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NCT Number: NCT05871502

Glycemia and Ischemia Reperfusion Brain Injury in Patients With Acute Cerebral Infarction Treated With Mechanical Thrombectomy

Postictus hyperglycemia is associated with an accelerated transformation of the ischemic penumbra into an infarct area, with increased infarct size, worse recanalization, reduced cerebral perfusion, increased ischemia reperfusion damage, and worse outcome. Furthermore, when perfusion is reinstated, hyperglycemia causes secondary tissue damage through an increase in ischemic reperfusion damage. Thus, those patients with glycemia values < 155 mg/dL during mechanical thrombectomy, and especially at the time of reperfusion, will have greater ischemia-reperfusion damage, showing a different profile in miRNA expression, with better neurological and functional outcomes and higher risk of hemorrhagic transformation and cerebral edema.

The main objective of the study is to evaluate the association between glycemia values at the time of reperfusion and stroke recovery at 3 months in patients with acute cerebral infarction treated with mechanical thrombectomy.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario La Paz

Madrid, 28046, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women over 18 years of age
  • Neuroimaging studies such as computed tomography (CT), angio-CT or angio-MRI compatible with the diagnosis of acute cerebral infarction due to occlusion of a large vessel of the anterior circulation, including the internal carotid artery (intra- or extracranial) or middle cerebral artery (M1 or M2 segments).
  • Indication of mechanical thrombectomy according to clinical practice.
  • Inclusion of the patient in the study before the endovascular procedure.
  • Modified Rankin Scale (mRS) score prior to stroke of 0-1.
  • Signature of informed consent.

Exclusion criteria

  • CT, angio-CT or angio-MRI showing posterior circulation occlusion.
  • Severe or life-threatening concomitant disease that precludes follow-up for 3 months after stroke,
  • Alcohol or drug abuse
  • Participation in a therapeutic clinical trial.

Treatment and study plan

Subcutaneous blood glucose monitoring device

Device

After signing the informed consent and before the start of the endovascular procedure, a subcutaneous blood glucose monitoring device will be implanted, which will be removed on day 15 (or at hospital discharge if this takes place before 15 days). This device will be selected from those currently available on the market, with CE marking, and with previous studies documenting its safety and feasibility for radiological procedures.

Primary outcomes

  1. Blood glucose levels at the time of reperfusion

    Time frame: During reperfusion procedure

    Blood glucose levels at the time of reperfusion in patients achieving TICI-2b, TICI-2c or TICI3 recanalization pattern after mechanical thrombectomy.

  2. Modified Rankin scale at 3 months

    Time frame: From baseline to month 3

    Its dichotomized assessment (Modified Rankin Scale or mRS 0-2 indicating good functional recovery and 3-6 indicating death or dependence) is commonly used in acute stroke studies.

Secondary outcomes

  1. Peak blood glucose values

    Time frame: During the mechanical thrombectomy procedure

    Peak blood glucose values during the mechanical thrombectomy procedure.

  2. Blood glucose values above 155 mg/dL

    Time frame: The entire time from arrival at the emergency room until completion of the arterial recanalization procedure.

    Total time with blood glucose values above 155 mg/dL from arrival at the emergency department to arterial recanalization

  3. Time in range 110-154 mg/dL of blood glucose values

    Time frame: From arrival at the emergency department to recanalization, during the first 24 hours and during hospital stay

    Time in range 110-154 mg/dL of blood glucose values: (a) from arrival at the emergency department to recanalization; (b) during the first 24 h; and (c) during hospital stay

  4. Proportion of patients receiving insulin treatment

    Time frame: During the first 24 hours from the onset of stroke symptoms

    Proportion of patients receiving insulin treatment for post-stroke hyperglycemia, during the first 24h from the onset of stroke symptoms

  5. Dose of insulin treatment received by clinical practice

    Time frame: Through study completion, an average of 2 years

    Insulin treatment received by clinical practice (route of administration and dose)

  6. Number of subcutaneous blood glucose monitoring devices with technical failures

    Time frame: Through study completion, an average of 2 years

    Number of subcutaneous blood glucose monitoring devices with technical failures (absence or interruption of readings) or requiring replacement due to involuntary removal of the device or inadequate implantation.

  7. Additional data of the subcutaneous blood glucose monitoring device

    Time frame: During the time the device is worn, up to 15 days

    Mean blood glucose

  8. Number of mechanical thrombectomy passes

    Time frame: Through study completion, an average of 2 years

    Number of mechanical thrombectomy passes (includes aspirations and stent-retriever passes).

  9. Degree of recanalization

    Time frame: Through study completion, an average of 2 years

    Degree of recanalization according to the TICI classification in the final angiogram (from no perfusion (grade 0) to complete perfusion (grade 3))

  10. Arterial blood pressure

    Time frame: During reperfusion procedure

    Arterial blood pressure in the emergencies and at the time of reperfusion.

  11. Infarct size

    Time frame: At 24 hours

    Infarct size at 24 hours (assessed by a radiologist who will be unaware of blood glucose monitoring data)

  12. Hemorrhagic transformation

    Time frame: At 24 hours

    Hemorrhagic transformation at 24 hours (assessed by a radiologist who will be unaware of blood glucose monitoring data). It will be categorized into four types: (1) hemorrhagic infarction type 1 (HI-1): small petechiae at the edges of the infarcted area; (2) hemorrhagic infarction type 2 (HI-2): confluent petechiae in the infarct area without mass effect; (3) parenchymal hematoma type 1 (HP-1): hematoma occupying ≤ 30% of the infarct area, with discrete mass effect; and (4) parenchymal hematoma type 2 (HP-2): hematoma occupying more than 30% of the infarct area, with evident mass effect.

  13. Number of symptomatic hemorrhagic transformation

    Time frame: During a symptomatic hemorrhagic transformation

    Symptomatic hemorrhagic transformation defined as computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of any type of hemorrhage that is accompanied by neurological deterioration ≥ 4 points on the National Institutes of Healt Stroke Scale scale from baseline or leading to death.

  14. National Institutes of Healt Stroke Scale score

    Time frame: At 24 hours and at 3 months

    National Institutes of Healt Stroke Scale score at 24 hours, at hospital discharge, and at 3 months (scores range from 0 to 42, with higher scores indicating more severe neurological deficit).

  15. Neurological or systemic complications

    Time frame: During follow-up period, up to 3 months

    Neurological or systemic complications during follow-up. The following complications will be systematically assessed at each visit: coma, seizures, early neurological deterioration, cerebral edema, recurrent stroke, acute coronary syndrome, pulmonary thromboembolism, respiratory infection, urinary tract infection, sepsis, local hematoma or infection at the insertion site of the subcutaneous blood glucose monitor. Any other complication that is referred or detected during follow-up will also be recorded.

  16. Distribution of scores on the modified Rankin scale

    Time frame: At 90 days

    Distribution of scores on the modified Rankin scale at 90 days (shift analysis).

  17. Mortality

    Time frame: At 3 months

    Mortality at 3 months

  18. Presence of biomarkers of ischemia-reperfusion injury

    Time frame: During reperfusion procedure and 24 hours later

    Biomarkers of ischemia-reperfusion injury: miR-29b, miR-339, miR-15a, miR-100 and miR-424. Samples will be collected at the time of reperfusion and 24 hours later.

Other outcomes

  1. Demographic data:

    Time frame: Through study completion, an average of 2 years

    Age, sex, race, weight, height, previous diagnosis or treatment for any of the following conditions: diabetes, hypertension, dyslipidemia, coronary artery disease, atrial fibrillation, metabolic syndrome, chronic kidney disease (eGFR < 60 ml/min/1.73m2), smoking or alcohol abuse.

  2. Number of previous pharmacological treatments

    Time frame: Before entering the study

    Platelet antiaggregants, anticoagulants, antihypertensives, antidiabetics and lipid-lowering agents.

  3. Stroke data

    Time frame: During the duration of the stroke

    Date of symptom onset (or last asymptomatic in patients with unknown stroke onset), subtype of stroke and treatment with intravenous thrombolysis.

  4. Neuroimaging data

    Time frame: At the baseline visit

    Baseline ASPECTS (degree of collateral circulation and perfusion)

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 23, 2023
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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