Clinical trial NCT05871502: Glycemia and Ischemia Reperfusion Brain Injury in Patients With Acute Cerebral Infarction Treated With Mechanical Thrombectomy
Official title: Glycemia and Ischemia Reperfusion Brain Injury in Patients With Acute Cerebral Infarction Treated With Mechanical Thrombectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Infarction
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Blood glucose levels at the time of reperfusion
timeFrame: During reperfusion procedure
measure: Modified Rankin scale at 3 months
timeFrame: From baseline to month 3
Secondary outcomes:
measure: Peak blood glucose values
timeFrame: During the mechanical thrombectomy procedure
measure: Blood glucose values above 155 mg/dL
timeFrame: The entire time from arrival at the emergency room until completion of the arterial recanalization procedure.
measure: Time in range 110-154 mg/dL of blood glucose values
timeFrame: From arrival at the emergency department to recanalization, during the first 24 hours and during hospital stay
measure: Proportion of patients receiving insulin treatment
timeFrame: During the first 24 hours from the onset of stroke symptoms
measure: Dose of insulin treatment received by clinical practice
timeFrame: Through study completion, an average of 2 years
measure: Number of subcutaneous blood glucose monitoring devices with technical failures
timeFrame: Through study completion, an average of 2 years
measure: Additional data of the subcutaneous blood glucose monitoring device
timeFrame: During the time the device is worn, up to 15 days
measure: Number of mechanical thrombectomy passes
timeFrame: Through study completion, an average of 2 years
measure: Degree of recanalization
timeFrame: Through study completion, an average of 2 years
measure: Arterial blood pressure
timeFrame: During reperfusion procedure
measure: Infarct size
timeFrame: At 24 hours
measure: Hemorrhagic transformation
timeFrame: At 24 hours
measure: Number of symptomatic hemorrhagic transformation
timeFrame: During a symptomatic hemorrhagic transformation
measure: National Institutes of Healt Stroke Scale score
timeFrame: At 24 hours and at 3 months
measure: Neurological or systemic complications
timeFrame: During follow-up period, up to 3 months
measure: Distribution of scores on the modified Rankin scale
timeFrame: At 90 days
measure: Mortality
timeFrame: At 3 months
measure: Presence of biomarkers of ischemia-reperfusion injury
timeFrame: During reperfusion procedure and 24 hours later
Other outcomes:
measure: Demographic data:
timeFrame: Through study completion, an average of 2 years
measure: Number of previous pharmacological treatments
timeFrame: Before entering the study
measure: Stroke data
timeFrame: During the duration of the stroke
measure: Neuroimaging data
timeFrame: At the baseline visit
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References: