Glycemic Variability: Prognostic Impact on Acute Ischemic Stroke

• Conditions: Brain Ischemia; Glycemic Variability; Hyperglycemia

• Registration Number: NCT04001049
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

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.

Study Timeline

• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-27
• Study Start: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-06
• Last Update Posted: 2020-07-07
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

• > 18 years old
• Inclusion less than 24 hours from ischemic stroke
• Functional independence prior to stroke
• Signed informed consent

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Impact of glycemic variation in mortality in diabetic patients with acute ischemic stroke.	3 months from stroke	Intrahospital mortality

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain