Ischemic Stroke Clinical Trial
Official title:
REperfusion With Cooling in CerebraL Acute IscheMia II
The purpose of this study is to determine whether reducing a patient's body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients who have suffered a significant interruption of blood flow to an area of brain (occlusion of large proximal cerebral artery) and have undergone successful removal of that interruption (revascularization).This will be achieved by comparing patients who have undergone hypothermia to those who have not.
This study is designed to examine the safety and proof of concept of therapeutic hypothermia
prior to conventional revascularization in subjects experiencing acute ischemic stroke by
comparing the results to subjects who remain at normal body temperature (normothermic) and
proceed directly to reperfusion via conventional reperfusion intervention.
The investigational plan also examines the following outcomes in 85 subjects randomized to
either hypothermia or normothermia:
- Regulation of biomarkers indicative of ischemia-reperfusion injury
- Changes in blood brain injury using the Hyperintense Acute Reperfusion Marker (HARM)
protocol MRI as a surrogate imaging biomarker
- Incidence of hemorrhagic conversion post reperfusion
- Neurologic function at 90 days post acute ischemic stroke.
The results of this study will be used to power a definitive phase III clinical trial
evaluating the combination of hypothermia and revascularization versus reperfusion alone.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| 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 |
NCT06032819 -
Differentiating Between Brain Hemorrhage and Contrast
|
||
| Not yet recruiting |
NCT06026696 -
Cohort of Neurovascular Diseases Treated in the Acute Phase and Followed at Lariboisière
|
||
| Recruiting |
NCT02910180 -
Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders
|
||
| 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 | |
| Completed |
NCT02922452 -
A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects
|
Phase 1 | |
| 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 |