility
Key inclusion criteria
Patients presenting to hospital with:
NSTEMI proceeding to in-patient angiography
STEMI proceeding to non-emergency in-patient angiography (late presentation or reperfused without PCI)
All major epicardial coronary arteries suitable for for OCT prior to stenting (intervention).
The time point is during that hospital admission for the MI event. Simply in-patient angiography.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
eGFR <40ml/min with diabetes mellitus
unlikely to survive for at least 3 years due to a co-morbidity
coronary anatomy unsuitable for OCT
pregnancy
prior coronary Bypass Graft
STEMI treated with PCI.

Study design
Purpose of the study
Prevention
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Target revised downward to 75 as sufficient to achieve study aims
Date of first participant enrolment
Anticipated
30/11/2015
Actual
30/11/2015
Date of last participant enrolment
Anticipated
Actual
1/06/2018
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
75
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4582 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 12187 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 292338 0
Charities/Societies/Foundations
Name [1] 292338 0
Royal Perth Hospital Medical Research Foundation
Country [1] 292338 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Highway, Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 291018 0
None
Name [1] 291018 0
None
Address [1] 291018 0
Country [1] 291018 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293804 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 293804 0
Locked Bag 100, Palmyra DC WA 6961
Ethics committee country [1] 293804 0
Australia
Date submitted for ethics approval [1] 293804 0
04/03/2015
Approval date [1] 293804 0
20/08/2015
Ethics approval number [1] 293804 0
REG 15-033

Summary
Brief summary
Patients who present with an acute coronary syndrome remain at high risk of further events in subsequent years. Better identification of individuals at high risk can allow better targeting of novel therapies and resources.
This study will create an imaging bio-bank that enables testing of multiple novel strategies involving new imaging, image analysis and biomarker approaches alone or in combination for improved risk stratification and targeting of prevention.
Prospective follow-up in the cohort for outcomes enables the predictive value to be tested in a pilot data setting.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 61378 0
Prof Carl Schultz
Address 61378 0
Cardiology Department, Royal Perth Hospital 197 Wellington Street, Perth WA 6000
Country 61378 0
Australia
Phone 61378 0
+61 (0) 8 9224 2067
Fax 61378 0
Email 61378 0
[email protected]
Contact person for public queries
Name 61379 0
Ms Michelle Bonner
Address 61379 0
Cardiology Research Department, Royal Perth Hospital 197 Wellington Street, Perth WA 6000
Country 61379 0
Australia
Phone 61379 0
+61 (0) 8 9224 8609
Fax 61379 0
Email 61379 0
[email protected]
Contact person for scientific queries
Name 61380 0
Prof Carl Schultz
Address 61380 0
Cardiology Department, Royal Perth Hospital 197 Wellington Street, Perth WA 6000
Country 61380 0
Australia
Phone 61380 0
+61 (0) 8 9224 2067
Fax 61380 0
Email 61380 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseCoronary artery 18F-NaF PET analysis with the use of an elastic motion correction software.2020https://dx.doi.org/10.1007/s12350-018-01587-7
EmbaseLow Endothelial Shear Stress Is Associated With High-Risk Coronary Plaque Features and Microcalcification Activity.2021https://dx.doi.org/10.1016/j.jcmg.2021.06.016
EmbaseCoronary artery segmentation from intravascular optical coherence tomography using deep capsules.2021https://dx.doi.org/10.1016/j.artmed.2021.102072
EmbaseCoronary 18F-sodium fluoride PET detects high-risk plaque features on optical coherence tomography and CT-angiography in patients with acute coronary syndrome.2021https://dx.doi.org/10.1016/j.atherosclerosis.2020.12.010
N.B. These documents automatically identified may not have been verified by the study sponsor.