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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cerebral Infarction
• Intervention / Treatment: Device: Subcutaneous blood glucose monitoring device

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Subcutaneous 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).

Device: Subcutaneous 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2023
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Infarction; Necrosis; Ischemia; Stroke; Pathological Conditions, Signs and Symptoms; Cerebral Infarction
• Other Study ID Numbers: GLIAS-TM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No