Intra-arterial Selective Hypothermic Magnesium Sulfate Infusion in Combination With Endovascular Thrombectomy in Acute Ischemic Stroke
A legfontosabb adatok
- Ki végzi
- Capital Medical University
- Hol
- Xuzhou (Kína)A helyszín megnézése
- Azonosító
- Állapot
- Toboroz
- Fázis
- 1/2. fázis
- Résztvevők
- 42 fő, tervezett
- Kezdés
- 2025. szept. 15.
- Várható befejezés
- 2027. márc. 30.
- A vizsgálat típusa
- Beavatkozással járó, 5 csoportAz egyik csoport színlelt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (350 ml).
- Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (500 ml).
- Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (650 ml).
- Endovascular thrombectomy
- Phase 2 Fixed-Volume Concentration-Escalation Cohort
- A regiszteradat frissítve
- 2026. november 12.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat 18 és 80 év közötti felnőtteket keres, akiknek hirtelen agyi érelzáródás okozta szélütése van az agy elülső részén, és vérrög-eltávolító beavatkozást kapnak.
- Életkor
- 18-80 év
- Nem
- Mindkét nem részt vehet.
- A betegség stádiuma
- Az agy elülső részén kialakult akut ischaemiás stroke, amelyben a belső nyaki verőér vagy a középső agyi verőér M1 vagy M2 szakasza el van zárva. NIHSS pontszám legalább 6. A vérrög eltávolítása a tünetek kezdetétől számított 24 órán belül, és a képalkotó vizsgálatok eredménye megfelel a vizsgálat időablakra vonatkozó szabályainak.
- Korábbi kezelés
- Érbe vezetett katéteres vérrög-eltávolításon (endovascularis thrombectomia) kell átesnie. A stroke előtt teljesen önálló volt (mRS pontszám 0-1).
A részvétel fő kizáró okai
- Vérzés az agyban vagy az agy körül
- Terhesség vagy szoptatás
- Súlyos máj- vagy vesebetegség
- Jódtartalmú kontrasztanyag-allergia
- Jelenleg másik beavatkozásos vizsgálatban vesz részt, vagy vizsgálati gyógyszert vagy eszközt használ
A regiszter feltételei, szó szerint
Mind a 32 feltétel megnézéseKevesebb
Ki vehet részt
- Age range of 18-80 years old (including critical value)
- No gender restrictions
- The clinical diagnosis is acute ischemic stroke of the anterior circulation, and the site of acute occlusion of the responsible vessel is located in the intracranial segment of the internal carotid artery and the M1 or M2 segment of the middle cerebral artery
- The symptoms and signs are consistent with acute anterior circulation ischemic stroke, NIHSS≥6
- The time from onset to endovascular thrombectomy of acute ischemic stroke is within 24 hours
- Indications for endovascular thrombectomy of acute ischemic stroke: ① ASPECTS score ≥ 6 points, within 6 hours of onset; ② 6-16 hours after onset, meeting DEFUSE-3 criteria (infarct core volume < 70 mL, mismatch rate ≥ 1.8 and mismatch volume > 15 mL) or DAWN criteria (NIHSS ≥ 10 and infarct core volume < 31 mL); Or NIHSS ≥ 20 and infarct volume 31-51 mL); ③ Within 16-24 hours of onset, meet DAWN criteria (NIHSS ≥ 10 points and infarct core volume < 31mL); Or NIHSS ≥ 20 points and infarct volume 31-51 mL)
- The mRS score before stroke is 0-1 points
- Written informed consent provided by the patients or their legal relatives
Ki nem vehet részt
- Currently participating in interventional clinical trials and using research drugs or medical devices
- Clinical manifestations suggest the presence of intracranial cerebral parenchymal hemorrhage or subarachnoid hemorrhage (even if imaging results are normal)
- During a stroke, accompanied by epilepsy, an accurate NIHSS score cannot be obtained
- Accompanied by coma or mental disorders, it may interfere with the assessment of neurological function
- History of allergy to iodinated contrast agents or history of anaphylactic shock
- During a stroke, there may be fever or active infections that require systemic treatment (such as active pulmonary tuberculosis)
- History of chronic heart failure with NYHA criteria>1; Uncontrolled hypertension (systolic blood pressure>180mmHg or diastolic blood pressure>105mmHg after standardized treatment), hypotension (systolic blood pressure ≤ 100mmHg after standardized treatment), unstable angina, myocardial infarction, or bypass or stent surgery within 6 months
- Accompanied by pulmonary diseases such as chronic obstructive pulmonary disease, tuberculosis, pneumonia, pneumothorax, atelectasis, pulmonary fibrosis, bronchopulmonary dysplasia, pleural effusion, acute respiratory distress syndrome, irregular breathing, etc
- Severe liver and kidney dysfunction, including but not limited to: cirrhosis, hepatic encephalopathy, ascites, renal failure or uremia (Ccr<25ml/min), hepatorenal syndrome, etc
- Patients with acute stroke within 48 hours after percutaneous cardiovascular and cerebrovascular intervention and major surgery
- CTA/MRA/DSA confirms moyamoya disease or moyamoya syndrome
- CT/MRI confirms the presence of intracranial hemorrhage
- Baseline blood glucose<50mg/dL (2.78mmol) or>400mg/dL (22.20mmol); *Acceptable fingertip blood glucose results
- Baseline platelet count<50 × 10\^9/L
- Recently (i.e. within 30 days prior to inclusion in the study), there has been a history of significant gastrointestinal or other clinically significant bleeding; Active bleeding, abnormal coagulation factors, or bleeding tendency (taking anticoagulant drugs with INR ≥ 3 or PT ≥ 3 × ULN; if the researcher believes that the subject has no coagulation dysfunction, there is no need to wait for coagulation test results to determine whether to enroll)
- General exclusion criteria:
- Pregnant or lactating women
- Participants may not be able to complete this study due to other reasons or may not be considered eligible for inclusion by the researchers; Image exclusion criteria:
- CTA/MRA/DSA shows excessive vessel curvature, which may hinder the delivery of interventional instruments
- Suspected cerebral vasculitis based on medical history and CTA/MRA/DSA
- Suspected aortic dissection based on medical history and CTA/MRA/DSA
- CTA/MRA/DSA confirmed multi vessel regional occlusion (such as bilateral anterior circulation or anterior/posterior circulation, extracranial carotid artery with intracranial tandem lesions), or clinical evidence of bilateral infarction or multi regional infarction
- CT/MRI confirms significant effect of midline shift
- CT/MRI confirms the presence of intracranial tumors (excluding small meningiomas)
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 80 év között vagy?
Helyszínek itt: Kína
- Affiliated Hospital of Xuzhou Medical UniversityXuzhou, KínaContact: Xunming Ji, MD, PhDRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
The primary objective of this study is to estimate the safety and effectiveness of selective intra-arterial hypothermic magnesium sulfate infusion after endovascular thrombectomy in patients with acute ischemic stroke.
A teljes eredeti leírásKevesebb
Addendum regarding phase 1 dosing implementation and planned phase 2 design:
This integrated phase 1/2 trial originally planned weight-individualized magnesium perfusate calculated as Target Mg (μmol/mL) = 0.6 × patient body weight. During phase 1 recruitment, no dedicated emergency pharmacy fast-track compound workflow existed for urgent EVT procedures, which would cause reperfusion delay if individualized mixing was performed intraoperatively. Therefore, a uniform fixed magnesium concentration of 20.29 mmol/L was adopted as a temporary operational solution for all 9 phase 1 participants, with dose escalation only performed by increasing total infusion volume (350/500/650 mL). For the upcoming phase 2 cohort, we will retain the fully safe 650 mL maximum infusion volume and conduct independent magnesium concentration escalation across six ascending tiers: 20.29, 22.54, 25.36, 28.98, 33.81, and 40.57 mmol/L. These concentrations are prepared by diluting the standard 5 g magnesium stock into 1000 mL, 900 mL, 800 mL, 700 mL, 600 mL, and 500 mL pre-cooled normal saline respectively. After defining the maximum tolerated magnesium concentration tier, the original weight-tailored compounding formula will be fully implemented for subsequent efficacy cohorts. All protocol adjustments have received institutional review board amendment approval.
A vizsgálat 5 csoportja
- Selective intra-arterial hypothermic magnesium sulfate infusion of low volumeA vizsgált kezelés
Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (350 ml). Note: In phase 1, all participants in these three volume-escalation arms received a uniform fixed-concentration perfusate of 20.29 mmol/L (5 g magnesium sulfate stock diluted into 1000 mL pre-cooled saline). Weight-tailored perfusate originally specified in registry could not be implemented due to absence of emergency pharmacy fast-track compounding workflow.
Kezelés: Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (350 ml).
- Selective intra-arterial hypothermic magnesium sulfate infusion of moderate volumeA vizsgált kezelés
Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (500 ml). Note: In phase 1, all participants in these three volume-escalation arms received a uniform fixed-concentration perfusate of 20.29 mmol/L (5 g magnesium sulfate stock diluted into 1000 mL pre-cooled saline). Weight-tailored perfusate originally specified in registry could not be implemented due to absence of emergency pharmacy fast-track compounding workflow.
Kezelés: Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (500 ml).
- Selective intra-arterial hypothermic magnesium sulfate infusion of high volumnA vizsgált kezelés
Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (650 ml). Note: In phase 1, all participants in these three volume-escalation arms received a uniform fixed-concentration perfusate of 20.29 mmol/L (5 g magnesium sulfate stock diluted into 1000 mL pre-cooled saline). Weight-tailored perfusate originally specified in registry could not be implemented due to absence of emergency pharmacy fast-track compounding workflow.
Kezelés: Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (650 ml).
- ControlSzínlelt kezelés, összehasonlításként
Endovascular thrombectomy alone
Kezelés: Endovascular thrombectomy
- Phase 2 Fixed-Volume Concentration-Escalation CohortA vizsgált kezelés
Intra-arterial selective cooling magnesium sulfate perfusate. All subjects receive a fixed maximum total infusion volume of 650 mL. Six ascending magnesium concentration tiers will be tested sequentially: 20.29 mmol/L, 22.54 mmol/L, 25.36 mmol/L, 28.98 mmol/L, 33.81 mmol/L, and 40.57 mmol/L. Each concentration is prepared by diluting one 5 g/10 mL magnesium sulfate heptahydrate stock vial into 1000 mL, 900 mL, 800 mL, 700 mL, 600 mL, or 500 mL pre-cooled 4 °C normal saline, respectively. After identifying the maximum tolerated magnesium concentration, the original registry-specified weight-individualized compounding formula will be implemented for subsequent efficacy-focused cohorts. This phase is enrolling participants.
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Selective Intra-arterial Hypothermic Magnesium Sulfate Infusion in Combination With Endovascular Thrombectomy in Acute Ischemic Stroke: A Phase 1/2 Randomized Clinical Trial
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
- Illeszkedési kérdések
- Forrás: NCT07163299: ki vehet részt
- A regiszteradat frissítve
- 2026. november 12.