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

Not Applicable

Recruiting

• Conditions: Cerebral Infarction

• Registration Number: NCT05871502
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-13
• Study First Submitted: 2023-04-14
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-12
• Last Update Submitted: 2023-05-12
• Study First Posted: 2023-05-23
• Last Update Posted: 2023-05-23
• Primary Completion: 2025-04-13
• Study Completion: 2025-04-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 mechanical thrombectomy passes	Through study completion, an average of 2 years	Number of mechanical thrombectomy passes (includes aspirations and stent-retriever passes).
Additional data of the subcutaneous blood glucose monitoring device	During the time the device is worn, up to 15 days	Mean blood glucose
Infarct size	At 24 hours	Infarct size at 24 hours (assessed by a radiologist who will be unaware of blood glucose monitoring data)
Peak blood glucose values	During the mechanical thrombectomy procedure	Peak blood glucose values during the mechanical thrombectomy procedure.
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.
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
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.
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.
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).
Mortality	At 3 months	Mortality at 3 months
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.
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).
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.

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain