Ischemic StrokeHOPES2NCT03744533
Head-down Position for Acute Ischemic Stroke With Large Artery Atherosclerosis
A study testing head-down position treatment and guideline-based treatment in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
Currently, the guideline recommended re-perfusion such as intravenous thrombolysis and mechanical thrombectomy as the most effective treatment for acute ischemic stroke. However, the two methods are restricted by a strict time window, which greatly limits the number of the patients receiving treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- head-down position treatment and guideline-based treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2018to 28 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age over 18 years
- acute ischemic stroke within 24 h of onset
- neurological deficit: 6≤NIHSS≤16
- Large artery atherosclerosis etiology based on TOAST typing
- the supplied vessel is the middle cerebral artery or internal carotid artery, and the degree of stenosis was more than 50%.
- first stroke onset or past stroke without obvious neurological deficit (mRS≤1)
- Signed informed consent
Who cannot join
- Disturbance of consciousness
- Hemorrhagic stroke or mixed stroke
- Combining with severe organ dysfunction
- Past hemorrhagic stroke
- A history of stroke with severe sequelae
- Planned revascularization within 3 months
Show all 10Show fewer
- Ischemic stroke due to surgical intervention
- participating in other clinical trials within 3 months
- Pregnant or lactating women
- any inappropriate patient assessed by the researcher
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Head-down Position for Acute Ischemic Stroke With Large Artery Atherosclerosis: a Prospective, Random, Multi-Center, Pilot Trial
Currently, the guideline recommended re-perfusion such as intravenous thrombolysis and mechanical thrombectomy as the most effective treatment for acute ischemic stroke. However, the two methods are restricted by a strict time window, which greatly limits the number of the patients receiving treatment. The abundant studies have suggested that good collateral circulation can provide compensatory blood supply to save the ischemic penumbra and reduces the infarct volume, which improves the prognosis. How to improve collateral circulation in an efficient and safe way is a clinical challenge. Our recent experiment results of the animal and preliminary clinical experiments show that head-down position may significantly increase cerebral perfusion and improve neurological function. Clinically, head-down position is simple and easy to operate, and theoretically may increases brain perfusion and improve collateral circulation. A pilot randomized clinical trial is designed to investigate the effect of head-down position combined with routine rehabilitation in patients with ischemic stroke.The study is designed to explore the efficacy and safety of head-down position in patients with acute ischemic stroke
- Conditions
- Ischemic Stroke
- Being tested
- head-down position treatment, guideline-based treatment
- Keywords
- head-down position, Large Artery Atherosclerosis
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
head-down position treatmentOther
the head position of subjects is lowered to 20 degrees in a supine position between 8:00-22:00 within 24h post-randomization as long as possible. During the procedure, when subjects feel intolerable, the head position will be elevated to lying flat (0 degree) for 5-10min, and then the above procedure is repeated. After 24h post-randomization, the head down procedures with -20 degrees in a supine position with duration of 1-1.5 hour will be performed three times daily at 9:00-11:00, 15:00-17:00 and 20:00-22:00, respectively.
guideline-based treatmentOther
guideline-based treatment
| Study group | Role | What they receive |
|---|---|---|
| head-down position treatment | Experimental | Not described Receives: Other: head-down position treatment; Other: guideline-based treatment |
| guideline-based treatment | Active comparator | Not described Receives: Other: guideline-based treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of modified Rankin Score of 0 to 2
Measured: 90 days
Secondary outcomes (4)
Proportion of modified Rankin Score of 0 to 1
Measured: 90 days
proportion of early neurological deterioration
Early neurological deterioration, defined as more than 4 increase in National Institute of Health stroke scale score
Measured: 48 hours
The occurence of stroke or other vascular events
Measured: 90 days
proportion of death of any cause
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start26 Nov 2018
- Primary completion28 Aug 2021
- Study completion28 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
- Investigators
- Huisheng Chen, Doctor, Study chair, Neurology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744533
- Sponsor's protocol ID
- k （2018）38
- Acronym
- HOPES2
- Status last verified
- Sep 2021
- First submitted
- 14 Nov 2018
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen HS, Zhang NN, Cui Y, Li XQ, Zhou CS, Ma YT, Zhang H, Jiang CH, Li RH, Wan LS, Jiao Z, Xiao HB, Li Z, Yan TG, Wang DL, Nguyen TN. A randomized trial of Trendelenburg position for acute moderate ischemic stroke. Nat Commun. 2023 May 5;14(1):2592. doi: 10.1038/s41467-023-38313-y.
PubMed 37147320
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head-down Position for Acute Ischemic Stroke With Large Artery Atherosclerosis: a Prospective, Random, Multi-Center, Pilot Trial
- ClinicalTrials.gov ID
- NCT03744533
- Acronym / sponsor ID
- HOPES2 / k （2018）38
- Conditions
- Ischemic Stroke
- Keywords
- head-down position, Large Artery Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 28 Aug 2021 (actual)
- Study completion
- 28 Aug 2021 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, the guideline recommended re-perfusion such as intravenous thrombolysis and mechanical thrombectomy as the most effective treatment for acute ischemic stroke. However, the two methods are restricted by a strict time window, which greatly limits the number of the patients receiving treatment. The abundant studies have suggested that good collateral circulation can provide compensatory blood supply to save the ischemic penumbra and reduces the infarct volume, which improves the prognosis. How to improve collateral circulation in an efficient and safe way is a clinical challenge. Our recent experiment results of the animal and preliminary clinical experiments show that head-down position may significantly increase cerebral perfusion and improve neurological function. Clinically, head-down position is simple and easy to operate, and theoretically may increases brain perfusion and improve collateral circulation. A pilot randomized clinical trial is designed to investigate the effect of head-down position combined with routine rehabilitation in patients with ischemic stroke.The study is designed to explore the efficacy and safety of head-down position in patients with acute ischemic stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| head-down position treatment | Experimental | Other: head-down position treatment, Other: guideline-based treatment |
| guideline-based treatment | Active comparator | Other: guideline-based treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient age over 18 years
- acute ischemic stroke within 24 h of onset
- neurological deficit: 6≤NIHSS≤16
- Large artery atherosclerosis etiology based on TOAST typing
- the supplied vessel is the middle cerebral artery or internal carotid artery, and the degree of stenosis was more than 50%.
Key exclusion criteria (10 listed)
- Disturbance of consciousness
- Hemorrhagic stroke or mixed stroke
- Combining with severe organ dysfunction
- Past hemorrhagic stroke
- A history of stroke with severe sequelae
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| head-down position treatmentthe head position of subjects is lowered to 20 degrees in a supine position between 8:00-22:00 within 24h post-randomization as long as possible. During the procedure, when subjects feel intolerable, the head position will be elevated to lying flat (0 degree) for 5-10min, and then the above procedure is repeated. After 24h post-randomization, the head down procedures with -20 degrees in a supine position with duration of 1-1.5 hour will be performed three times daily at 9:00-11:00, 15:00-17:00 and 20:00-22:00, respectively. | Other | head-down position treatment |
| guideline-based treatmentguideline-based treatment | Other | guideline-based treatment, head-down position treatment |
Primary outcome
proportion of modified Rankin Score of 0 to 2
Time frame: 90 days
4 secondary outcomes
Proportion of modified Rankin Score of 0 to 1
Time frame: 90 days
proportion of early neurological deterioration
Time frame: 48 hours
The occurence of stroke or other vascular events
Time frame: 90 days
proportion of death of any cause
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Derived from this study: PubMed 37147320Chen HS, Zhang NN, Cui Y, Li XQ, Zhou CS, Ma YT, Zhang H, Jiang CH, Li RH, Wan LS, Jiao Z, Xiao HB, Li Z, Yan TG, Wang DL, Nguyen TN. A randomized trial of Trendelenburg position for acute moderate ischemic stroke. Nat Commun. 2023 May 5;14(1):2592. doi: 10.1038/s41467-023-38313-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huisheng Chen, Doctor study chair
Neurology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing head-down position treatment and guideline-based treatment in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of modified Rankin Score of 0 to 2 (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03744533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.