Ultra-early Identification of Futile Recanalization After Reperfusion Therapy in Acute Ischemic Stroke Based on Cerebral Autoregulation (CAREFUL-CA)

April 30, 2026 updated by: Shen Li, Beijing Shijitan Hospital, Capital Medical University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
129

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Beijing Shijitan Hospital, Capital Medical University
        • Principal Investigator:
          • Shen Li
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • The First Affiliated Hospital of Harbin Medical University
        • Contact:
        • Principal Investigator:
          • Guang Zhang
    • Liaoning
      • Dalian, Liaoning, China
        • Not yet recruiting
        • Dalian Municipal Central Hospital
        • Contact:
        • Principal Investigator:
          • Tieping Fan
    • Shandong
      • Weifang, Shandong, China
        • Recruiting
        • Weifang People's Hospital Affiliated to Weifang Medical University
        • Contact:
        • Principal Investigator:
          • Weili Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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).

Description

Inclusion Criteria:

  1. Age ≥ 18
  2. 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.
  3. NIHSS score ≥ 6 obtained prior to endovascular treatment.
  4. Modified Rankin Scale ≤ 1 prior to qualifying stroke.
  5. 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
  6. 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.
  7. Patient/Legally Authorized Representative has signed the Informed Consent Form.

Exclusion Criteria:

  1. Baseline CT/MRI confirms the presence of multiple vascular territory acute strokes.
  2. Baseline CT/MRI confirms the presence of arterial dissection.
  3. Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy.
  4. Known allergies or intolerances to antiplatelet agents, anticoagulation drugs, iodinated contrast and/or anesthetics.
  5. Severe infection (e.g. sepsis) or multiple organ failure.
  6. 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.
  7. Baseline platelet count < 50 × 10^9/L.
  8. Blood glucose concentration<50 mg/dL (2.7 mmol/L) or >400 mg/dL (22.2 mmol/L).
  9. Refractory hypertension that is difficult to control by medication (Defined as persistent systolic blood pressure>185 mmHg or diastolic blood pressure>110 mmHg).
  10. Severe cardiomyopathy with heart failure (LVEF ≤ 30% or NYHA class IV), acute myocardial infarction, or unstable angina.
  11. Untreated moderate or severe coronary artery stenosis, or previous coronary artery bypass surgery.
  12. 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).
  13. Known intracranial aneurysm, and cerebral arteriovenous malformation.
  14. Malignant brain tumor or CNS infection.
  15. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations (e.g., dementia or mental illness)
  16. Female who is pregnant or lactating at time of admission.
  17. Anticipated life expectancy < 6 months.
  18. Current participation in another investigational drug or device study.
  19. local skin damage or other conditions that cannot cooperate with electrode sticking.
  20. severe agitation or other conditions affecting data collection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Diagnostic test: diagnostic accuracy study
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Month 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The sensitivity, specificity and area under the receiver operating characteristic curve for early neurological improvement
Time Frame: Day 1
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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Shijitan Hospital, Capital Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shen Li, Beijing Shijitan Hospital, Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAREFUL-CA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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