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NCT Number: NCT06633809

Therapy Evaluation in Patients With Minor Stroke and Large Vessel Occlusion

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Xingyue Hu, Prof.

CONTACT

[email protected]

8657186006902 ext. 8657186006902

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Immediate endovascular therapy

Other

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

Other names: Best medical therapy

Primary outcomes

  1. modified Rankin Scale at 90 days

    Time frame: 90 days

    modified Rankin Scale at 90 days

  2. 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.

Secondary outcomes

  1. Incidence of symptomatic intracerebral hemorrhage

    Time frame: 2-3 days

    Incidence of symptomatic intracerebral hemorrhage according to ECASS II criteria

  2. patients with good outcome comparing the two treatment groups

    Time frame: 90 days

    Good outcome is defined as a score of 0-2 on the 90-day mRS

Sponsors and collaborators

Lead sponsor

Sir Run Run Shaw Hospital

Other

Registry information

Official study title

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

Acronym: TEMPOS

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Oct 9, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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