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

Cerebral Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05871502
• Other study ID #: GLIAS-TM
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2023
• Est. completion date: April 13, 2025

Study information

• Verified date: May 2023
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: Blanca Fuentes Gimeno, MD
• Phone: +34 91 727 72 55
• Email: blanca.fuentes[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 13, 2025
• Est. primary completion date: April 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Cerebral Infarction
• Infarction
• Ischemia

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Number of previous pharmacological treatments	Platelet antiaggregants, anticoagulants, antihypertensives, antidiabetics and lipid-lowering agents.	Before entering the study
Other	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
Other	Neuroimaging data	Baseline ASPECTS (degree of collateral circulation and perfusion)	At the baseline visit
Primary	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
Primary	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	Peak blood glucose values	Peak blood glucose values during the mechanical thrombectomy procedure.	During the mechanical thrombectomy procedure
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Additional data of the subcutaneous blood glucose monitoring device	Mean blood glucose	During the time the device is worn, up to 15 days
Secondary	Number of mechanical thrombectomy passes	Number of mechanical thrombectomy passes (includes aspirations and stent-retriever passes).	Through study completion, an average of 2 years
Secondary	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
Secondary	Arterial blood pressure	Arterial blood pressure in the emergencies and at the time of reperfusion.	During reperfusion procedure
Secondary	Infarct size	Infarct size at 24 hours (assessed by a radiologist who will be unaware of blood glucose monitoring data)	At 24 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Distribution of scores on the modified Rankin scale	Distribution of scores on the modified Rankin scale at 90 days (shift analysis).	At 90 days
Secondary	Mortality	Mortality at 3 months	At 3 months
Secondary	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