Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001159549
Ethics application status
Approved
Date submitted
21/08/2015
Date registered
30/10/2015
Date last updated
30/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cerebral Haemodynamics and Orthostatic Response to Upright position in acute ischaemic Stroke (CHORUS)
Scientific title
Cerebral Haemodynamic and Orthosatics Response, in response to Upright Positioning compared to lying flat, for acute ischemic anterior circulation stroke patients with and without occlusion
Secondary ID [1] 287330 0
Nil
Universal Trial Number (UTN)
Trial acronym
CHORUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior circulation Ischemic stroke 295969 0
Condition category
Condition code
Stroke 296250 296250 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Upright positioning.
Within 24-48 hours from stroke onset, patients will be moved from a lying flat position to 4 different upright positions with data recorded at each position. The positions will be: head of the bed raised to 30 degrees, head of the bed raised to 70 degrees, 90 degrees sitting (patient sitting unassisted on edge of the bed), and 90 degrees standing. At each position, there is a period of rest (during which no data recorded) followed by 2 minutes of data collection (1 minute of ultrasound recording, followed by approximately 1 minute for collection of other outcomes). The rest period for each position are as follows: one minute after being moved to 30 degrees and 70 degrees, and 10 minutes rest after being moved to 90 degrees sitting. No rest period after being moved to standing position. Degrees will be achieved using a protractor attached to the bed. The protocol will be implemented by 2 researchers.
Intervention code [1] 292649 0
Treatment: Other
Comparator / control treatment
Lying flat.
The primary comparator will be the lying flat position. All patients will be tested at all positions (as described above), starting with the lying flat position.
Control group
Active

Outcomes
Primary outcome [1] 295907 0
Change in mean cerebral blood flow velocity between lying flat and sitting at 90 degrees. This will be assessed using bilateral transcranial doppler ultrasound.
Timepoint [1] 295907 0
Patients are tested within 48 hours of stroke. There will be 10 minutes of rest at the 90 degrees position, followed by 30 seconds of data recording.
Secondary outcome [1] 316907 0
Safety: proportion of patients with a greater than 50% drop in mean Middle Cerebral Artery velocity relative to baseline (as seen of the Transcranial dopplar ultrasound during testing) or a greater than 2 point increase in scores on the NIHSS items 1, 7, 8 or 13 (conciousness, speech, affected arm). Drops in Middle Cerebral Artery velocity will be monitored on the transcranial doppler ultrasound.
Timepoint [1] 316907 0
Patients are tested within 48 hours of stroke. Safety outcomes will be monitored during the full protocol (which takes approximately 30 minutes)
Secondary outcome [2] 316911 0
Difference in the change in mean cerebral blood flow velocity from 0 degrees lying to 90 degrees sitting, between 24-48 hours and 7 days post stroke. Middle Cerebral Artery velocity will be recorded with transcranial doppler ultrasound.
Timepoint [2] 316911 0
A comparison between data recorded at 24-48 hour and 7 day post stroke

Eligibility
Key inclusion criteria
- 18 years or older
- First or recurrent acute anterior circulation ischaemic stroke
- Recruitment within 48 hours of symptom onset
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Cerebral haemorrhage as seen on non-contrast CT
- Milignant middle cerebral artery stroke or posterior circulation ischaemia
- significant premorbid disability (modified rankin score greater than 3)
- unabele o lie flat
- Pregnant
- serious co-morbid illness
- autonomic neuropathy or any concomitant neurodegenerative disorders
- poor acoustic temporal windows

Study design
Purpose of the study
Treatment
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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Within sample design, all patients tested at all positions
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
H1 – We will use a linear regression analysis to examine the difference in response of patients with and without persistent occlusion on moving from 0 degrees to 90 degrees, with change in CBFVmean in the affected hemisphere as an outcome variable, and group and the corresponding change in the contralateral hemisphere as covariants.
H2 – We will use a random effect repeated measures linear regression to examine change in CBFVmean (moving from 0 degrees to 90 degrees) over time. In this analysis change (0-90 degrees) in the affected hemisphere will be an outcome variable, and the time point (24-48hrs vs. 7 days) and the change in the contralateral hemisphere as covariants, with patient as a random effect.
H3 – In this exploratory analysis we will examine the association between CBFVmean and incremental changes in head position (0 degrees, 30 degrees, 70 degrees, 90 degrees, standing) at 24-48 hours post-stroke using a random effects repeated measures analysis with angle as the outcome variable and change in the contralateral hemisphere as a covariant.

Determining sample size: The recent systematic review of TCD in acute stroke found a significant increase in mean flow velocity of 8.3cm/s as patients with vessel occlusion moved from 30 degrees to flat in the affected hemisphere. We aim to detect differences between baseline CBFVmean (0 degrees) and sitting CBFVmean (90 degrees) at 24 hours in patients with vessel occlusion (Primary aim). If we assume that patients without vessel occlusion have no change in CBFV (reasonable based on previous studies), then, to detect a difference in CBFVmean of 8.3 cm/s or greater with a probability of 80 percent (power) when testing at a 2 sided significance level of 5 percent a sample size of 31 patients per group (n=62) is required (H1).
To detect a change in CBFVmean over time (24 hours vs. 3-7 days post-stroke) in patients with persistent vessel occlusion the following assumptions were made. Assuming that the correlation between CBFVmean between 24 hours and 3-7 days is 0.4 or above, using a matched two tailed t-test, a probability of 80 percent (power) and a significance level of 5 percent, a sample size of 68 is required.
In total, therefore, we require 68 patients with persistent vessel occlusion and a further 31 patients without persistent vessel occlusion (n=99).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
99
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4259 0
Austin Health - Austin Hospital - Heidelberg

Funding & Sponsors
Funding source category [1] 291892 0
Self funded/Unfunded
Name [1] 291892 0
Country [1] 291892 0
Primary sponsor type
Other Collaborative groups
Name
Florey Institute of Neuroscience and Mental Health
Address
The Melbourne Brain Center,
245 Burgundy st, Heidelberg, VIC, 3084
Country
Australia
Secondary sponsor category [1] 290559 0
None
Name [1] 290559 0
Address [1] 290559 0
Country [1] 290559 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293401 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 293401 0
Ethics committee country [1] 293401 0
Australia
Date submitted for ethics approval [1] 293401 0
Approval date [1] 293401 0
23/04/2015
Ethics approval number [1] 293401 0
HREC/15/Austin/34

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

Contacts
Principal investigator
Name 59738 0
Prof Julie Bernhardt
Address 59738 0
The Florey Institute of Neuroscience and Mental Health
The Melbourne Brain Center
245 Burgundy st Heidbelberg
Victoria, 3084
Country 59738 0
Australia
Phone 59738 0
+61 3 90357072
Fax 59738 0
Email 59738 0
[email protected]
Contact person for public queries
Name 59739 0
Julie Bernhardt
Address 59739 0
The Florey Institute of Neuroscience and Mental Health
The Melbourne Brain Center
245 Burgundy st Heidbelberg
Victoria, 3084
Country 59739 0
Australia
Phone 59739 0
+61 3 90357072
Fax 59739 0
Email 59739 0
[email protected]
Contact person for scientific queries
Name 59740 0
Julie Bernhardt
Address 59740 0
The Florey Institute of Neuroscience and Mental Health
The Melbourne Brain Center
245 Burgundy st Heidbelberg
Victoria, 3084
Country 59740 0
Australia
Phone 59740 0
+61 3 90357072
Fax 59740 0
Email 59740 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

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