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

November 24, 2021 updated by: Centre Hospitalier Universitaire Dijon

Prognosis After Revascularization Therapy in the Dijon Ischemic Stroke Evaluation Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

821

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ischemic stroke patients
Biological: prise de sang
Other: quality of life questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of handicap
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum levels of biomarkers of stress
Time Frame: Changes compared with baseline levels at Day 1, Day 3, Day 7
Changes compared with baseline levels at Day 1, Day 3, Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2016

Primary Completion (Actual)

June 11, 2019

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Actual)

November 26, 2021

Last Update Submitted That Met QC Criteria

November 24, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Béjot 2015-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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