Clinical Trials Logo
  1. Home
  2. Ischemic Stroke
  3. NCT01812993

Reversal of the Neurological Deficit in Acute Stroke With the Signal of Efficacy Trial of Auto BPAP to Limit Damage From Suspected Sleep Apnea — Reverse-STEAL  

Ischemic Stroke Clinical Trial

Official title:
Reversal of the Neurological Deficit in Acute Stroke With the Signal of Efficacy Trial of Auto BPAP to Limit Damage From Suspected Sleep Apnea (Reverse-STEAL): A Multicenter Randomized Study

Clinical Trial Summary

Although the negative impact of sleep apnea on the clinical course of acute ischemic stroke (AIS) is well known, data regarding non-invasive ventilation in acute patients are scarce. Several studies showed its tolerability, safety and signals-of-efficacy, yet no controlled randomized sequential phase studies currently exist that aim to establish the efficacy of early non-invasive ventilation in AIS patients. The main hypothesis for this study is that early non-invasive ventilation with automated bilevel positive airway pressure (auto-BPAP) positively affects short-term clinical outcomes in AIS patients. This is a multicenter, prospective, randomized, controlled, third rater-blinded, parallel-group trial. Patients with AIS with proximal arterial obstruction and clinically suspected sleep apnea will be randomized to standard or standard stroke care plus auto-BPAP. Auto-BPAP will be initiated within 24 hours from stroke onset and performed for a maximum of 48 hours during diurnal and nocturnal sleep. Patients will undergo cardiorespiratory polygraphy between day 3 and 5 to assess sleep apnea. The primary endpoint is any early neurological improvement on the NIHSS at 72 hours from randomization. Safety, tolerability, short-term and 3 months functional outcomes are assessed as secondary endpoints by un-blinded and blinded observers respectively. This study will provide data to power a subsequent phase III study.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01812993
Study type Interventional
Source Technische Universität Dresden
Contact Jessica Kepplinger, MD
Phone +49-351-458-18515
Email jessica.kepplinger@uniklinikum-dresden.de
Status Recruiting
Phase Phase 2
Start date March 2013
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Recruiting NCT05518305 - Platelet Expression of FcγRIIa and Arterial Hemodynamics to Predict Recurrent Stroke in Intracranial Atherosclerosis
Recruiting NCT06029959 - Stroke and CPAP Outcome Study 3 N/A
Recruiting NCT03728738 - Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke Phase 3
Terminated NCT03396419 - IMPACT- 24col Collateral Blood Flow Assessment Following SPG Stimulation in Acute Ischemic Stroke (ImpACT-24B Sub-Study)
Recruiting NCT05065216 - Treatment of Acute Ischemic Stroke (ReMEDy2 Trial) Phase 2/Phase 3
Recruiting NCT04897334 - Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke N/A
Not yet recruiting NCT06462599 - Osteopontin Gene Polymorphism in Stroke Patients in Egypt
Not yet recruiting NCT06026696 - Cohort of Neurovascular Diseases Treated in the Acute Phase and Followed at Lariboisière
Not yet recruiting NCT06032819 - Differentiating Between Brain Hemorrhage and Contrast
Recruiting NCT02910180 - Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders
Completed NCT02922452 - A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects Phase 1
Completed NCT03554642 - Walkbot Robotic Training for Improvement in Gait Phase 3
Withdrawn NCT01866189 - Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke N/A
Recruiting NCT03041753 - Reperfusion Injury After Stroke Study N/A
Completed NCT02549846 - AdminiStration of Statin On Acute Ischemic stRoke patienT Trial Phase 4
Completed NCT02610803 - Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke N/A
Completed NCT01678534 - Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial Phase 2