NCT04001049

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 27, 2019

Completed
1 year until next milestone

Study Start

First participant enrolled

June 30, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

May 22, 2019

Last Update Submit

July 6, 2020

Conditions

Brain IschemiaHyperglycemiaGlycemic Variability

Outcome Measures

Primary Outcomes (2)

  • Glycemic variation impact in mortality of patients with acute ischemic stroke

    Intrahospital mortality

    3 months from stroke

  • 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 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

    3 months from stroke

Secondary Outcomes (2)

  • Impact of glycemic variation in mortality in diabetic patients with acute ischemic stroke.

    3 months from stroke

  • Impact of glycemic variation in functional status in diabetic patients with acute ischemic stroke.

    3 months from stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients \> 18 years old presenting with acute ischemic stroke of less than 24 hours of evolution

You may qualify if:

  • \> 18 years old
  • Functional independence prior to stroke
  • Signed informed consent

You may not qualify if:

  • Transient cerebral ischemia
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33148277DERIVED

Biospecimen

Retention: NONE RETAINED

Blood samples

MeSH Terms

Conditions

Brain IschemiaHyperglycemia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Blanca Fuentes Gimeno

    Hospital Universitario La Paz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Blanca Fuentes Gimeno

CONTACT

+34917277444blanca.fuentes@salud.madrid.org

Elena de Celis Ruiz

CONTACT

+34917277444elena.decelis.ruiz@idipaz.es

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2019

First Posted

June 27, 2019

Study Start

June 30, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

July 7, 2020

Record last verified: 2020-07

Locations

ES(1)