Acute Ischemic StrokePHASENCT06361017
The Prediction of Hemorrhage Transformation by Cerebral Autoregulation in AIS Patient After Endovascular Thrombectomy
An observational study of Acute Ischemic Stroke and Endovascular Thrombectomy, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This observational study was designed for observe the cerebral hemodynamics and dynamic cerebral autoregulation (dCA) after endovascular thrombectomy (EVT) in acute ischemic stroke (AIS) patients. And analysis the relationship between the dCA damage degree and hemorrhage transformation (HT) and clinical outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Endovascular Thrombectomy, Dynamic Cerebral Autoregulation
- What is being tested?
- endovascular thrombectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 1 Mar 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients 18 years of age and older with acute ischemic stroke who underwent endovascular thrombectomy.
Who may be able to join
- (i) age ≥18 years; (ii) complete recanalization of the affected MCA (thrombolysis in cerebral infarction grade 2b or 3); and (iii) sufficient temporal windows to obtain flow signals for the MCA.
Who cannot join
- (i) inability to perform dCA after EVT due to restlessness; (ii) re-occlusion of the culprit MCA after EVT; and (iii) other conditions such as low cerebral blood flow caused by severe heart disease.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Vascular Ultrasonography, Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
Official title: Research of the Prediction of Hemorrhage Transformation and Clinical Outcome by Cerebral Autoregulation After Endovascular Thrombectomy in Acute Ischemic Stroke Patients Caused by Middle Cerebral Artery or Internal Carotid Artery Occlusion.
This observational study was designed for observe the cerebral hemodynamics and dynamic cerebral autoregulation (dCA) after endovascular thrombectomy (EVT) in acute ischemic stroke (AIS) patients. And analysis the relationship between the dCA damage degree and hemorrhage transformation (HT) and clinical outcome.
Patients: patients with AIS caused by middle cerebral artery or internal carotid artery occlusion who accepted EVT.
Read more
dCA Examination: dCA examinations were performed at 24 hours, 48 hours, 72 hours, and 5 days after EVT.
The objectives of the study were as follows: The changes of cerebral hemodynamics and parameters of dCA in different time periods after EVT were analyzed. So as to determine the correlation between hemodynamics and dCA change and HT and clinical outcome after EVT and to explore the predictors of HT and adverse clinical outcomes.
Read the detailed description
Part of the data from March 2022 to March 2022 was obtained, but it was still need more data and need a one-year follow-up of the data. Therefore, this is a 4 years prospective cohort study.
The objectives of the study were as follows: This observational study was designed for observe the cerebral hemodynamics and dynamic cerebral autoregulation (dCA) after endovascular thrombectomy (EVT) in acute ischemic stroke (AIS) patients. And analysis the relationship between the dCA damage degree and hemorrhage transformation (HT) and clinical outcomes. To explore the predictors of HT and adverse clinical outcomes.
- To enroll 300 cases of patients with AIS caused by middle cerebral artery or internal carotid artery occlusion who accepted EVT.
- dCA examinations were performed at 24 hours, 48 hours, 72 hours, and 5 days after EVT.
- The computed tomography was performed to distinguish if the patients have HT within 7 days after EVT.
- Utilizing the modified Rankin Scale (mRS), the clinical prognosis was assessed 3 months and 1 year after stroke. The outcomes were dichotomized according to the mRS score: favorable outcome (mRS ≤ 2) and unfavorable outcome (mRS: 3-6). During the telephone call follow-up, the clinician was unaware of any pertinent clinical or dCA information while examining each mRS score.
- All tests are non-invasive.
- Being tested
- endovascular thrombectomy
- Keywords
- Acute Ischemic Stroke, ultrasound, endovascular thrombectomy, dynamic cerebral autoregulation, Hemodynamics
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endovascular thrombectomyProcedure or surgery
Also called mechanical thrombectomy
All individuals were anesthetized, with local or general anesthesia dependent on the cooperation level of the patient. During the procedure, it was mandatory to administer intravenous heparin to maintain the activated clotting time between 250 and 300 s, except for subjects who received intravenous alteplase. The procedures were performed through the femoral artery. The selection of stent retriever type and size, along with any required devices, such as guide wires and catheters, as well as the intervention strategy, was at the interventionists' discretion.
| Study group | Role | What they receive |
|---|---|---|
| favorable outcome group | The favorable outcome group was defined as the modified Rankin Scale (mRS) score ≤2 in the AIS patients at 3 months after endovascular thrombectomy. Receives: Procedure: endovascular thrombectomy | |
| unfavorable outcome group | The unfavorable outcome group was defined as the modified Rankin Scale (mRS) score with 3-6 in the AIS patients at 3 months after endovascular thrombectomy. Receives: Procedure: endovascular thrombectomy | |
| HT group | HT group was defined as the AIS patients have hemorrhage transformation in 7 days after endovascular thrombectomy. Receives: Procedure: endovascular thrombectomy | |
| non-HT group | Non-HT group was defined as the AIS patients do not have hemorrhage transformation in 7 days after endovascular thrombectomy. Receives: Procedure: endovascular thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of hemorrhage transformation
The AIS patients have hemorrhage transformation detected by head computed tomography scans within 7 days after EVT
Measured: 7 days
Patients without hemorrhage transformation
The AIS patients do not have hemorrhage transformation detected by head computed tomography scans within 7 days after EVT
Measured: 7 days
The occurrence of unfavorable outcome
The modified Rankin Scale (mRS) score was 3-6 of AIS patients with EVT after 3 months.
Measured: 3 months
The occurrence of favorable outcome
The modified Rankin Scale (mRS) score ≤2 of AIS patients with EVT after 3 months.
Measured: 3 months
Secondary outcomes (2)
The occurrence of long-term unfavorable outcome
The modified Rankin Scale (mRS) score was 3-6 of AIS patients with EVT after 1 year.
Measured: 1 year
The occurrence of long-term favorable outcome
The modified Rankin Scale (mRS) score ≤2 of AIS patients with EVT after 1 year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Mar 2022
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingqi Xing, M.D., Principal investigator, Department of Vascular Ultrasonography, Xuanwu Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361017
- Sponsor's protocol ID
- QNPY2022007
- Acronym
- PHASE
- Status last verified
- Apr 2024
- First submitted
- 26 Mar 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tian G, Ji Z, Huang K, Lin Z, Pan S, Wu Y. Dynamic cerebral autoregulation is an independent outcome predictor of acute ischemic stroke after endovascular therapy. BMC Neurol. 2020 May 15;20(1):189. doi: 10.1186/s12883-020-01737-w.
PubMed 32414382Nogueira RG, Jadhav AP, Haussen DC, Bonafe A, Budzik RF, Bhuva P, Yavagal DR, Ribo M, Cognard C, Hanel RA, Sila CA, Hassan AE, Millan M, Levy EI, Mitchell P, Chen M, English JD, Shah QA, Silver FL, Pereira VM, Mehta BP, Baxter BW, Abraham MG, Cardona P, Veznedaroglu E, Hellinger FR, Feng L, Kirmani JF, Lopes DK, Jankowitz BT, Frankel MR, Costalat V, Vora NA, Yoo AJ, Malik AM, Furlan AJ, Rubiera M, Aghaebrahim A, Olivot JM, Tekle WG, Shields R, Graves T, Lewis RJ, Smith WS, Liebeskind DS, Saver JL, Jovin TG; DAWN Trial Investigators. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N Engl J Med. 2018 Jan 4;378(1):11-21. doi: 10.1056/NEJMoa1706442. Epub 2017 Nov 11.
PubMed 29129157Zhao W, Liu R, Yu W, Wu L, Wu C, Li C, Li S, Chen J, Song H, Hua Y, Ma Q, Ji X. Elevated pulsatility index is associated with poor functional outcome in stroke patients treated with thrombectomy: A retrospective cohort study. CNS Neurosci Ther. 2022 Oct;28(10):1568-1575. doi: 10.1111/cns.13888. Epub 2022 Jun 16.
PubMed 35707901Qiao Y, Liu R, Cai L, Zhao M, Yuan B, Fan S, Wang S, Li J, Wu L, Xing Y, Ma Q, Zhao W. Cerebral small vessel disease impairs dynamic cerebral autoregulation and mediates outcomes after stroke thrombectomy. Ther Adv Neurol Disord. 2026 Jul 29;19:17562864261470197. doi: 10.1177/17562864261470197. eCollection 2026.
PubMed 42539831
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of the Prediction of Hemorrhage Transformation and Clinical Outcome by Cerebral Autoregulation After Endovascular Thrombectomy in Acute Ischemic Stroke Patients Caused by Middle Cerebral Artery or Internal Carotid Artery Occlusion.
- ClinicalTrials.gov ID
- NCT06361017
- Acronym / sponsor ID
- PHASE / QNPY2022007
- Keywords
- Acute Ischemic Stroke, ultrasound, endovascular thrombectomy, dynamic cerebral autoregulation, Hemodynamics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study was designed for observe the cerebral hemodynamics and dynamic cerebral autoregulation (dCA) after endovascular thrombectomy (EVT) in acute ischemic stroke (AIS) patients. And analysis the relationship between the dCA damage degree and hemorrhage transformation (HT) and clinical outcome.
Patients: patients with AIS caused by middle cerebral artery or internal carotid artery occlusion who accepted EVT.
dCA Examination: dCA examinations were performed at 24 hours, 48 hours, 72 hours, and 5 days after EVT.
The objectives of the study were as follows: The changes of cerebral hemodynamics and parameters of dCA in different time periods after EVT were analyzed. So as to determine the correlation between hemodynamics and dCA change and HT and clinical outcome after EVT and to explore the predictors of HT and adverse clinical outcomes.
Detailed description
Part of the data from March 2022 to March 2022 was obtained, but it was still need more data and need a one-year follow-up of the data. Therefore, this is a 4 years prospective cohort study.
The objectives of the study were as follows: This observational study was designed for observe the cerebral hemodynamics and dynamic cerebral autoregulation (dCA) after endovascular thrombectomy (EVT) in acute ischemic stroke (AIS) patients. And analysis the relationship between the dCA damage degree and hemorrhage transformation (HT) and clinical outcomes. To explore the predictors of HT and adverse clinical outcomes.
- To enroll 300 cases of patients with AIS caused by middle cerebral artery or internal carotid artery occlusion who accepted EVT.
- dCA examinations were performed at 24 hours, 48 hours, 72 hours, and 5 days after EVT.
- The computed tomography was performed to distinguish if the patients have HT within 7 days after EVT.
- Utilizing the modified Rankin Scale (mRS), the clinical prognosis was assessed 3 months and 1 year after stroke. The outcomes were dichotomized according to the mRS score: favorable outcome (mRS ≤ 2) and unfavorable outcome (mRS: 3-6). During the telephone call follow-up, the clinician was unaware of any pertinent clinical or dCA information while examining each mRS score.
- All tests are non-invasive.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| favorable outcome group | – | Procedure: endovascular thrombectomyThe favorable outcome group was defined as the modified Rankin Scale (mRS) score ≤2 in the AIS patients at 3 months after endovascular thrombectomy. |
| unfavorable outcome group | – | Procedure: endovascular thrombectomyThe unfavorable outcome group was defined as the modified Rankin Scale (mRS) score with 3-6 in the AIS patients at 3 months after endovascular thrombectomy. |
| HT group | – | Procedure: endovascular thrombectomyHT group was defined as the AIS patients have hemorrhage transformation in 7 days after endovascular thrombectomy. |
| non-HT group | – | Procedure: endovascular thrombectomyNon-HT group was defined as the AIS patients do not have hemorrhage transformation in 7 days after endovascular thrombectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients 18 years of age and older with acute ischemic stroke who underwent endovascular thrombectomy.
Key inclusion criteria (1 listed)
- (i) age ≥18 years; (ii) complete recanalization of the affected MCA (thrombolysis in cerebral infarction grade 2b or 3); and (iii) sufficient temporal windows to obtain flow signals for the MCA.
Key exclusion criteria (1 listed)
- (i) inability to perform dCA after EVT due to restlessness; (ii) re-occlusion of the culprit MCA after EVT; and (iii) other conditions such as low cerebral blood flow caused by severe heart disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endovascular thrombectomyAlso: mechanical thrombectomyAll individuals were anesthetized, with local or general anesthesia dependent on the cooperation level of the patient. During the procedure, it was mandatory to administer intravenous heparin to maintain the activated clotting time between 250 and 300 s, except for subjects who received intravenous alteplase. The procedures were performed through the femoral artery. The selection of stent retriever type and size, along with any required devices, such as guide wires and catheters, as well as the intervention strategy, was at the interventionists' discretion. | Procedure or surgery | HT group, favorable outcome group, non-HT group, unfavorable outcome group |
Primary outcome
The occurrence of hemorrhage transformation
Time frame: 7 days
The AIS patients have hemorrhage transformation detected by head computed tomography scans within 7 days after EVT
Patients without hemorrhage transformation
Time frame: 7 days
The AIS patients do not have hemorrhage transformation detected by head computed tomography scans within 7 days after EVT
The occurrence of unfavorable outcome
Time frame: 3 months
The modified Rankin Scale (mRS) score was 3-6 of AIS patients with EVT after 3 months.
The occurrence of favorable outcome
Time frame: 3 months
The modified Rankin Scale (mRS) score ≤2 of AIS patients with EVT after 3 months.
2 secondary outcomes
The occurrence of long-term unfavorable outcome
Time frame: 1 year
The occurrence of long-term favorable outcome
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Background: PubMed 32414382Tian G, Ji Z, Huang K, Lin Z, Pan S, Wu Y. Dynamic cerebral autoregulation is an independent outcome predictor of acute ischemic stroke after endovascular therapy. BMC Neurol. 2020 May 15;20(1):189. doi: 10.1186/s12883-020-01737-w.
- Background: PubMed 29129157Nogueira RG, Jadhav AP, Haussen DC, Bonafe A, Budzik RF, Bhuva P, Yavagal DR, Ribo M, Cognard C, Hanel RA, Sila CA, Hassan AE, Millan M, Levy EI, Mitchell P, Chen M, English JD, Shah QA, Silver FL, Pereira VM, Mehta BP, Baxter BW, Abraham MG, Cardona P, Veznedaroglu E, Hellinger FR, Feng L, Kirmani JF, Lopes DK, Jankowitz BT, Frankel MR, Costalat V, Vora NA, Yoo AJ, Malik AM, Furlan AJ, Rubiera M, Aghaebrahim A, Olivot JM, Tekle WG, Shields R, Graves T, Lewis RJ, Smith WS, Liebeskind DS, Saver JL, Jovin TG; DAWN Trial Investigators. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N Engl J Med. 2018 Jan 4;378(1):11-21. doi: 10.1056/NEJMoa1706442. Epub 2017 Nov 11.
- Results publication: PubMed 35707901Zhao W, Liu R, Yu W, Wu L, Wu C, Li C, Li S, Chen J, Song H, Hua Y, Ma Q, Ji X. Elevated pulsatility index is associated with poor functional outcome in stroke patients treated with thrombectomy: A retrospective cohort study. CNS Neurosci Ther. 2022 Oct;28(10):1568-1575. doi: 10.1111/cns.13888. Epub 2022 Jun 16.
- Derived from this study: PubMed 42539831Qiao Y, Liu R, Cai L, Zhao M, Yuan B, Fan S, Wang S, Li J, Wu L, Xing Y, Ma Q, Zhao W. Cerebral small vessel disease impairs dynamic cerebral autoregulation and mediates outcomes after stroke thrombectomy. Ther Adv Neurol Disord. 2026 Jul 29;19:17562864261470197. doi: 10.1177/17562864261470197. eCollection 2026.
- Individual participant dataSharing planned: No
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yingqi Xing, M.D. principal investigator
Department of Vascular Ultrasonography, Xuanwu Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke and Endovascular Thrombectomy, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of hemorrhage transformation (time frame: 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06361017, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.