Functional Prognosis in Patients With Ischemic Stroke According to the Therapeutic Strategy Used

Ischemic Stroke Clinical Trial

— PARADISE  

Official title:

Prognosis After Revascularization Therapy in the Dijon Ischemic Stroke Evaluation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856074
• Other study ID #: Béjot 2015-2
• Status: Completed
• Phase: N/A
• Start date: January 13, 2016
• Est. completion date: June 1, 2020

Study information

• Verified date: November 2021
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 821
• Est. completion date: June 1, 2020
• Est. primary completion date: June 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Biological:
• prise de sang

Other:
• quality of life questionnaire

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of handicap		6 months
Secondary	Serum levels of biomarkers of stress		Changes compared with baseline levels at Day 1, Day 3, Day 7