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

115 People's Hospital

Status

Enrolling

Conditions

Acute Ischemic Stroke

Treatments

Procedure: Endovascular treatment

Study type

Observational

Funder types

Other

Identifiers

NCT06016348

115

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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