Acute Ischemic StrokeCAREFUL-CANCT07556068
Ultra-early Identification of Futile Recanalization After Reperfusion Therapy in Acute Ischemic Stroke Based on Cerebral Autoregulation
An observational study of Acute Ischemic Stroke and Cerebral Autoregulation, run by Beijing Shijitan Hospital, Capital Medical University at 4 sites in China.
Trial summary
This multicenter, prospective, observational diagnostic accuracy study enrolls patients undergoing thrombectomy with intraoperative cerebral autoregulation monitoring and follows them up at predefined time points up to 90 days post-enrollment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Cerebral Autoregulation
- What is being tested?
- diagnostic accuracy study
- How many people
- 129 participants
- Where
- 4 sitesChina
- Study dates
- 20 Apr 2026to 20 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with acute ischemic stroke due to anterior circulation large-vessel occlusion who undergo mechanical thrombectomy within 24 hours of the last known normal time, achieving successful recanalization (mTICI ≥ 2b).
Who may be able to join
- Age ≥ 18
- Clinical signs consistent with acute ischemic stroke with large vessel occlusion in the anterior circulation (intracranial segment of the internal carotid artery, middle cerebral artery M1 segment) demonstrated with CTA/MRA/DSA.
- NIHSS score ≥ 6 obtained prior to endovascular treatment.
- Modified Rankin Scale ≤ 1 prior to qualifying stroke.
- Acute ischemic stroke, undergone endovascular treatment within 24 hours of onset (time of stroke is the last known normal for wake-up stroke or with unknown onset time).with reaching the goal of mTICI grade 2b-3
- For patients with symptom onset within 6 hours: ASPECTS ≥ 3; for patients with symptom onset between 6 and 24 hours: age ≤ 80 years and ASPECTS ≥ 3.
- Patient/Legally Authorized Representative has signed the Informed Consent Form.
Who cannot join
- Baseline CT/MRI confirms the presence of multiple vascular territory acute strokes.
- Baseline CT/MRI confirms the presence of arterial dissection.
- Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy.
- Known allergies or intolerances to antiplatelet agents, anticoagulation drugs, iodinated contrast and/or anesthetics.
- Severe infection (e.g. sepsis) or multiple organ failure.
- Known hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency; oral anticoagulant therapy with INR > 3; or use of a factor Xa inhibitor within the preceding 48 hours with an abnormal aPTT.
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- Baseline platelet count < 50 × 10^9/L.
- Blood glucose concentration<50 mg/dL (2.7 mmol/L) or >400 mg/dL (22.2 mmol/L).
- Refractory hypertension that is difficult to control by medication (Defined as persistent systolic blood pressure>185 mmHg or diastolic blood pressure>110 mmHg).
- Severe cardiomyopathy with heart failure (LVEF ≤ 30% or NYHA class IV), acute myocardial infarction, or unstable angina.
- Untreated moderate or severe coronary artery stenosis, or previous coronary artery bypass surgery.
- Current hemodialysis or peritoneal dialysis; known severe renal insufficiency with estimated glomerular filtration rate < 30 mL/min or serum creatinine > 220 μmol/L (2.5 mg/dL).
- Known intracranial aneurysm, and cerebral arteriovenous malformation.
- Malignant brain tumor or CNS infection.
- Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations (e.g., dementia or mental illness)
- Female who is pregnant or lactating at time of admission.
- Anticipated life expectancy < 6 months.
- Current participation in another investigational drug or device study.
- local skin damage or other conditions that cannot cooperate with electrode sticking.
- severe agitation or other conditions affecting data collection.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality
Shen Li, 010-63925616, lishen@mail.ccmu.edu.cn
Shen Li
- Not yet recruiting
Dalian Municipal Central Hospital
Dalian, Liaoning
Tieping Fan, 13841132091@126.com
Tieping Fan
- Recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Guang Zhang, Zhangguang@hrbmu.edu.cn
Guang Zhang
- Recruiting
Weifang People's Hospital Affiliated to Weifang Medical University
Weifang, Shandong
Weili Li, liweili0536@163.com
Weili Li
About this study
Official title: Ultra-early Identification of Futile Recanalization After Reperfusion Therapy in Acute Ischemic Stroke Based on Cerebral Autoregulation Monitoring: a Multicenter, Prospective, Observational Study
This multicenter, prospective, observational diagnostic accuracy study enrolls patients undergoing thrombectomy with intraoperative cerebral autoregulation monitoring and follows them up at predefined time points up to 90 days post-enrollment. The study aims to determine whether impaired cerebral autoregulation during thrombectomy can serve as an ultra-early biomarker for predicting futile recanalization in patients with acute ischemic stroke.
Read the detailed description
Acute ischemic stroke (AIS) is the leading cause of death and disability in China. Landmark randomized controlled trials have demonstrated the benefit of endovascular therapy for patientswith acute stroke due to large-vessel occlusion. Despite successful recanalization rates exceeding 80%, more than half of patients fail to achieve functional independence following thrombectomy a phenomenon termed futile recanalization. Ultra-early identification of futile recanalization is critical for guiding individualized treatment strategies. Timely recognition of at-risk patients may enable targeted interventions - such as intra-arterial thrombolysis, rescue therapy, and neuroprotective measures that could potentially reverse unfavorable outcomes or mitigate adverse events. Monitoring cerebral autoregulation (CA) function during thrombectomy represents a promising approach for the ultra-early prediction of futile recanalization. This multicenter, prospective, observational diagnostic accuracy study aims to validate the hypothesis that intraoperative CA monitoring during thrombectomy can predict futile recanalization. A total of 129 participants will be enrolled and divided into a modeling cohort and a validation cohort. Participants will undergo face-to-face assessments at 24 ± 12 hours, 48 ± 12 hours, and 7 ± 3 days post-enrollment (or at discharge). A follow-up assessment will be conducted via telephone or in-person interview at 90 ± 7 days post-enrollment. The primary endpoints include the sensitivity, specificity, and area under the receiver operating characteristic curve of impaired CA for predicting futile recanalization.
- Conditions
- Acute Ischemic Stroke, Cerebral Autoregulation
- Being tested
- diagnostic accuracy study
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic accuracy studyDiagnostic test
Cerebral autoregulation is assessed intraoperatively during thrombectomy using near-infrared spectroscopy (NIRS)-derived cerebral oxygen saturation combined with continuous noninvasive or invasive arterial blood pressure monitoring. The correlation between cerebral oxygen saturation and arterial blood pressure is analyzed to quantify cerebral autoregulation status. This monitoring is performed as part of routine clinical care and does not constitute an additional research intervention.
| Study group | Role | What they receive |
|---|---|---|
| Cerebral autoregulation monitoring cohort | The consecutively enrolled participants undergoing thrombectomy for acute ischemic stroke. Intraoperative cerebral autoregulation will be assessed using near-infrared spectroscopy (NIRS)-based cerebral oxygen saturation monitoring combined with continuous blood pressure monitoring (noninvasive or invasive). This cohort will be used to develop the predictive and validate model for futile recanalization. Receives: Diagnostic Test: diagnostic accuracy study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity, specificity and area under the receiver operating characteristic curve for percentage of Modified Rankin scale 0-2
"Futile recanalization" is defined as a poor neurological prognosis (90-day Modified Rankin scale > 2) in patients with acute large vessel occlusion ischemic stroke who have achieved good recanalization grade (mTICI≥2b) after endovascular treatment. The sensitivity, specificity and area under the receiver operating characteristic curve of cerebral autoregulation coefficient in predicting the percentage of mRS scale 0-2 (Modified Rankin scale [ranging from 0 (normal) to 6 (death) were calculated.
Measured: Month 3
Secondary outcomes (1)
The sensitivity, specificity and area under the receiver operating characteristic curve for early neurological improvement
The sensitivity, specificity and area under the receiver operating characteristic curve of cerebral autoregulation coefficient in predicting early neurological improvement were calculated. "Early neurological improvement" is defined as an improvement of 8 or more points in NIHSS score or a decrease to 0-1 within 24 hours after recanalization.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start20 Apr 2026
- Primary completion15 Oct 2026 (estimated)
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- 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
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Shijitan Hospital, Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Li, Beijing Shijitan Hospital, Capital Medical University
- Investigators
- Shen Li, Principal investigator, Beijing Shijitan Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556068
- Sponsor's protocol ID
- CAREFUL-CA
- Acronym
- CAREFUL-CA
- Status last verified
- Apr 2026
- First submitted
- 18 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-early Identification of Futile Recanalization After Reperfusion Therapy in Acute Ischemic Stroke Based on Cerebral Autoregulation Monitoring: a Multicenter, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT07556068
- Acronym / sponsor ID
- CAREFUL-CA / CAREFUL-CA
- Conditions
- Acute Ischemic Stroke, Cerebral Autoregulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Beijing Shijitan Hospital, Capital Medical UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 29 Apr 2026 (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 multicenter, prospective, observational diagnostic accuracy study enrolls patients undergoing thrombectomy with intraoperative cerebral autoregulation monitoring and follows them up at predefined time points up to 90 days post-enrollment. The study aims to determine whether impaired cerebral autoregulation during thrombectomy can serve as an ultra-early biomarker for predicting futile recanalization in patients with acute ischemic stroke.
Detailed description
Acute ischemic stroke (AIS) is the leading cause of death and disability in China. Landmark randomized controlled trials have demonstrated the benefit of endovascular therapy for patientswith acute stroke due to large-vessel occlusion. Despite successful recanalization rates exceeding 80%, more than half of patients fail to achieve functional independence following thrombectomy a phenomenon termed futile recanalization. Ultra-early identification of futile recanalization is critical for guiding individualized treatment strategies. Timely recognition of at-risk patients may enable targeted interventions - such as intra-arterial thrombolysis, rescue therapy, and neuroprotective measures that could potentially reverse unfavorable outcomes or mitigate adverse events. Monitoring cerebral autoregulation (CA) function during thrombectomy represents a promising approach for the ultra-early prediction of futile recanalization. This multicenter, prospective, observational diagnostic accuracy study aims to validate the hypothesis that intraoperative CA monitoring during thrombectomy can predict futile recanalization. A total of 129 participants will be enrolled and divided into a modeling cohort and a validation cohort. Participants will undergo face-to-face assessments at 24 ± 12 hours, 48 ± 12 hours, and 7 ± 3 days post-enrollment (or at discharge). A follow-up assessment will be conducted via telephone or in-person interview at 90 ± 7 days post-enrollment. The primary endpoints include the sensitivity, specificity, and area under the receiver operating characteristic curve of impaired CA for predicting futile recanalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebral autoregulation monitoring cohort | – | Diagnostic Test: diagnostic accuracy studyThe consecutively enrolled participants undergoing thrombectomy for acute ischemic stroke. Intraoperative cerebral autoregulation will be assessed using near-infrared spectroscopy (NIRS)-based cerebral oxygen saturation monitoring combined with continuous blood pressure monitoring (noninvasive or invasive). This cohort will be used to develop the predictive and validate model for futile recanalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke due to anterior circulation large-vessel occlusion who undergo mechanical thrombectomy within 24 hours of the last known normal time, achieving successful recanalization (mTICI ≥ 2b).
Key inclusion criteria (7 listed)
- Age ≥ 18
- Clinical signs consistent with acute ischemic stroke with large vessel occlusion in the anterior circulation (intracranial segment of the internal carotid artery, middle cerebral artery M1 segment) demonstrated with CTA/MRA/DSA.
- NIHSS score ≥ 6 obtained prior to endovascular treatment.
- Modified Rankin Scale ≤ 1 prior to qualifying stroke.
- Acute ischemic stroke, undergone endovascular treatment within 24 hours of onset (time of stroke is the last known normal for wake-up stroke or with unknown onset time).with reaching the goal of mTICI grade 2b-3
Key exclusion criteria (20 listed)
- Baseline CT/MRI confirms the presence of multiple vascular territory acute strokes.
- Baseline CT/MRI confirms the presence of arterial dissection.
- Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy.
- Known allergies or intolerances to antiplatelet agents, anticoagulation drugs, iodinated contrast and/or anesthetics.
- Severe infection (e.g. sepsis) or multiple organ failure.
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 |
|---|---|---|
| diagnostic accuracy studyCerebral autoregulation is assessed intraoperatively during thrombectomy using near-infrared spectroscopy (NIRS)-derived cerebral oxygen saturation combined with continuous noninvasive or invasive arterial blood pressure monitoring. The correlation between cerebral oxygen saturation and arterial blood pressure is analyzed to quantify cerebral autoregulation status. This monitoring is performed as part of routine clinical care and does not constitute an additional research intervention. | Diagnostic test | Cerebral autoregulation monitoring cohort |
Primary outcome
The sensitivity, specificity and area under the receiver operating characteristic curve for percentage of Modified Rankin scale 0-2
Time frame: Month 3
"Futile recanalization" is defined as a poor neurological prognosis (90-day Modified Rankin scale > 2) in patients with acute large vessel occlusion ischemic stroke who have achieved good recanalization grade (mTICI≥2b) after endovascular treatment. The sensitivity, specificity and area under the receiver operating characteristic curve of cerebral autoregulation coefficient in predicting the percentage of mRS scale 0-2 (Modified Rankin scale [ranging from 0 (normal) to 6 (death) were calculated.
1 secondary outcome
The sensitivity, specificity and area under the receiver operating characteristic curve for early neurological improvement
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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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.
Shen Li principal investigator
Beijing Shijitan Hospital, Capital Medical University
4 sites 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 Cerebral Autoregulation, run by Beijing Shijitan Hospital, Capital Medical University at 4 sites 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 7 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zidong Li (010-63925615, walx592815088@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity, specificity and area under the receiver operating characteristic curve for percentage of Modified Rankin scale 0-2 (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2026.