Cerebral Infarction
Conditions
Brief summary
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.
Interventions
DEVICESubcutaneous blood glucose monitoring 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.
Sponsors
Instituto de Investigación Hospital Universitario La Paz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose levels at the time of reperfusion | 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. |
| Modified Rankin scale at 3 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Peak blood glucose values | During the mechanical thrombectomy procedure | Peak blood glucose values during the mechanical thrombectomy procedure. |
| Blood glucose values above 155 mg/dL | 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 |
| Time in range 110-154 mg/dL of blood glucose values | 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 |
| Proportion of patients receiving insulin treatment | 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 |
| Dose of insulin treatment received by clinical practice | Through study completion, an average of 2 years | Insulin treatment received by clinical practice (route of administration and dose) |
| Number of subcutaneous blood glucose monitoring devices with technical failures | 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. |
| Additional data of the subcutaneous blood glucose monitoring device | During the time the device is worn, up to 15 days | Mean blood glucose |
| Number of mechanical thrombectomy passes | Through study completion, an average of 2 years | Number of mechanical thrombectomy passes (includes aspirations and stent-retriever passes). |
| Degree of recanalization | 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)) |
| Arterial blood pressure | During reperfusion procedure | Arterial blood pressure in the emergencies and at the time of reperfusion. |
| Infarct size | At 24 hours | Infarct size at 24 hours (assessed by a radiologist who will be unaware of blood glucose monitoring data) |
| Hemorrhagic transformation | 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. |
| Number of symptomatic hemorrhagic transformation | 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. |
| National Institutes of Healt Stroke Scale score | 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). |
| Neurological or systemic complications | 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. |
| Distribution of scores on the modified Rankin scale | At 90 days | Distribution of scores on the modified Rankin scale at 90 days (shift analysis). |
| Mortality | At 3 months | Mortality at 3 months |
| Presence of biomarkers of ischemia-reperfusion injury | 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. |
Countries
Spain
Outcome results
None listed