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

Instituto de Investigación Hospital Universitario La Paz

Status: Enrolling

Conditions: Cerebral Infarction

Treatments: Device: Subcutaneous blood glucose monitoring device

Study type: Interventional

Funder types: Other

Identifiers

NCT05871502

GLIAS-TM

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Subcutaneous blood glucose monitoring device

Experimental group

Description:

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).

Treatment:

Device: Subcutaneous blood glucose monitoring device