Stroke, AcuteTEMPOSNCT06633809
Therapy Evaluation in Patients With Minor Stroke and Large Vessel Occlusion
An observational study of Stroke, Acute and Cerebrovascular Disorders, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
This multicenter registry study, which record the therapy strategy and follows up these acute ischemic stroke (AIS) patients with low NIHSS and large vessel occlusion (LVO), is intended to provide the important data for therapy evaluation and prognostic prediction of the LVO patients with low NIHSS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Cerebrovascular Disorders, Brain Diseases
- What is being tested?
- Immediate endovascular therapy
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2021to 1 Mar 2027
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Acute ischemic stroke patients with minor stroke (NIHSS 0-5) and large artery occlusion.
Who may be able to join
- Aged 18 years or older
- Acute ischemic stroke patients of NIHSS 0-5 with 24 hours after onset
- Proximal intracranial artery occlusion on NCCT/CTA or MRI/MRA showing occlusion of the intracranial ICA, M1, or proximal M2 vessel
- Baseline ASPECTS ≥6 or infarct Core Volume of < 70 on NCCT/DWI/CTP
- Pre-mRS≤1
Who cannot join
- Any sign of intracranial hemorrhage on baseline CT/MR;
- Seizures at stroke onset
- Baseline blood glucose of <2.78 mmol or >22.20 mmol, or platelet count < 100,000/uL or serum creatinine levels > 3.0 mg/dL
- Participation in any investigational study in the previous 30 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310000
Xingyue Hu, Prof., 8657186006902 ext. 8657186006902, huxingyue2003@zju.edu.cn
About this study
Official title: Therapy Evaluation in Patients With Minor Stroke and Large Vessel Occlusion: A Prospective Multicenter Registry Study
This multicenter registry study, which record the therapy strategy and follows up these acute ischemic stroke (AIS) patients with low NIHSS and large vessel occlusion (LVO), is intended to provide the important data for therapy evaluation and prognostic prediction of the LVO patients with low NIHSS.
Read the detailed description
It was reported that about two third of the stoke patients might present with minor or mild stroke symptoms. 20-40% of those minor stroke patients had large vessel occlusion (LVO). AIS patients with LVO and low NIHSS are common and has been associated with early neurological deterioration and worse outcomes. Until now, the best therapy strategy for the acute stoke patients with minor stroke and large vessel occlusion is unknown. Thus, we sought to (1) explore the potential predictors of acute neurological deterioration and 90-day clinical outcome; (2) and evaluate the best therapy strategy.
- Conditions
- Stroke, Acute, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Vascular Diseases, Brain Infarction
- Being tested
- Immediate endovascular therapy
- Keywords
- stroke, Mechanical thrombectomy, Proximal intracranial arterial occlusions, Large vessel occlusion, acute neurological deterioration, Outcome
- Medical subject headings
- Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Vascular Diseases, Brain Infarction, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate endovascular therapyOther
Also called Best medical therapy
The best medical therapy includes intravenous fibrinolysis, anticoagulants or antiplatelet, but NOT any immediate endovascular therapies.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Endovascular Therapy | The immediate endovascular therapy is performed immediately after stroke onset with any thrombectomy device usually used. Receives: Other: Immediate endovascular therapy | |
| Best Medical Therapy | The best medical therapy is standard medical therapy, including intravenous fibrinolysis, anticoagulants or antiplatelet, but NOT including any endovascular therapies. The rescue endovascular therapies may be performed in case of acute neurological deterioration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Scale at 90 days
modified Rankin Scale at 90 days
Measured: 90 days
acute neurological deterioration
It is neurological deterioration of presumed ischemic origin with an NIHSS score increase of 4 points or more within the 24 hours after onset.
Measured: 24 hours
Secondary outcomes (2)
Incidence of symptomatic intracerebral hemorrhage
Incidence of symptomatic intracerebral hemorrhage according to ECASS II criteria
Measured: 2-3 days
patients with good outcome comparing the two treatment groups
Good outcome is defined as a score of 0-2 on the 90-day mRS
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 posted9 Oct 2024
- Study start22 Nov 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinhua Zhang, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633809
- Sponsor's protocol ID
- 20210607-34
- Acronym
- TEMPOS
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy Evaluation in Patients With Minor Stroke and Large Vessel Occlusion: A Prospective Multicenter Registry Study
- ClinicalTrials.gov ID
- NCT06633809
- Acronym / sponsor ID
- TEMPOS / 20210607-34
- Conditions
- Stroke, Acute, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Vascular Diseases, Brain Infarction
- Keywords
- stroke, Mechanical thrombectomy, Proximal intracranial arterial occlusions, Large vessel occlusion, acute neurological deterioration, Outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 9 Oct 2024 (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.
This multicenter registry study, which record the therapy strategy and follows up these acute ischemic stroke (AIS) patients with low NIHSS and large vessel occlusion (LVO), is intended to provide the important data for therapy evaluation and prognostic prediction of the LVO patients with low NIHSS.
Detailed description
It was reported that about two third of the stoke patients might present with minor or mild stroke symptoms. 20-40% of those minor stroke patients had large vessel occlusion (LVO). AIS patients with LVO and low NIHSS are common and has been associated with early neurological deterioration and worse outcomes. Until now, the best therapy strategy for the acute stoke patients with minor stroke and large vessel occlusion is unknown. Thus, we sought to (1) explore the potential predictors of acute neurological deterioration and 90-day clinical outcome; (2) and evaluate the best therapy strategy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Endovascular Therapy | – | Other: Immediate endovascular therapyThe immediate endovascular therapy is performed immediately after stroke onset with any thrombectomy device usually used. |
| Best Medical Therapy | – | –The best medical therapy is standard medical therapy, including intravenous fibrinolysis, anticoagulants or antiplatelet, but NOT including any endovascular therapies. The rescue endovascular therapies may be performed in case of acute neurological deterioration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute ischemic stroke patients with minor stroke (NIHSS 0-5) and large artery occlusion.
Key inclusion criteria (5 listed)
- Aged 18 years or older
- Acute ischemic stroke patients of NIHSS 0-5 with 24 hours after onset
- Proximal intracranial artery occlusion on NCCT/CTA or MRI/MRA showing occlusion of the intracranial ICA, M1, or proximal M2 vessel
- Baseline ASPECTS ≥6 or infarct Core Volume of < 70 on NCCT/DWI/CTP
- Pre-mRS≤1
Key exclusion criteria (4 listed)
- Any sign of intracranial hemorrhage on baseline CT/MR;
- Seizures at stroke onset
- Baseline blood glucose of <2.78 mmol or >22.20 mmol, or platelet count < 100,000/uL or serum creatinine levels > 3.0 mg/dL
- Participation in any investigational study in the previous 30 days
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 |
|---|---|---|
| Immediate endovascular therapyAlso: Best medical therapyThe best medical therapy includes intravenous fibrinolysis, anticoagulants or antiplatelet, but NOT any immediate endovascular therapies. | Other | Immediate Endovascular Therapy |
Primary outcome
modified Rankin Scale at 90 days
Time frame: 90 days
modified Rankin Scale at 90 days
acute neurological deterioration
Time frame: 24 hours
It is neurological deterioration of presumed ischemic origin with an NIHSS score increase of 4 points or more within the 24 hours after onset.
2 secondary outcomes
Incidence of symptomatic intracerebral hemorrhage
Time frame: 2-3 days
patients with good outcome comparing the two treatment groups
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute and Cerebrovascular Disorders, run by Sir Run Run Shaw Hospital 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 9 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale at 90 days (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2024; AzTrials last refreshed its copy on 26 Oct 2026.