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

• Sponsor: Centre Hospitalier Universitaire Dijon (Other)
• Overall Status: Completed
• CT.gov ID: NCT02856074
• Collaborator: (none)
• Enrollment: 821
• Location: 1
• Arm: 1
• Actual Duration (Months): 52.6
• Patients Per Site Per Month: 15.6

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke	Biological: prise de sang; Other: quality of life questionnaire	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 821 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Prognosis After Revascularization Therapy in the Dijon Ischemic Stroke Evaluation Study
• Actual Study Start Date: Jan 13, 2016
• Actual Primary Completion Date: Jun 11, 2019
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Rate of handicap [6 months]

Secondary Outcome Measures

1. Serum levels of biomarkers of stress [Changes compared with baseline levels at Day 1, Day 3, Day 7]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Dijon Bourgogne	Dijon		France	21079

Sponsors and Collaborators

• Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire Dijon
• ClinicalTrials.gov Identifier: NCT02856074
• Other Study ID Numbers: Béjot 2015-2
• First Posted: Aug 4, 2016
• Last Update Posted: Nov 26, 2021
• Last Verified: Nov 1, 2021

• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia

Study Results

No Results Posted as of Nov 26, 2021