Cerebral InfarctionNCT05871502
Glycemia and Ischemia Reperfusion Brain Injury in Patients With Acute Cerebral Infarction Treated With Mechanical Thrombectomy
A study testing Subcutaneous blood glucose monitoring device in people with Cerebral Infarction, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- Subcutaneous blood glucose monitoring device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteSpain
- Study dates
- 13 Apr 2023to 10 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cerebral Infarction
- Being tested
- Subcutaneous blood glucose monitoring device
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous blood glucose monitoring deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous blood glucose monitoring device | Experimental | 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). Receives: Device: Subcutaneous blood glucose monitoring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During reperfusion procedure
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.
Measured: From baseline to month 3
Secondary outcomes (18)
Peak blood glucose values
Peak blood glucose values during the mechanical thrombectomy procedure.
Measured: 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
Measured: The entire time from arrival at the emergency room until completion of the arterial recanalization procedure.
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
Measured: From arrival at the emergency department to recanalization, during the first 24 hours and 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
Measured: During the first 24 hours 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)
Measured: Through study completion, an average of 2 years
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.
Measured: Through study completion, an average of 2 years
Additional data of the subcutaneous blood glucose monitoring device
Mean blood glucose
Measured: During the time the device is worn, up to 15 days
Number of mechanical thrombectomy passes
Number of mechanical thrombectomy passes (includes aspirations and stent-retriever passes).
Measured: Through study completion, an average of 2 years
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))
Measured: Through study completion, an average of 2 years
Arterial blood pressure
Arterial blood pressure in the emergencies and at the time of reperfusion.
Measured: During reperfusion procedure
Infarct size
Infarct size at 24 hours (assessed by a radiologist who will be unaware of blood glucose monitoring data)
Measured: At 24 hours
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.
Measured: At 24 hours
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.
Measured: During a symptomatic hemorrhagic transformation
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).
Measured: At 24 hours and at 3 months
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.
Measured: During follow-up period, up to 3 months
Distribution of scores on the modified Rankin scale
Distribution of scores on the modified Rankin scale at 90 days (shift analysis).
Measured: At 90 days
Mortality
Mortality at 3 months
Measured: 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.
Measured: During reperfusion procedure and 24 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start13 Apr 2023
- Primary completion10 Jul 2026
- Study completion10 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871502
- Sponsor's protocol ID
- GLIAS-TM
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hervas C, Peiroten I, Gonzalez L, Alonso de Lecinana M, Alonso-Lopez E, Casado L, De Celis-Ruiz E, Fernandez Prieto AF, Frutos R, Gallego-Ruiz R, Gonzalez Perez de Villar N, Gutierrez-Fernandez M, Navia P, Otero-Ortega L, Pozo-Novoa J, Rigual R, Rodriguez-Pardo J, Ruiz G, Fuentes B. Glycaemia and ischaemia-reperfusion brain injury in patients with ischaemic stroke treated with mechanical thrombectomy (GLIAS-MT): an observational, unicentric, prospective study protocol. BMJ Open. 2024 Aug 7;14(8):e086745. doi: 10.1136/bmjopen-2024-086745.
PubMed 39117402
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemia and Ischemia Reperfusion Brain Injury in Patients With Acute Cerebral Infarction Treated With Mechanical Thrombectomy
- ClinicalTrials.gov ID
- NCT05871502
- Acronym / sponsor ID
- GLIAS-TM
- Conditions
- Cerebral Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 10 Jul 2026 (actual)
- Study completion
- 10 Jul 2026 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous blood glucose monitoring device | Experimental | Device: Subcutaneous blood glucose monitoring deviceAfter 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcutaneous blood glucose monitoring deviceAfter 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. | Device | Subcutaneous blood glucose monitoring device |
Primary outcome
Blood glucose levels at the time of reperfusion
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.
Modified Rankin scale at 3 months
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.
18 secondary outcomes
Peak blood glucose values
Time frame: During the mechanical thrombectomy procedure
Blood glucose values above 155 mg/dL
Time frame: The entire time from arrival at the emergency room until completion of the arterial recanalization procedure.
Time in range 110-154 mg/dL of blood glucose values
Time frame: From arrival at the emergency department to recanalization, during the first 24 hours and during hospital stay
Proportion of patients receiving insulin treatment
Time frame: During the first 24 hours from the onset of stroke symptoms
Dose of insulin treatment received by clinical practice
Time frame: Through study completion, an average of 2 years
Number of subcutaneous blood glucose monitoring devices with technical failures
Time frame: Through study completion, an average of 2 years
Additional data of the subcutaneous blood glucose monitoring device
Time frame: During the time the device is worn, up to 15 days
Number of mechanical thrombectomy passes
Time frame: Through study completion, an average of 2 years
Degree of recanalization
Time frame: Through study completion, an average of 2 years
Arterial blood pressure
Time frame: During reperfusion procedure
Infarct size
Time frame: At 24 hours
Hemorrhagic transformation
Time frame: At 24 hours
Number of symptomatic hemorrhagic transformation
Time frame: During a symptomatic hemorrhagic transformation
National Institutes of Healt Stroke Scale score
Time frame: At 24 hours and at 3 months
Neurological or systemic complications
Time frame: During follow-up period, up to 3 months
Distribution of scores on the modified Rankin scale
Time frame: At 90 days
Mortality
Time frame: At 3 months
Presence of biomarkers of ischemia-reperfusion injury
Time frame: During reperfusion procedure and 24 hours later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Derived from this study: PubMed 39117402Hervas C, Peiroten I, Gonzalez L, Alonso de Lecinana M, Alonso-Lopez E, Casado L, De Celis-Ruiz E, Fernandez Prieto AF, Frutos R, Gallego-Ruiz R, Gonzalez Perez de Villar N, Gutierrez-Fernandez M, Navia P, Otero-Ortega L, Pozo-Novoa J, Rigual R, Rodriguez-Pardo J, Ruiz G, Fuentes B. Glycaemia and ischaemia-reperfusion brain injury in patients with ischaemic stroke treated with mechanical thrombectomy (GLIAS-MT): an observational, unicentric, prospective study protocol. BMJ Open. 2024 Aug 7;14(8):e086745. doi: 10.1136/bmjopen-2024-086745.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous blood glucose monitoring device in people with Cerebral Infarction, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose levels at the time of reperfusion (time frame: During reperfusion procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05871502, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.