Clinical trial NCT04001049: Glycemic Variability: Prognostic Impact on Acute Ischemic Stroke
Official title: Glycemic Variability: Prognostic Impact on Acute Ischemic Stroke and Impact of the Corrective Treatment for Hyperglycemia.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Ischemia
Hyperglycemia
Glycemic Variability
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \> 18 years old presenting with acute ischemic stroke of less than 24 hours of evolution

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycemic variation impact in mortality of patients with acute ischemic stroke
timeFrame: 3 months from stroke
measure: Glycemic variation impact in functional status of patients with acute ischemic stroke
timeFrame: 3 months from stroke
Secondary outcomes:
measure: Impact of glycemic variation in mortality in diabetic patients with acute ischemic stroke.
timeFrame: 3 months from stroke
measure: Impact of glycemic variation in functional status in diabetic patients with acute ischemic stroke.
timeFrame: 3 months from stroke
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Hospital Universitario La Paz
name: Blanca Fuentes Gimeno
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fuentes B, Pastor-Yborra S, Gutierrez-Zuniga R, Gonzalez-Perez de Villar N, de Celis E, Rodriguez-Pardo J, Gomez-de Frutos MC, Laso-Garcia F, Gutierrez-Fernandez M, Ortega-Casarrubios M, Soto A, Lopez-Fernandez M, Santamaria M, Diez-Gonzalez N, Freijo MM, Zandio B, Delgado-Mederos R, Calleja A, Portilla-Cuenca JC, Lisbona A, Otero-Ortega L, Diez-Tejedor E. Glycemic variability: prognostic impact on acute ischemic stroke and the impact of corrective treatment for hyperglycemia. The GLIAS-III translational study. J Transl Med. 2020 Nov 4;18(1):414. doi: 10.1186/s12967-020-02586-4.