Brain Ischemia, Glycemic Variability, Hyperglycemia
Conditions
Brief summary
This is a multicenter observational clinical study in patients with acute ischemic stroke. The main objective is to evaluate the impact of glycemic variability (GV) on stroke outcome (mortality, functional recovery) of patients with acute ischemic stroke. Glycemic variability will be assessed using a subcutaneous device for continuous glycaemia motorization during 96 hours; also capillar glycaemia will be measured every 6 hours.
Detailed description
10 different hospitals in Spain will participate in this study, recruiting a total of 340 patients. Once the informed consent form is signed, the subcutaneous device for continuous glycaemia motorization will be implanted and demographic, comorbidities and treatments of every patient will be registered. During the first 96 hours, capillar glycaemia, NIHSS scale, HbA1C levels, cerebral recanalization treatment and glycaemia correcting treatments will also be reported. In the following days (7, 30 and 90 days after stroke) modified Rankin Scale, NIHSS scale and stroke secondary prevention treatments will be evaluated. At day 90, a new measure of HbA1C will be done.
Interventions
None listed
Sponsors
Instituto de Investigación Hospital Universitario La Paz
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \> 18 years old * Inclusion less than 24 hours from ischemic stroke * Functional independence prior to stroke * Signed informed consent
Exclusion criteria
* Transient cerebral ischemia * Prevision of need to perform a magnetic resonance within the first 96 hours from inclusion * Concomitant severe or deadly disease that may interfere with study follow-up during 3 months from stroke * Current drug or alcohol abuse that may interfere with study follow-up * Participation in a clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic variation impact in mortality of patients with acute ischemic stroke | 3 months from stroke | Intrahospital mortality |
| Glycemic variation impact in functional status of patients with acute ischemic stroke | 3 months from stroke | Modified Rankin Scale. This scale measures degree of disability/dependence after a stroke. 0- No symptoms 1. No significant disability despite symptoms; able to perform all usual duties and activities. 2. Slight disability; unable to perform all previous activities but able to look after own affairs without assistance. 3. Moderate disability; requires some help but able to walk without assistance. 4. Moderate severe disability; unable to walk without assistance an unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requires constant nursing care and attention. 6. Death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of glycemic variation in mortality in diabetic patients with acute ischemic stroke. | 3 months from stroke | Intrahospital mortality |
| Impact of glycemic variation in functional status in diabetic patients with acute ischemic stroke. | 3 months from stroke | Modified Rankin Scale. This scale measures degree of disability/dependence after a stroke. 0- No symptoms 1. No significant disability despite symptoms; able to perform all usual duties and activities. 2. Slight disability; unable to perform all previous activities but able to look after own affairs without assistance. 3. Moderate disability; requires some help but able to walk without assistance. 4. Moderate severe disability; unable to walk without assistance an unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requires constant nursing care and attention. 6. Death |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORBlanca Fuentes Gimeno
Hospital Universitario La Paz
Outcome results
None listed