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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04001049
Other study ID # GLIAS-III
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 30, 2020
Est. completion date June 30, 2021

Study information

Verified date July 2020
Source Instituto de Investigación Hospital Universitario La Paz
Contact Blanca Fuentes Gimeno
Phone +34917277444
Email blanca.fuentes@salud.madrid.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 340
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Spain Hospital Universitario La Paz Madrid

Sponsors (1)

Lead Sponsor Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glycemic variation impact in mortality of patients with acute ischemic stroke Intrahospital mortality 3 months from stroke
Primary Glycemic variation impact in functional status of patients with acute ischemic stroke Modified Rankin Scale. This scale measures degree of disability/dependence after a stroke.
0- No symptoms
No significant disability despite symptoms; able to perform all usual duties and activities.
Slight disability; unable to perform all previous activities but able to look after own affairs without assistance.
Moderate disability; requires some help but able to walk without assistance.
Moderate severe disability; unable to walk without assistance an unable to attend to own bodily needs without assistance
Severe disability; bedridden, incontinent and requires constant nursing care and attention.
Death
3 months from stroke
Secondary Impact of glycemic variation in mortality in diabetic patients with acute ischemic stroke. Intrahospital mortality 3 months from stroke
Secondary Impact of glycemic variation in functional status in diabetic patients with acute ischemic stroke. Modified Rankin Scale. This scale measures degree of disability/dependence after a stroke.
0- No symptoms
No significant disability despite symptoms; able to perform all usual duties and activities.
Slight disability; unable to perform all previous activities but able to look after own affairs without assistance.
Moderate disability; requires some help but able to walk without assistance.
Moderate severe disability; unable to walk without assistance an unable to attend to own bodily needs without assistance
Severe disability; bedridden, incontinent and requires constant nursing care and attention.
Death
3 months from stroke
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