NCT02856074

Brief Summary

The current management of ischemic stroke is based on different strategies that may be combined: intravenous thrombolysis in a stroke ICU, intravenous thrombolysis in a telemedicine procedure, endovascular thrombectomy. Given this now rich therapeutic arsenal, it seems necessary to evaluate practices in local care in the field and the impact of these on the prognosis of ischemic stroke victims. The aim of this observational study is to compare these different care practices without interfering with the choice of strategy. A blood sample will also be taken at different times to study the value of growth differentiation factors (GDF) 8, 11 and 15, and Brain-derived Neurotrophic Factor as prognostic biomarkers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
821

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 13, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

3.4 years

First QC Date

August 2, 2016

Last Update Submit

November 24, 2021

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • Rate of handicap

    6 months

Secondary Outcomes (1)

  • Serum levels of biomarkers of stress

    Changes compared with baseline levels at Day 1, Day 3, Day 7

Study Arms (1)

Ischemic stroke patients

EXPERIMENTAL
Biological: prise de sangOther: quality of life questionnaire

Interventions

prise de sangBIOLOGICAL
Ischemic stroke patients
quality of life questionnaireOTHER
Ischemic stroke patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with symptomatic ischemic stroke defined according to WHO criteria and treated by intravenous thrombolysis at the stroke ICU at Dijon CHU, intravenous thrombolysis by telemedicine with subsequent transfer to the Dijon stroke ICU, and/or endovascular thrombectomy at Dijon CHU)
  • Patients aged over 18 years.
  • Patients who have provided written informed consent to take part in the study.

You may not qualify if:

  • Patients who refuse to take part in the study.
  • Subjects in custody.
  • Patients (or a person of trust) who cannot be contacted by telephone during the follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 4, 2016

Study Start

January 13, 2016

Primary Completion

June 11, 2019

Study Completion

June 1, 2020

Last Updated

November 26, 2021

Record last verified: 2021-11

Locations

FR(1)