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

Acute Ischemic Stroke Clinical Trial

Official title:

Predictors of Good Outcomes in Thrombectomy for Stroke Patients Within 24 Hours From Symptom Onset With Large Infarct Core

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06016348
• Other study ID #: 115
• Status: Recruiting
• Start date: July 28, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: December 2023
• Source: 115 People's Hospital
• Contact: Quoc-Trung Nguyen, M.D
• Phone: +84938477516
• Email: quoctrungyds09[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Intervention

Procedure:
• Endovascular treatment
This procedure is instrumental in restoring cerebral blood flow by addressing the clot-induced obstruction within brain-supplying blood vessels.

Locations

Country	Name	City	State
Vietnam	Can Tho Central General Hospital	C?n Tho
Vietnam	Da Nang Stroke Center	Da Nang
Vietnam	115 PEOPLE's HOSPITAL	Ho Chi Minh City
Vietnam	University Medical Center	Ho Chi Minh City

Sponsors (2)

Lead Sponsor	Collaborator
115 People's Hospital	University of Medicine and Pharmacy at Ho Chi Minh City

Country where clinical trial is conducted

Vietnam, 

References & Publications (3)

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, — View 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. — View Citation

Yoshimura S, Sakai N, Yamagami H, Uchida K, Beppu M, Toyoda K, Matsumaru Y, Matsumoto Y, Kimura K, Takeuchi M, Yazawa Y, Kimura N, Shigeta K, Imamura H, Suzuki I, Enomoto Y, Tokunaga S, Morita K, Sakakibara F, Kinjo N, Saito T, Ishikura R, Inoue M, Morimoto T. Endovascular Therapy for Acute Stroke with a Large Ischemic Region. N Engl J Med. 2022 Apr 7;386(14):1303-1313. doi: 10.1056/NEJMoa2118191. Epub 2022 Feb 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Modified Rankin Scale (mRS) of 0-3	The rate of independent ambulation (mRS 0-3). The scale runs from 0-6, running from perfect health without symptoms to death.	90 (± 14 days) after procedure
Secondary	mRS of 0-2	The rate of functional independence (mRS 0-2)	90 (± 14 days) after procedure
Secondary	mRS of 0-5	The survival rate	90 (± 14 days) after procedure
Secondary	Symptomatic intracerebral hemorrhage (sICH)	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.	72 hours
Secondary	Early neurological deterioration	Clinical worsening that was higher by =4 points than the value at baseline during the first 72 h after ischaemic stroke.	72 hours