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

NCT05871502 | Active Not Recruiting

• 1 other identifier: GLIAS-TM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Infarction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• 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.

• 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

• Proportion of patients receiving insulin treatment

  During the first 24 hours from the onset of stroke symptoms

• Dose of insulin treatment received by clinical practice

  Through study completion, an average of 2 years

Other Outcomes (4)

• Demographic data:

  Through study completion, an average of 2 years

• Number of previous pharmacological treatments

  Before entering the study

• Stroke data

  During the duration of the stroke

Study Arms (1)

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).

Device: Subcutaneous blood glucose monitoring device

Interventions

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.

Subcutaneous blood glucose monitoring device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Modified Rankin Scale (mRS) score prior to stroke of 0-1.
• Signature of informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Related Publications (1)

• 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.

  PMID: 39117402 DERIVED

MeSH Terms

Conditions

Cerebral Infarction

Condition Hierarchy (Ancestors)

Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 23, 2023
• Study Start: April 13, 2023
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)