Back to resultsFunctional Prognosis in Patients With Ischemic Stroke According to the Therapeutic Strategy Used (PARADISE)
Primary Purpose
Ischemic Stroke
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
prise de sang
quality of life questionnaire
Sponsored by
About this trial
This is an interventional prevention trial for Ischemic Stroke
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- CHU Dijon Bourgogne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ischemic stroke patients
Arm Description
Outcomes
Primary Outcome Measures
Rate of handicap
Secondary Outcome Measures
Serum levels of biomarkers of stress
Full Information
NCT ID
NCT02856074
First Posted
August 2, 2016
Last Updated
November 24, 2021
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT02856074
Brief Title
Functional Prognosis in Patients With Ischemic Stroke According to the Therapeutic Strategy Used
Acronym
PARADISE
Official Title
Prognosis After Revascularization Therapy in the Dijon Ischemic Stroke Evaluation Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 13, 2016 (Actual)
Primary Completion Date
June 11, 2019 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
821 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ischemic stroke patients
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
prise de sang
Intervention Type
Other
Intervention Name(s)
quality of life questionnaire
Primary Outcome Measure Information:
Title
Rate of handicap
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Serum levels of biomarkers of stress
Time Frame
Changes compared with baseline levels at Day 1, Day 3, Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
CHU Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21079
Country
France
12. IPD Sharing Statement
Learn more about this trial
Functional Prognosis in Patients With Ischemic Stroke According to the Therapeutic Strategy Used
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