Therapy Evaluation in Patients With Minor Stroke and Large Vessel Occlusion (TEMPOS)

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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Infarction; Stroke, Acute
• Intervention / Treatment: Other: Immediate endovascular therapy

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Sir Run Run Shaw Hospital
      • Contact: Xingyue Hu, Prof.; Phone Number: 8657186006902 8657186006902; Email: huxingyue2003@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Acute ischemic stroke patients with minor stroke (NIHSS 0-5) and large artery occlusion.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Immediate Endovascular Therapy; The immediate endovascular therapy is performed immediately after stroke onset with any thrombectomy device usually used.	Other: Immediate endovascular therapy; The best medical therapy includes intravenous fibrinolysis, anticoagulants or antiplatelet, but NOT any immediate endovascular therapies.; Other Names: Best medical 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
modified Rankin Scale at 90 days	modified Rankin Scale at 90 days	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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of symptomatic intracerebral hemorrhage	Incidence of symptomatic intracerebral hemorrhage according to ECASS II criteria	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	90 days

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Estimated): October 9, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: stroke; Outcome; Large vessel occlusion; Mechanical thrombectomy; Proximal intracranial arterial occlusions; acute neurological deterioration
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Brain Ischemia; Infarction; Stroke; Vascular Diseases; Nervous System Diseases; Brain Diseases; Cerebrovascular Disorders; Brain Infarction; Central Nervous System Diseases
• Other Study ID Numbers: 20210607-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No