Investigating head position after endovascular therapy for stroke
Head Positioning After Endovascular Therapy for Acute Ischemic Stroke: A Randomized Controlled Trial
This study tests if keeping the head elevated after stroke treatment helps patients recover better than lying flat.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1332 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Affiliated Hospital Of Southwest Medical University Academic / other |
| Locations | 67 sites (Chongqing, Chongqing and 66 other locations) |
| Trial ID | NCT06115707 on ClinicalTrials.gov |
What this trial studies
This trial aims to determine whether elevating the head position after endovascular treatment can enhance the functional outcomes of patients with acute large vessel occlusion in the anterior circulation. Participants will be randomly assigned to either a lying flat position or an elevated head position for 72 hours following their treatment. The study will focus on patients with significant stroke symptoms and confirmed vessel occlusion, assessing their recovery over a 90-day period. The goal is to clarify the optimal head positioning to improve patient outcomes post-treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with acute ischemic stroke and confirmed anterior circulation large vessel occlusion.
Not a fit: Patients with mild strokes or those with multiple vascular territory occlusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery outcomes for stroke patients following endovascular therapy.
How similar studies have performed: Previous studies have shown mixed results regarding head positioning in stroke patients, making this approach both relevant and necessary for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Clinical signs consistent with acute ischemic stroke; 2. Age ≥ 18 years old; 3. Proved anterior circulation large vessel occlusion on digital subtraction angiography (ICA, M1, M2) with/without cervical lesion (tandem); 4. NIHSS score ≥ 8 points before endovascular treatment; 5. ASPECTS score ≤ 7 points before endovascular treatment; 6. Successful vessel recanalization after endovascular treatment (defined as an eTICI score of 2b, 2c, or 3) ; 7. The time from onset to randomization ≤ 24 hours (the onset time is defined as the last normal time); 8. Written informed consent is obtained from patients and/or their legal representatives. Exclusion Criteria: 1. Pre-stroke mRS score\>1 point; 2. Patients with acute occlusions in multiple vascular territories (e.g. bilateral anterior circulation, or anterior/posterior circulation); 3. Currently in pregnant or lactating or serum beta HCG test is positive on admission; 4. Contraindications to a flat head position; 5. Any terminal illness with life expectancy less than 6 months; 6. Participating in other clinical trials; 7. Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations; 8. Unlikely to be available for 90-day follow-up.
Where this trial is running
Chongqing, Chongqing and 66 other locations
- Chongqing Banan District People's Hospital — Chongqing, Chongqing, China (Recruiting)
- Chongqing Bishan District People's Hospital — Chongqing, Chongqing, China (Recruiting)
- Chongqing Ninth People's Hospital — Chongqing, Chongqing, China (Recruiting)
- Yongchuan Hospital Affiliated to Chongqing Medical University — Chongqing, Chongqing, China (Recruiting)
- The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
- Longyan First Hospital — Longyan, Fujian, China (Recruiting)
- Dingxi People's Hospital — Dingxi, Gansu, China (Recruiting)
- Jiuquan People's Hospital — Jiuquan, Gansu, China (Recruiting)
- Gansu Provincial Hospital of Traditional Chinese Medicine — Lanzhou, Gansu, China (Recruiting)
- Lanzhou University First Hospital — Lanzhou, Gansu, China (Recruiting)
- Lanzhou University Second Hospital — Lanzhou, Gansu, China (Recruiting)
- Tianshui First People's Hospital — Tianshui, Gansu, China (Recruiting)
- Zhujiang Hospital of Southern Medical University — Guanzhou, Guangdong, China (Recruiting)
- Guangdong Provincial People's Hospital Heyuan Hospital — Heyuan, Guangdong, China (Recruiting)
- Baise People's Hospital — Baise, Guangxi, China (Recruiting)
- Nanning Third People's Hospital — Nanning, Guangxi, China (Recruiting)
- Qiannan Prefecture People's Hospital — Dujun, Guizhou, China (Recruiting)
- Xingyi People's Hospital — Xingyi, Guizhou, China (Recruiting)
- The First Affiliated Hospital of Hainan Medical College — Haikou, Hainan, China (Recruiting)
- Jiamusi Central Hospital — Jiamusi, Heilongjiang, China (Recruiting)
- Yichun First Hospital — Yichun, Heilongjiang, China (Recruiting)
- Anyang People's Hospital — Anyang, Henan, China (Recruiting)
- Xihua County People's Hospital — Zhoukou, Henan, China (Recruiting)
- Shiyan taihe hospital — Shiyan, Hubei, China (Recruiting)
- Ningxiang First People's Hospital — Changsha, Hunan, China (Recruiting)
- The First People's Hospital of Chenzhou City — Chenzhou, Hunan, China (Recruiting)
- Ganzhou Municipal Hospital — GanZhou, Jiangxi, China (Recruiting)
- Ganzhou People's Hospital — Ganzhou, Jiangxi, China (Recruiting)
- Xingguo County People's Hospital — Ganzhou, Jiangxi, China (Recruiting)
- Jiangxi Provincial People's Hospital — Nanchang, Jiangxi, China (Recruiting)
- The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
- Dalian 967 Hospital — Dalian, Liaoning, China (Recruiting)
- Ningxia Hui Autonomous Region People's Hospital — Yinchuan, Ningxia, China (Recruiting)
- The Fifth People's Hospital of Qinghai Province — Xining, Qinghai, China (Recruiting)
- Baoji High tech Hospital — Baoji, Shaanxi, China (Recruiting)
- Northwest University Affiliated Hospital — Xi'an, Shaanxi, China (Recruiting)
- Xianyang First People's Hospital — Xianyang, Shaanxi, China (Recruiting)
- Yulin First Hospital — Yulin, Shaanxi, China (Recruiting)
- Rizhao Traditional Chinese Medicine Hospital — Rizhao, Shandong, China (Recruiting)
- Shanxi Provincial Hospital — Taiyuan, Shanxi, China (Recruiting)
- Xidian Group Hospital — Xi'an, Shanxi, China (Recruiting)
- Chengdu Sixth People's Hospital — Chengdu, Sichuan, China (Recruiting)
- Chongzhou People's Hospital — Chengdu, Sichuan, China (Recruiting)
- Deyang People's Hospital — Deyang, Sichuan, China (Recruiting)
- Guangyuan First People's Hospital — Guangyuan, Sichuan, China (Recruiting)
- Affiliated Hospital of Southwest Medical University — Luzhou, Sichuan, China (Recruiting)
- Gulin County People's Hospital — Luzhou, Sichuan, China (Recruiting)
- Beichuan County People's Hospital — Mianyang, Sichuan, China (Recruiting)
- Mianyang 404 Hospital — Mianyang, Sichuan, China (Recruiting)
- Mianyang Central Hospital — Mianyang, Sichuan, China (Recruiting)
+17 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Zhengzhou Yuan
- Email: coneuro@163.com
- Phone: 868303165661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.