Hospital Universitario La Paz
Madrid, 28046, Spain
NCT Number: NCT05871502
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Madrid, 28046, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: During the mechanical thrombectomy procedure
Peak blood glucose values during the mechanical thrombectomy procedure.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 2 years
Insulin treatment received by clinical practice (route of administration and dose)
Time frame: 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 frame: During the time the device is worn, up to 15 days
Mean blood glucose
Time frame: Through study completion, an average of 2 years
Number of mechanical thrombectomy passes (includes aspirations and stent-retriever passes).
Time frame: 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))
Time frame: During reperfusion procedure
Arterial blood pressure in the emergencies and at the time of reperfusion.
Time frame: At 24 hours
Infarct size at 24 hours (assessed by a radiologist who will be unaware of blood glucose monitoring data)
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: At 90 days
Distribution of scores on the modified Rankin scale at 90 days (shift analysis).
Time frame: At 3 months
Mortality at 3 months
Time frame: 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.
Time frame: Through study completion, an average of 2 years
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.
Time frame: Before entering the study
Platelet antiaggregants, anticoagulants, antihypertensives, antidiabetics and lipid-lowering agents.
Time frame: During the duration of the stroke
Date of symptom onset (or last asymptomatic in patients with unknown stroke onset), subtype of stroke and treatment with intravenous thrombolysis.
Time frame: At the baseline visit
Baseline ASPECTS (degree of collateral circulation and perfusion)
Instituto de Investigación Hospital Universitario La Paz
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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