PROMISE: PRedictors Of Good outcoMes in Thrombectomy for Large Infarct Core Stroke Evaluation

Recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Procedure: Endovascular treatment

• Registration Number: NCT06016348
• Lead Sponsor: 115 People's Hospital

Brief Summary

Identify the factors associated with a favorable clinical outcome in participants with acute ischemic stroke and large core infarcts within 24 hours of onset who are treated with endovascular intervention.

Detailed Description

In 2022 and early 2023, three randomized controlled trials-RESCUE-JAPAN LIMIT, SELECT 2, and ANGEL ASPECT-were published in the New England Journal of Medicine. These trials demonstrated the effectiveness and safety of endovascular intervention using clot retrieval devices in participants with acute ischemic stroke and large core infarcts. However, the rate of participants achieving a good recovery remains low, while the mortality and disability rates are very high.

Moreover, in Vietnam, the acute stroke treatment process has not been optimized, and the facilities and equipment for monitoring neurointensive care are not fully equipped. As a result, endovascular intervention using clot retrieval devices in participants with large core infarcts has not been widely implemented in the investigator's country, and the effectiveness and safety of this treatment method have not been clearly evaluated.

Addressing this issue is crucial for improving the quality of life and reducing the mortality and disability rates caused by stroke in this participant group. This study aims to provide new insights into the use of endovascular intervention for treating acute ischemic stroke with a large core infarct volume, thereby supporting clinical decision-making and improving treatment outcomes for participants with acute ischemic stroke and large core infarcts.

We hypothesize that core infarction is not the sole factor for excluding patients from potent thrombectomy therapy. We aim to determine predictors of favorable and unfavorable outcomes following thrombectomy in patients with large core strokes. Secondly, we aim to build a multivariable calculator to predict good or poor outcomes after thrombectomy.

Study Timeline

• Study Start: 2023-07-28
• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-08-26
• Study First Posted: 2023-08-29
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-25
• Last Update Posted: 2024-01-02
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Age ≥ 18-year-old

• Patients presenting with acute ischaemic stroke within 24 hours of stroke onset

• Received mechanical thrombectomy within 24 hours of stroke onset

• Imaging criteria include:

  • Large vessel occlusion on CT Angiography or MR Angiography (MRA) including tandem occlusion of the internal carotid artery and middle cerebral artery or internal carotid artery.

  • Core infarct criteria:

    1. ASPECTS ≤5 on non-contrast CT or diffusion-weighted imaging (DWI).
    2. ASPECTS score >5 and core infarct volume of 50-150 ml on CT perfusion (CTP) or reduced cerebral blood flow (rCBF) <30% on CTP or apparent diffusion coefficient (ADC) <620 × 10-6 mm2/s on DWI.

Exclusion Criteria

• Patients presenting with acute ischaemic stroke >24 hours of stroke onset
• Intracranial hemorrhage identified by CT or MRI
• Pre-stroke modified Rankin Score (mRS) score of >2 (indicating previous disability)
• Any terminal illness such that the patient has a life expectancy of less than 1 year.
• Patients with active cancer and undergoing treatment for cancer are excluded,
• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Good outcome	Endovascular treatment	mRS of 0-3; mRS of 0-2
Unfavorable outcomes	Endovascular treatment	mRS of 4-6

Primary Outcome Measures

Name	Time	Method
The Modified Rankin Scale (mRS) of 0-3	90 (± 14 days) after procedure	The rate of independent ambulation (mRS 0-3). The scale runs from 0-6, running from perfect health without symptoms to death.

Secondary Outcome Measures

Name	Time	Method
mRS of 0-5	90 (± 14 days) after procedure	The survival rate
mRS of 0-2	90 (± 14 days) after procedure	The rate of functional independence (mRS 0-2)
Early neurological deterioration	72 hours	Clinical worsening that was higher by ≥4 points than the value at baseline during the first 72 h after ischaemic stroke.
Symptomatic intracerebral hemorrhage (sICH)	72 hours	sICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 72 hours or any hemorrhage leading to death.

Trial Locations

Locations (4)

Can Tho Central General Hospital; 🇻🇳 Cần Thơ, Vietnam

University Medical Center; 🇻🇳 Ho Chi Minh City, Vietnam

Da Nang Stroke Center; 🇻🇳 Da Nang, Vietnam

115 PEOPLE's HOSPITAL; 🇻🇳 Ho Chi Minh City, Vietnam