Clinical trial NCT06016348: PROMISE: PRedictors Of Good outcoMes in Thrombectomy for Large Infarct Core Stroke Evaluation
Official title: Predictors of Good Outcomes in Thrombectomy for Stroke Patients Within 24 Hours From Symptom Onset With Large Infarct Core
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Ischemic Stroke
Keywords: large core
Low ASPECTS
Endovascular treatment
Lead sponsor: 115 People's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Medicine and Pharmacy at Ho Chi Minh City
First posted: 2023-08-29
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients underwent mechanical thrombectomy within 24 hours from symptom onset.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Modified Rankin Scale (mRS) of 0-3
timeFrame: 90 (± 14 days) after procedure
Secondary outcomes:
measure: mRS of 0-2
timeFrame: 90 (± 14 days) after procedure
measure: mRS of 0-5
timeFrame: 90 (± 14 days) after procedure
measure: Symptomatic intracerebral hemorrhage (sICH)
timeFrame: 72 hours
measure: Early neurological deterioration
timeFrame: 72 hours
Other outcomes:
Locations:
city: Cần Thơ
country: Vietnam
facility: Can Tho Central General Hospital
city: Da Nang
country: Vietnam
facility: Da Nang Stroke Center
city: Ho Chi Minh City
country: Vietnam
facility: 115 PEOPLE's HOSPITAL
city: Ho Chi Minh City
country: Vietnam
facility: University Medical Center
Study officials:
References:
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citation: Sarraj A, Hassan AE, Abraham MG, Ortega-Gutierrez S, Kasner SE, Hussain MS, Chen M, Blackburn S, Sitton CW, Churilov L, Sundararajan S, Hu YC, Herial NA, Jabbour P, Gibson D, Wallace AN, Arenillas JF, Tsai JP, Budzik RF, Hicks WJ, Kozak O, Yan B, Cordato DJ, Manning NW, Parsons MW, Hanel RA, Aghaebrahim AN, Wu TY, Cardona-Portela P, Perez de la Ossa N, Schaafsma JD, Blasco J, Sangha N, Warach S, Gandhi CD, Kleinig TJ, Sahlein D, Elijovich L, Tekle W, Samaniego EA, Maali L, Abdulrazzak MA, Psychogios MN, Shuaib A, Pujara DK, Shaker F, Johns H, Sharma G, Yogendrakumar V, Ng FC, Rahbar MH, Cai C, Lavori P, Hamilton S, Nguyen T, Fifi JT, Davis S, Wechsler L, Pereira VM, Lansberg MG, Hill MD, Grotta JC, Ribo M, Campbell BC, Albers GW; SELECT2 Investigators. Trial of Endovascular Thrombectomy for Large Ischemic Strokes. N Engl J Med. 2023 Apr 6;388(14):1259-1271. doi: 10.1056/NEJMoa2214403. Epub 2023 Feb 10.
citation: Huo X, Ma G, Tong X, Zhang X, Pan Y, Nguyen TN, Yuan G, Han H, Chen W, Wei M, Zhang J, Zhou Z, Yao X, Wang G, Song W, Cai X, Nan G, Li D, Wang AY, Ling W, Cai C, Wen C, Wang E, Zhang L, Jiang C, Liu Y, Liao G, Chen X, Li T, Liu S, Li J, Gao F, Ma N, Mo D, Song L, Sun X, Li X, Deng Y, Luo G, Lv M, He H, Liu A, Zhang J, Mu S, Liu L, Jing J, Nie X, Ding Z, Du W, Zhao X, Yang P, Liu L, Wang Y, Liebeskind DS, Pereira VM, Ren Z, Wang Y, Miao Z; ANGEL-ASPECT Investigators. Trial of Endovascular Therapy for Acute Ischemic Stroke with Large Infarct. N Engl J Med. 2023 Apr 6;388(14):1272-1283. doi: 10.1056/NEJMoa2213379. Epub 2023 Feb 10.