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

14 augusti 2026 uppdaterad av: 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, Interventional Study

This multicenter, prospective, and interventional 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.This study aims to evaluate a monitoring system based on cerebral autoregulation function and explore its predictive value for adverse neurological outcomes at the ultra-early stage following mechanical thrombectomy.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

227

Fas

  • Inte tillämpbar

Kontakter och platser

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Studiekontakt

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Studieorter

  • Kina
      • Beijing, Kina
        • Rekrytering
        • Beijing Shijitan Hospital, Capital Medical University
        • Huvudutredare:
          • Shen Li
        • Kontakt:
      • Dalian, Kina
        • Har inte rekryterat ännu
        • Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital)
        • Kontakt:
        • Huvudutredare:
          • Xiaoyan Lan
      • Heilongjiang, Kina
        • Har inte rekryterat ännu
        • The First Affiliated Hospital of Harbin Medical University
        • Huvudutredare:
          • Guang Zhang
        • Kontakt:
      • Shandong, Kina
        • Rekrytering
        • Weifang People's Hospital Affiliated to Weifang Medical University
        • Huvudutredare:
          • Weili Li
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  1. Age ≥ 18
  2. Diagnosis of acute ischemic stroke caused by anterior circulation large vessel occlusion (intracranial internal carotid artery or M1 segment of the middle cerebral artery).
  3. National Institutes of Health Stroke Scale (NIHSS) score ≥ 6 at presentation.
  4. Pre-stroke modified Rankin Scale (mRS) score ≤ 1.
  5. Symptom onset ≤ 24 hours.
  6. For patients with symptom onset within 6 hours: ASPECTS ≥ 6; for patients with symptom onset between 6 and 24 hours: age ≤ 80 years and ASPECTS ≥ 3.
  7. Underwent mechanical thrombectomy and achieved successful recanalization (mTICI 2b-3).
  8. Patient or legally authorized representative provides written informed consent.

Exclusion Criteria:

  1. Pre-procedural baseline imaging showing significant intracranial hemorrhagic transformation, intracranial arterial dissection, large chronic cerebral infarction, or intracranial metastasis from malignant tumors.
  2. Any degree of stenosis, plaque, dissection, severe tortuosity, or imaging evidence of unstable/vulnerable plaque in the target-side or bilateral common carotid artery or the origin of the internal carotid artery.
  3. Known history of carotid sinus hypersensitivity syndrome, severe autonomic dysfunction, sick sinus syndrome, high-grade atrioventricular conduction block, or other malignant arrhythmias.
  4. Refractory malignant hypertensive crisis (systolic blood pressure persistently ≥ 200 mmHg despite standardized intravenous antihypertensive therapy, or hemodynamic instability with shock).
  5. Known severe allergy to contrast agents or anesthetic drugs, or contraindications to antiplatelet/anticoagulation therapy.
  6. Severe systemic active infection, multiple organ failure, or expected survival < 6 months.
  7. Severe hepatic or renal dysfunction (ALT/AST > 3× upper limit of normal; estimated glomerular filtration rate < 30 mL/min) or severe coagulation disorders (platelet count < 40 × 10⁹/L, APTT > 50 s, INR > 3.0).
  8. Blood glucose < 2.7 mmol/L or > 22.2 mmol/L.
  9. Heart failure with NYHA class > II, or persistent systolic blood pressure < 100 mmHg.
  10. Central nervous system infection or intracranial tumor.
  11. Unstable vital signs.
  12. Severe alcohol dependence or drug dependence.
  13. Cognitive impairment or psychiatric disorders that may affect follow-up assessments.
  14. Pregnant or breastfeeding women.
  15. Participation in another clinical drug or device study within the past 30 days.
  16. Local skin damage or other conditions preventing proper placement of monitoring electrodes.
  17. Severe agitation or other conditions that interfere with data acquisition.
  18. Any other condition judged by investigators to potentially affect study results.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Cerebral Autoregulation Monitoring After Mechanical Thrombectomy
Participants with acute intracranial large vessel occlusion in the anterior circulation who achieve successful recanalization (mTICI 2b-3) after mechanical thrombectomy will undergo bedside cerebral autoregulation monitoring. Monitoring includes continuous near-infrared spectroscopy (NIRS) to record cerebral oxygen saturation and continuous noninvasive or invasive blood pressure measurement for 25-30 minutes immediately after recanalization. A carotid compression test is performed to dynamically assess cerebral autoregulation.
Enhet: NIRS-based cerebral oxygenation and blood pressure monitoring
Bedside multimodal cerebral autoregulation monitoring performed immediately after successful mechanical thrombectomy (mTICI 2b-3). Monitoring includes continuous near-infrared spectroscopy (NIRS) to record cerebral oxygen saturation and continuous noninvasive or invasive arterial blood pressure measurement for 25-30 minutes. Cerebral oxygenation index (COx) is calculated as a moving Pearson correlation coefficient between mean arterial pressure and cerebral oxygen saturation over 30 consecutive 10-second epochs (300 seconds). COx ≥ 0.3 indicates impaired cerebral autoregulation, while COx < 0.3 indicates preserved autoregulation. Changes in cerebral oxygen saturation before and after carotid compression are also used to assess autoregulatory.
Procedur: Carotid compression test
A carotid compression test is performed by compressing the common carotid artery at the lower one-third of the neck (avoiding the carotid sinus) against the transverse process of C6 until pulsation disappears for 5-10 seconds, followed by release. If the brain oxygen saturation has increased compared to before the test, it indicates that the brain's automatic blood flow regulation function is intact; conversely, if it has decreased, it is regarded as a damaged automatic blood flow regulation function of the brain.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Distribution of Modified Rankin scale
Tidsram: 90±7days
the distribution of Modified Rankin scale (mRS) [ranging from 0 (normal) to 6 (death)]
90±7days

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Early neurological improvement
Tidsram: 24±12 hours
Early neurological improvement is defined as a reduction of ≥8 on the National Institutes of Health Stroke Scale [ranging from 0 to 42 points, with higher numbers indicating greater severity] or National nstitutes of Health Stroke Scale zero to one 24 hours after thrombectomy.
24±12 hours

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Beijing Shijitan Hospital, Capital Medical University

Utredare

  • Huvudutredare: Shen Li, Beijing Shijitan Hospital, Capital Medical University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

31 juli 2026

Primärt slutförande (Beräknad)

31 januari 2027

Avslutad studie (Beräknad)

5 februari 2027

Studieregistreringsdatum

Först inskickad

31 juli 2026

Först inskickad som uppfyllde QC-kriterierna

31 juli 2026

Första postat (Faktisk)

5 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • FACTOR

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

The deidentified individual participant data underlying this article will not be publicly available. However, the data may be made available to researchers upon reasonable request to the corresponding author, subject to approval by the institutional review board and execution of a data access agreement.

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