Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000297123
Ethics application status
Approved
Date submitted
1/02/2019
Date registered
27/02/2019
Date last updated
27/02/2019
Date data sharing statement initially provided
27/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Monitoring Of Stroke Endovascular Services (MOSES) study
Scientific title
Monitoring Of Stroke Endovascular Services (MOSES): A Clinical and Imaging Registry
Secondary ID [1] 296454 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
MOSES
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Endovascular thrombectomy outcomes 310242 0
Ischaemic stroke 311695 0
Condition category
Condition code
Stroke 308966 308966 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Months
Description of intervention(s) / exposure
The MOSES Registry will be a database of imaging and clinical stroke data of ischaemic stroke patients receiving thrombectomy. All clinical and imaging data is acquired as part of standard routine clinical practice. The imaging that will be uploaded, include:
- Pretreatment imaging (within 24 hours of stroke onset).
- Digital subtraction angiography (DSA) prior and post thrombectomy.
-Follow-up imaging (24-48 hours), in which may include Non-contrast computed tomography (NCCT)+/- computed tomography angiography (CTA) +/- computed tomography perfusion (CTP) and/or Magnetic resonance imaging (MRI).
- Any additional imaging during acute hospital admission (e.g., if there is a clinical deterioration).
Patients will be followed up at three-months, either face-to-face during out patient follow-up or via telephone. This includes Modified Rankin Scale and the EQ-5D-5L (quality of life).
Intervention code [1] 312783 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307938 0
Degree of disability and dependency in daily activities after stroke.
Timepoint [1] 307938 0
90 days post stroke onset, using modified Rankin Score
Secondary outcome [1] 365910 0
Infarct expansion
Timepoint [1] 365910 0
24 hours post stroke onset, using Non-contrast computed tomography (NCCT)+/- computed tomography angiography (CTA) +/- computed tomography perfusion (CTP) and/or Magnetic resonance imaging (MRI).
Secondary outcome [2] 367152 0
Haemorrhagic transformation
Timepoint [2] 367152 0
24 hour post stroke onset, that will include repeat NCCT +/- CTA +/- CTP and/or MRI.
Secondary outcome [3] 367158 0
Health related quality of life
Timepoint [3] 367158 0
90 days post stroke onset, using the EQ-5D-5L

Eligibility
Key inclusion criteria
-Patients who receive endovascular thrombectomy for ischemic stroke
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who pass away before the patient/persons responsible information statement is given.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample:
Development of a predictive model of patient outcome is based on both a set of predefined statistical hypotheses, and on the statistical considerations of model accuracy and fit. We will be using all our data for the purposes of model development and validation. It is proposed that a single predictive model will be sufficient to address the questions posed by the MOSES study by the development of a derivation and validation cohort. The pre-specified predictors that correspond to the individual research questions above which are to be included in the model development are: baseline ischemic core volume, vessel occlusion location, collateral status, patient age and premorbid health status measured by the modified Rankin score.
In the model derivation cohort, recruiting 1565 subjects would yield 80% power to detect the difference of 5% in probability of a positive outcome when the specified predictor is at the mean and at one standard deviation above the mean (for the most conservative case of the probability of 0.5), assuming the squared multiple correlation between the predictor variable and all other variables in the model of 0.6 and two-tailed significance level of 0.05. This estimation is conservative in the sense that both the probabilities that are different to 0.5 and squared multiple correlation lower than 0.6 may require smaller sample sizes. This analysis was conducted using Stata command powerlog with the options of p1=0.5, p2=0.55, R squared=0.6, and p=0.05.
The resulting predictive models will be incorporated into an imaging and clinical decision support tool that will be externally validated on 500 patients. Assuming the standard settings of Type I error alpha = 0.05, recruiting 500 patients will yield 0.9 power to observe an almost perfect agreement between the proposed method and the gold standard (kappa of 0.8 or higher) against the null hypothesis of substantial agreement (kappa of 0.6). The resulting sample size is therefore 2065.

Statistical analysis:
Using the data from the MOSES study, we will utilize a combination of contemporary statistical, machine learning, and simulation techniques (logistic regression analyses, classification and regression trees, support vector machines, Bayesian classifiers, embedded in an agent- based simulation models) that have not yet been used in this domain, to design a predictive model to estimate patient outcome from thrombectomy. There will also be a detailed health economics evaluation. Cost will be calculated using ‘pathway analysis’ with full specification of the thrombectomy procedure pathway (including cost of transfers, consumables and treatment of complications following the procedure, utilisation of critical care and ward beds), post- discharge care up to 3 months (including use of nursing home beds, informal care, home-based support services etc.) and productivity costs (arising from inability to return to work).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2065
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 12308 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 12309 0
John Hunter Hospital - New Lambton
Recruitment hospital [3] 12310 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 12311 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 24505 0
2305 - New Lambton
Recruitment postcode(s) [2] 24504 0
3050 - Parkville
Recruitment postcode(s) [3] 24507 0
3168 - Clayton
Recruitment postcode(s) [4] 24506 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 301050 0
Government body
Name [1] 301050 0
National health and medical research council program grant fund
Country [1] 301050 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
Royal Melbourne Hospital, Office for research
Level 2
South West,
300 Grattan Street,
Parkville, Victoria 3050
Country
Australia
Secondary sponsor category [1] 301418 0
None
Name [1] 301418 0
Address [1] 301418 0
Country [1] 301418 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301804 0
Hunter New England Human Research Ethics committee
Ethics committee address [1] 301804 0
Lookout Road
New Lambton NSW 2305
Ethics committee country [1] 301804 0
Australia
Date submitted for ethics approval [1] 301804 0
28/09/2018
Approval date [1] 301804 0
30/11/2018
Ethics approval number [1] 301804 0

Summary
Brief summary
Stroke affects millions of people worldwide. Endovascular treatment is an effective treatment for stroke patients with a blockage in a large brain artery. By collecting information about the brain scan changes from acute stroke patients, MOSES study aims to improve the way doctors use brain imaging in the future to guide endovascular treatment for stroke, leading to improved patient outcomes .
Research questions:
- Is there a certain volume of ischemic core (dead brain) (for example >100ml) beyond which benefits from thrombectomy are negated.
-As age increases, does pre-treatment volume of dead brain for which a favorable outcome can be achieved decline?
- Is the benefit of thrombectomy the same for distal (small) blocked arteries comparable to large blocked arteries?
- How can we more accurately predict the outcome from thrombectomy in patients who will have long transfer times to a comprehensive stroke centre?
- What is an ‘acceptable’ outcome, particularly in patients with a large volume of pre-treatment dead brain and/or premorbid disability.
- For which groups of stroke patients does thrombectomy confer good ‘value for money’?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88166 0
Prof Mark Parsons
Address 88166 0
Royal Melbourne Hospital
300 Grattan Street
Parkville, Victoria 3050
Country 88166 0
Australia
Phone 88166 0
+61 3 9342 8448
Fax 88166 0
Email 88166 0
Mark.Parsons@mh.org.au
Contact person for public queries
Name 88167 0
Andrew Bivard
Address 88167 0
Royal Melbourne Hospital
300 Grattan Street
Parkville, Victoria 3050
Country 88167 0
Australia
Phone 88167 0
+61 3 9342 4414
Fax 88167 0
Email 88167 0
andrew.bivard@hotmail.com
Contact person for scientific queries
Name 88168 0
Andrew Bivard
Address 88168 0
Royal Melbourne Hospital
300 Grattan Street
Parkville, Victoria 3050
Country 88168 0
Australia
Phone 88168 0
+61 3 9342 4414
Fax 88168 0
Email 88168 0
andrew.bivard@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study steering committee has decided the only allow access to data for study investigators who have made a substantial contribution to the study.


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.