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

Peak blood glucose values

Peak blood glucose values during the mechanical thrombectomy procedure.

Time frame: During the mechanical thrombectomy procedure

Blood glucose values above 155 mg/dL

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

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

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

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

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

Proportion of patients receiving insulin treatment

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

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

Dose of insulin treatment received by clinical practice

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

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

Number of subcutaneous blood glucose monitoring devices with technical failures

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.

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

Additional data of the subcutaneous blood glucose monitoring device

Mean blood glucose

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

Number of mechanical thrombectomy passes

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

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

Degree of recanalization

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

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

Arterial blood pressure

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

Time frame: During reperfusion procedure

Infarct size

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

Time frame: At 24 hours

Hemorrhagic transformation

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.

Time frame: At 24 hours

Number of 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.

Time frame: During a symptomatic hemorrhagic transformation

National Institutes of Healt Stroke Scale score

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).

Time frame: At 24 hours and at 3 months

Neurological or systemic complications

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.

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

Distribution of scores on the modified Rankin scale

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

Time frame: At 90 days

Mortality

Mortality at 3 months

Time frame: At 3 months

Presence of biomarkers of ischemia-reperfusion injury

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.

Time frame: During reperfusion procedure and 24 hours later