Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000599875
Ethics application status
Approved
Date submitted
10/02/2021
Date registered
20/05/2021
Date last updated
23/06/2024
Date data sharing statement initially provided
20/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Adelaide Stroke Incidence Study - 2
Scientific title
Adelaide Stroke Incidence Study -2: A Gold-Standard, Population Based, prospective stroke incidence study.
Secondary ID [1] 303400 0
None
Universal Trial Number (UTN)
U1111-1264-8110
Trial acronym
ASCEND-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic stroke 320685 0
Intracerebral Haemorrhage 320686 0
Non-traumatic Subarachnoid haemorrhage 320687 0
Transent ischemic Attack 320688 0
Condition category
Condition code
Stroke 318531 318531 0 0
Ischaemic
Stroke 318532 318532 0 0
Haemorrhagic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients who present with new onset ischemic stroke, transient ischemic attack (TIA), intracerebral haemorrhage or non-traumatic subarachnoid haemorrhage will be recruited prospectively and followed up at 3 months, and 12 months.

At baseline:
• Demographic Data
• Stroke history: onset date, symptoms, presentation;
• Past Medical History and known risk factors, prior medications, adherence to primary prevention;
• General health and wellbeing prior to the stroke including pre-stroke mRS
• Diagnostic tests and their results: radiology; bloods and cardiology results;
• Treatments: emergency treatment and management of symptoms;
• Availability of allied health treatments: physiotherapy/occupational therapy/dietetics; and
• Discharge plan: referral to rehabilitation/care packages/accommodation requirements/ medications

At 3 months and 12 months:
• Blood pressure (3 months only)
• Quality of life (Euro-QOL 5D)
• Stroke impact and recovery (modified rankin scale)
• Control of secondary risk factors
• Adherence to medication
• Cognitive impairment (three months only) (utilising the Montreal Cognitive Assessment, MOCA)
• Financial impact to patient and community (time spent in hospital, change in employment status, time spent at home)
• Health service utilisation.

Intervention code [1] 319705 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326487 0
Incidence of 'first ever' stroke per 100, 000 people in the Western Suburbs of Adelaide prospectively ascertained using patient hospital presentations, outpatient clinic presentations and patient medical records.
Timepoint [1] 326487 0
Baseline
Secondary outcome [1] 391654 0
Stroke recurrence rates of patients with 'first ever' stroke utilising medical records and study questionnaire during follow up.
Timepoint [1] 391654 0
at 3 months post baseline and 12 months post baseline.
Secondary outcome [2] 391656 0
Stroke subtype incidence from presentations, patient records and etiological work up.
Timepoint [2] 391656 0
At baseline, 3 months post baseline and 12 months post baseline.
Secondary outcome [3] 391657 0
Prevalence of migraine-aura like as a presenting symptom of an acute stroke, assessed during clinical examination.
Timepoint [3] 391657 0
At baseline
Secondary outcome [4] 391662 0
Prevalence of symptomatic-nonstenotic carotid artery disease (SynC) in the embolic stroke of undetermined source (ESUS) cohort based on medical imaging and clinical presentation.
Timepoint [4] 391662 0
At baseline, 3 months post baseline and 12 months post baseline.
Secondary outcome [5] 391664 0
Mortality rate from first ever stroke presentation in the sampled population using data-linkage to clinical records, family interviews, and death registry audit
Timepoint [5] 391664 0
At baseline, 3 months post baseline and 12 months post baseline.
Secondary outcome [6] 391666 0
Investigate long term medication adherence utilising study specific questionnaire.
Timepoint [6] 391666 0
At 3 months post baseline and 12 months post baseline.
Secondary outcome [7] 391669 0
Prevalence of patent foramen oval (PFO) in elderly patients (>60 years) with stroke assessed by trans-thoracic echocardiogram.
Timepoint [7] 391669 0
at baseline and 3 months post baseline.
Secondary outcome [8] 391670 0
Prevalence of of clonal hematopoiesis of indeterminate potential (CHIP) in elderly patients with stroke assessed by blood testing.
Timepoint [8] 391670 0
at baseline
Secondary outcome [9] 394166 0
Incidence of stroke risk factor profiles from clinical history, examination and study questionnaire
Timepoint [9] 394166 0
At baseline
Secondary outcome [10] 395511 0
Blood pressure control measured using sphygmomanometer at clinical review 3 months post stroke. If face-to face interview prohibited, last blood pressure measured by general practitioner will be utilised.
Timepoint [10] 395511 0
At 3 months post-baseline.
Secondary outcome [11] 395512 0
Quality of Life (Euro-QOL 5D) score at 3 and 12 month review using questionnaire.
Timepoint [11] 395512 0
At 3 and 12 months post-baseline.
Secondary outcome [12] 395513 0
Modified Rankin score (mRS) measure at baseline, 3 and 12 months post stroke.
Timepoint [12] 395513 0
At baseline, 3 months post-baseline and 12 months post-baseline
Secondary outcome [13] 395514 0
Cognitive function utilising the Montreal Cognitive Assessment (MOCA) at 3 months post stroke.
Timepoint [13] 395514 0
At 3 months post-baseline.
Secondary outcome [14] 395515 0
Financial impact to patient and family due time away from work and change in employment status assessed by interview and study-specific questionnaire data collection sheet.
Timepoint [14] 395515 0
baseline, 3 months post-baseline and 12 months post-baseline.
Secondary outcome [15] 395516 0
Adherence to stroke secondary prevention medications based on clinical interview (documented in 3 and 12 month study data collection sheets) at 3 and 12 month study follow up.
Timepoint [15] 395516 0
3 months and 12 months post-baseline
Secondary outcome [16] 395517 0
Health service utilisation assessed using time in acute hospital, time in rehab and time needing rehab at home services recorded in study-specific questionnaire during follow up interviews.
Timepoint [16] 395517 0
At 3 months and 12 months post-baseline.

Eligibility
Key inclusion criteria
1. Patients presenting with acute neurological symptoms of potential cerebrovascular aetiology within pre-defined postcodes, over a defined 24 month period.
2. Age greater than or equal to 18 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age < 18 years
2. Brain masses/tumours/structural lesions
3. Subdural and extradural hemorrhage
4. Traumatic SAH
5. Other mimics including post seizure palsies, hypoglycemia, metabolic derangement, functional neurological disorders, etc

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Incidence rates (first-ever) and attack rates (all strokes) will be calculated per 100,000 per year with confidence intervals (CIs) calculated from the Poisson distribution. Rates were standardized to the world population to allow interstudy comparisons. Data will be reported with 95% CI.

A comparison of the TOAST, ASCOD and CCD criteria will be made to evaluate the inter -classification variability and accuracy. The authors impression of the diagnostic aetiology will be compared to formal coding documentation to assess the accuracy of formal documentation.

Prevalence of SyNC will be determined as a proportion of the ESUS patient cohort will be identified. The rate of presentation of stroke with migraine-aura like symptoms will be identified, and prevalence of these symptoms based on site of stroke will be identified in the population

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
11/01/2021
Date of last participant enrolment
Anticipated
11/01/2023
Actual
11/01/2023
Date of last data collection
Anticipated
11/10/2024
Actual
Sample size
Target
800
Accrual to date
Final
710
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 18660 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 18661 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [3] 18662 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [4] 18663 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 33031 0
5007 - Bowden
Recruitment postcode(s) [2] 33032 0
5007 - Brompton
Recruitment postcode(s) [3] 33033 0
5007 - Hindmarsh
Recruitment postcode(s) [4] 33034 0
5007 - Welland
Recruitment postcode(s) [5] 33035 0
5007 - West Hindmarsh
Recruitment postcode(s) [6] 33036 0
5008 - Croydon
Recruitment postcode(s) [7] 33037 0
5008 - Croydon Park
Recruitment postcode(s) [8] 33038 0
5008 - Croydon Park South
Recruitment postcode(s) [9] 33039 0
5008 - Devon Park
Recruitment postcode(s) [10] 33040 0
5008 - Dudley Park
Recruitment postcode(s) [11] 33041 0
5008 - Renown Park
Recruitment postcode(s) [12] 33042 0
5008 - Ridleyton
Recruitment postcode(s) [13] 33043 0
5008 - West Croydon
Recruitment postcode(s) [14] 33044 0
5009 - Allenby Gardens
Recruitment postcode(s) [15] 33045 0
5009 - Beverley
Recruitment postcode(s) [16] 33046 0
5009 - Kilkenny
Recruitment postcode(s) [17] 33047 0
5010 - Angle Park
Recruitment postcode(s) [18] 33048 0
5010 - Ferryden Park
Recruitment postcode(s) [19] 33049 0
5010 - Regency Park
Recruitment postcode(s) [20] 33050 0
5010 - Regency Park Bc
Recruitment postcode(s) [21] 33051 0
5011 - Woodville
Recruitment postcode(s) [22] 33052 0
5011 - Woodville Park
Recruitment postcode(s) [23] 33053 0
5011 - Woodville South
Recruitment postcode(s) [24] 33054 0
5011 - Woodville West
Recruitment postcode(s) [25] 33055 0
5012 - Athol Park
Recruitment postcode(s) [26] 33056 0
5012 - Mansfield Park
Recruitment postcode(s) [27] 33057 0
5012 - Woodville Gardens
Recruitment postcode(s) [28] 33058 0
5012 - Woodville North
Recruitment postcode(s) [29] 33059 0
5013 - Gillman
Recruitment postcode(s) [30] 33060 0
5013 - Ottoway
Recruitment postcode(s) [31] 33061 0
5013 - Pennington
Recruitment postcode(s) [32] 33062 0
5013 - Rosewater
Recruitment postcode(s) [33] 33063 0
5013 - Rosewater East
Recruitment postcode(s) [34] 33064 0
5013 - Wingfield
Recruitment postcode(s) [35] 33065 0
5014 - Albert Park
Recruitment postcode(s) [36] 33066 0
5014 - Alberton
Recruitment postcode(s) [37] 33067 0
5014 - Cheltenham
Recruitment postcode(s) [38] 33068 0
5014 - Hendon
Recruitment postcode(s) [39] 33069 0
5014 - Queenstown
Recruitment postcode(s) [40] 33070 0
5014 - Royal Park
Recruitment postcode(s) [41] 33071 0
5015 - Birkenhead
Recruitment postcode(s) [42] 33072 0
5015 - Ethelton
Recruitment postcode(s) [43] 33073 0
5015 - Glanville
Recruitment postcode(s) [44] 33074 0
5015 - New Port
Recruitment postcode(s) [45] 33075 0
5015 - Port Adelaide
Recruitment postcode(s) [46] 33076 0
5016 - Largs Bay
Recruitment postcode(s) [47] 33077 0
5016 - Largs North
Recruitment postcode(s) [48] 33078 0
5016 - Peterhead
Recruitment postcode(s) [49] 33079 0
5017 - Osborne
Recruitment postcode(s) [50] 33080 0
5017 - Taperoo
Recruitment postcode(s) [51] 33081 0
5018 - North Haven
Recruitment postcode(s) [52] 33082 0
5018 - Outer Harbor
Recruitment postcode(s) [53] 33083 0
5019 - Exeter
Recruitment postcode(s) [54] 33084 0
5019 - Semaphore
Recruitment postcode(s) [55] 33085 0
5019 - Semaphore Park
Recruitment postcode(s) [56] 33086 0
5019 - Semaphore South
Recruitment postcode(s) [57] 33087 0
5020 - West Lakes Shore
Recruitment postcode(s) [58] 33088 0
5021 - West Lakes
Recruitment postcode(s) [59] 33089 0
5022 - Grange
Recruitment postcode(s) [60] 33090 0
5022 - Henley Beach
Recruitment postcode(s) [61] 33091 0
5022 - Henley Beach South
Recruitment postcode(s) [62] 33092 0
5022 - Kirkcaldy
Recruitment postcode(s) [63] 33093 0
5022 - Tennyson
Recruitment postcode(s) [64] 33094 0
5023 - Findon
Recruitment postcode(s) [65] 33095 0
5023 - Seaton
Recruitment postcode(s) [66] 33096 0
5023 - Seaton North
Recruitment postcode(s) [67] 33097 0
5024 - Fulham
Recruitment postcode(s) [68] 33098 0
5024 - Fulham Gardens
Recruitment postcode(s) [69] 33099 0
5024 - West Beach
Recruitment postcode(s) [70] 33100 0
5025 - Flinders Park
Recruitment postcode(s) [71] 33101 0
5025 - Kidman Park

Funding & Sponsors
Funding source category [1] 307816 0
Charities/Societies/Foundations
Name [1] 307816 0
The Hospital Research Foundation Group - Cure For Stroke
Country [1] 307816 0
Australia
Funding source category [2] 307828 0
Government body
Name [2] 307828 0
STOP-STROKE Synergy Grant (Number 1182071) National Health and Medical Research Council (NHMRC)
Country [2] 307828 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
1, Port Road,
Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 308522 0
None
Name [1] 308522 0
Address [1] 308522 0
Country [1] 308522 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307822 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 307822 0
Ethics committee country [1] 307822 0
Australia
Date submitted for ethics approval [1] 307822 0
25/05/2020
Approval date [1] 307822 0
24/11/2020
Ethics approval number [1] 307822 0
13614

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108622 0
Dr Joshua Mahadevan
Address 108622 0
Department of Neurology
Royal Adelaide Hospital
1, Port Road,
Adelaide, SA 5000
Country 108622 0
Australia
Phone 108622 0
+61421793074
Fax 108622 0
Email 108622 0
[email protected]
Contact person for public queries
Name 108623 0
Joshua Mahadevan
Address 108623 0
Department of Neurology
Royal Adelaide Hospital
1, Port Road,
Adelaide, SA 5000
Country 108623 0
Australia
Phone 108623 0
+61421793074
Fax 108623 0
Email 108623 0
[email protected]
Contact person for scientific queries
Name 108624 0
Joshua Mahadevan
Address 108624 0
Department of Neurology
Royal Adelaide Hospital
1, Port Road,
Adelaide, SA 5000
Country 108624 0
Australia
Phone 108624 0
+61421793074
Fax 108624 0
Email 108624 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Clinical, demographic, treatment and outcome data.
When will data be available (start and end dates)?
11/1/2022 to 11/1/2032
Available to whom?
Interested researchers
Available for what types of analyses?
Further population studies, meta-analyses.
How or where can data be obtained?
Access subject to approvals by Principal Investigator, ethical approval and a signed data access agreement. Principal investigator is reachable via email at: [email protected]


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.