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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcutaneous blood glucose monitoring device | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose levels at the time of reperfusion | Blood glucose levels at the time of reperfusion in patients achieving TICI-2b, TICI-2c or TICI3 recanalization pattern after mechanical thrombectomy. | During reperfusion procedure |
| Modified Rankin scale at 3 months | 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. | From baseline to month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak blood glucose values | Peak blood glucose values during the mechanical thrombectomy procedure. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic data: | 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. | Through study completion, an average of 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39117402 | Derived | Hervas C, Peiroten I, Gonzalez L, Alonso de Lecinana M, Alonso-Lopez E, Casado L, De Celis-Ruiz E, Fernandez Prieto AF, Frutos R, Gallego-Ruiz R, Gonzalez Perez de Villar N, Gutierrez-Fernandez M, Navia P, Otero-Ortega L, Pozo-Novoa J, Rigual R, Rodriguez-Pardo J, Ruiz G, Fuentes B. Glycaemia and ischaemia-reperfusion brain injury in patients with ischaemic stroke treated with mechanical thrombectomy (GLIAS-MT): an observational, unicentric, prospective study protocol. BMJ Open. 2024 Aug 7;14(8):e086745. doi: 10.1136/bmjopen-2024-086745. |
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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). Those patients with blood glucose levels >155 mg/dl will receive insulin at the discretion of the physician responsible for the patient, following the local protocols for the management of hyperglycemia in hospitalized patients and the guidelines for the management of hyperglycemia in patients with acute stroke.
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|
| 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 | 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 | 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) | 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. | Through study completion, an average of 2 years |
| Additional data of the subcutaneous blood glucose monitoring device | Mean blood glucose | 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). | 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)) | Through study completion, an average of 2 years |
| Arterial blood pressure | Arterial blood pressure in the emergencies and at the time of reperfusion. | During reperfusion procedure |
| Infarct size | Infarct size at 24 hours (assessed by a radiologist who will be unaware of blood glucose monitoring data) | 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. | 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. | 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). | 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. | 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). | At 90 days |
| Mortality | Mortality at 3 months | 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. | During reperfusion procedure and 24 hours later |
| Number of previous pharmacological treatments |
Platelet antiaggregants, anticoagulants, antihypertensives, antidiabetics and lipid-lowering agents. |
| Before entering the study |
| Stroke data | Date of symptom onset (or last asymptomatic in patients with unknown stroke onset), subtype of stroke and treatment with intravenous thrombolysis. | During the duration of the stroke |
| Neuroimaging data | Baseline ASPECTS (degree of collateral circulation and perfusion) | At the baseline visit |
| ID | Term |
|---|---|
| D002544 | Cerebral Infarction |
| ID | Term |
|---|---|
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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