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

Primary Purpose

Cerebral Infarction

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Subcutaneous blood glucose monitoring device
Sponsored by
Instituto de Investigación Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cerebral Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Universitario La PazRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subcutaneous blood glucose monitoring device

Arm 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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Peak blood glucose values
Peak blood glucose values during the mechanical thrombectomy procedure.
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
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
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
Dose of insulin treatment received by clinical practice
Insulin treatment received by clinical practice (route of administration and dose)
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.
Additional data of the subcutaneous blood glucose monitoring device
Mean blood glucose
Number of mechanical thrombectomy passes
Number of mechanical thrombectomy passes (includes aspirations and stent-retriever passes).
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))
Arterial blood pressure
Arterial blood pressure in the emergencies and at the time of reperfusion.
Infarct size
Infarct size at 24 hours (assessed by a radiologist who will be unaware of blood glucose monitoring data)
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.
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.
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).
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.
Distribution of scores on the modified Rankin scale
Distribution of scores on the modified Rankin scale at 90 days (shift analysis).
Mortality
Mortality at 3 months
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.

Full Information

First Posted
April 14, 2023
Last Updated
May 12, 2023
Sponsor
Instituto de Investigación Hospital Universitario La Paz
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1. Study Identification

Unique Protocol Identification Number
NCT05871502
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2023 (Actual)
Primary Completion Date
April 13, 2025 (Anticipated)
Study Completion Date
April 13, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Infarction

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subcutaneous blood glucose monitoring device
Arm Type
Experimental
Arm 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).
Intervention Type
Device
Intervention Name(s)
Subcutaneous blood glucose monitoring device
Intervention 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). 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.
Primary Outcome Measure Information:
Title
Blood glucose levels at the time of reperfusion
Description
Blood glucose levels at the time of reperfusion in patients achieving TICI-2b, TICI-2c or TICI3 recanalization pattern after mechanical thrombectomy.
Time Frame
During reperfusion procedure
Title
Modified Rankin scale at 3 months
Description
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
From baseline to month 3
Secondary Outcome Measure Information:
Title
Peak blood glucose values
Description
Peak blood glucose values during the mechanical thrombectomy procedure.
Time Frame
During the mechanical thrombectomy procedure
Title
Blood glucose values above 155 mg/dL
Description
Total time with blood glucose values above 155 mg/dL from arrival at the emergency department to arterial recanalization
Time Frame
The entire time from arrival at the emergency room until completion of the arterial recanalization procedure.
Title
Time in range 110-154 mg/dL of blood glucose values
Description
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
From arrival at the emergency department to recanalization, during the first 24 hours and during hospital stay
Title
Proportion of patients receiving insulin treatment
Description
Proportion of patients receiving insulin treatment for post-stroke hyperglycemia, during the first 24h from the onset of stroke symptoms
Time Frame
During the first 24 hours from the onset of stroke symptoms
Title
Dose of insulin treatment received by clinical practice
Description
Insulin treatment received by clinical practice (route of administration and dose)
Time Frame
Through study completion, an average of 2 years
Title
Number of subcutaneous blood glucose monitoring devices with technical failures
Description
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
Through study completion, an average of 2 years
Title
Additional data of the subcutaneous blood glucose monitoring device
Description
Mean blood glucose
Time Frame
During the time the device is worn, up to 15 days
Title
Number of mechanical thrombectomy passes
Description
Number of mechanical thrombectomy passes (includes aspirations and stent-retriever passes).
Time Frame
Through study completion, an average of 2 years
Title
Degree of recanalization
Description
Degree of recanalization according to the TICI classification in the final angiogram (from no perfusion (grade 0) to complete perfusion (grade 3))
Time Frame
Through study completion, an average of 2 years
Title
Arterial blood pressure
Description
Arterial blood pressure in the emergencies and at the time of reperfusion.
Time Frame
During reperfusion procedure
Title
Infarct size
Description
Infarct size at 24 hours (assessed by a radiologist who will be unaware of blood glucose monitoring data)
Time Frame
At 24 hours
Title
Hemorrhagic transformation
Description
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
At 24 hours
Title
Number of symptomatic hemorrhagic transformation
Description
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
During a symptomatic hemorrhagic transformation
Title
National Institutes of Healt Stroke Scale score
Description
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
At 24 hours and at 3 months
Title
Neurological or systemic complications
Description
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
During follow-up period, up to 3 months
Title
Distribution of scores on the modified Rankin scale
Description
Distribution of scores on the modified Rankin scale at 90 days (shift analysis).
Time Frame
At 90 days
Title
Mortality
Description
Mortality at 3 months
Time Frame
At 3 months
Title
Presence of biomarkers of ischemia-reperfusion injury
Description
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
During reperfusion procedure and 24 hours later
Other Pre-specified Outcome Measures:
Title
Demographic data:
Description
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
Through study completion, an average of 2 years
Title
Number of previous pharmacological treatments
Description
Platelet antiaggregants, anticoagulants, antihypertensives, antidiabetics and lipid-lowering agents.
Time Frame
Before entering the study
Title
Stroke data
Description
Date of symptom onset (or last asymptomatic in patients with unknown stroke onset), subtype of stroke and treatment with intravenous thrombolysis.
Time Frame
During the duration of the stroke
Title
Neuroimaging data
Description
Baseline ASPECTS (degree of collateral circulation and perfusion)
Time Frame
At the baseline visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Blanca Fuentes Gimeno, MD
Phone
+34 91 727 72 55
Email
blanca.fuentes@salud.madrid.org
Facility Information:
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blanca Fuentes Gimeno, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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