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Therapy Evaluation in Patients With Minor Stroke and Large Vessel Occlusion

Therapy Evaluation in Patients With Minor Stroke and Large Vessel Occlusion: A Prospective Multicenter Registry Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06633809
Acronym
TEMPOS
Enrollment
200
Registered
2024-10-09
Start date
2021-11-22
Completion date
2027-03-01
Last updated
2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Diseases, Brain Infarction, Central Nervous System Diseases, Cerebrovascular Disorders, Nervous System Diseases, Stroke, Acute, Vascular Diseases

Keywords

stroke, Mechanical thrombectomy, Proximal intracranial arterial occlusions, Large vessel occlusion, acute neurological deterioration, Outcome

Brief 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.

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.

Interventions

OTHERImmediate endovascular therapy

The best medical therapy includes intravenous fibrinolysis, anticoagulants or antiplatelet, but NOT any immediate endovascular therapies.

Sponsors

Sir Run Run Shaw Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Aged 18 years or older 2. Acute ischemic stroke patients of NIHSS 0-5 with 24 hours after onset 3. Proximal intracranial artery occlusion on NCCT/CTA or MRI/MRA showing occlusion of the intracranial ICA, M1, or proximal M2 vessel 4. Baseline ASPECTS ≥6 or infarct Core Volume of \< 70 on NCCT/DWI/CTP 5. Pre-mRS≤1

Exclusion criteria

1. Any sign of intracranial hemorrhage on baseline CT/MR; 2. Seizures at stroke onset 3. 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 4. Participation in any investigational study in the previous 30 days

Design outcomes

Primary

MeasureTime frameDescription
modified Rankin Scale at 90 days90 daysmodified Rankin Scale at 90 days
acute neurological deterioration24 hoursIt is neurological deterioration of presumed ischemic origin with an NIHSS score increase of 4 points or more within the 24 hours after onset.

Secondary

MeasureTime frameDescription
Incidence of symptomatic intracerebral hemorrhage2-3 daysIncidence of symptomatic intracerebral hemorrhage according to ECASS II criteria
patients with good outcome comparing the two treatment groups90 daysGood outcome is defined as a score of 0-2 on the 90-day mRS

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026