Early Identification of Malignant Brain Edema in laRge Artery oCclusive Stroke After Endovascular Therapy (EMBRACE Study)

NCT06451887 | Recruiting DMC

• 1 other identifier: KY2024058
• Study Type: observational
• Target: 1,950
• Locations: 1 country
• Sites: 1

Brief Summary

To design and validate a predictive model for malignant brain edema after endovascular thrombectomy.

Conditions

Endovascular Therapy; Brain Edema; Prediction Model; Ischemic Stroke

Keywords

Endovascular therapy; Brain edema; Prediction model; Ischemic stroke

Outcome Measures

Primary Outcomes (1)

• The occurrence of MBE

  Patients developed MBE within 3 days post-EVT

  3 days post-EVT

Secondary Outcomes (2)

• 90 days mRS score

  90 days after EVT

• PH

  3-5 days after EVT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study is a multicenter, prospective, observational clinical registry study, commenced on April 1, 2024, and is expected to end in June 2027. Participants were ALVOS patients undergoing EVT treatment in neurology departments from multiple stroke centers. The data from Zhejiang Provincial People's Hospital compose the model training cohort, while data from other centers serve as an independent external validation cohort. The protocol of the study has been approved by the human Ethics Committee of Zhejiang Provincial People's Hospital (KY2024058). All clinical investigations will be conducted according to the principles set in the Declaration of the Helsinki.

You may qualify if:

• (1)Age \> 18 years old; (2)Onset of stroke to hospital admission \< 24 hours; (3)Admission with a head CT scan ruling out hemorrhage; (4)Patients undergoing CT perfusion scan before treatment; (5)Confirmation of internal carotid artery (ICA) or middle cerebral artery (MCA) occlusion or tandem occlusion by Digital Subtraction Angiography (DSA) and subsequent EVT; (6)complete 3-months follow-up.

You may not qualify if:

• (1)Poor quality of preoperative CT perfusion imaging; (2)Posterior circulation occlusion or isolated anterior cerebral artery occlusion; (3)Presence of other severe diseases such as malignant tumors, severe organ failure, or other life-threatening conditions with an expected survival period of less than 90 days; (4)Incomplete imaging and clinical data.

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

Study Sites (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

RECRUITING

MeSH Terms

Conditions

Brain Edema; Ischemic Stroke

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Sheng Zhang

CONTACT

18758188313; zhangsheng@hmc.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 11, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

CN (1)