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Acute Stroke clinical trials

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NCT ID: NCT03443596 Completed - Blood Pressure Clinical Trials

Blood Pressure Control in Acute Ischemic Stroke

BP-Stroke
Start date: December 1, 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Management of acutely elevated blood pressure during the early phase of ischemic stroke remains controversial. In patients treated with IV-tPA, the risk of ICH is closely related to the BP levels. However, intensive reduction of BP carries a theoretical risk of clinical deterioration by inducing cerebral hypoperfusion. Assessment of cerebral perfusion before and after BP reduction is one of the most scientific method to evaluate the safety (and potential benefits) of BP management in the acute phase of stroke. This project will impact practices and delivery of BP management during the acute phase of ischemic stroke. The findings would aid in designing phase 3 clinical trials will track clinical indicators, including the impact on functional outcomes as well as quality-of-life and cost-effectiveness.

NCT ID: NCT03395717 Completed - Clinical trials for Cardiovascular Diseases

Stroke Rehabilitation With Exoskeleton-assisted Gait.

EKSOGAIT
Start date: March 16, 2016
Phase: N/A
Study type: Interventional

Gait recovery is one of the main goals of post-stroke rehabilitation where robotic-assisted practice has shown positive outcomes. However, literature lacks of clinical studies on exoskeleton-supported gait rehabilitation. Recently, a wearable exoskeleton (Ekso™, EksoBionics, USA) has been commercialized for re-enabling patients to stand and walk, involving them directly in steps trigger through body weight balance. The main aim of this study is to assess the clinical and neuromuscular effects of exoskeleton-based gait rehabilitation in sub-acute and chronic stroke patients, compared to patients with similar characteristics who will conduct a traditional over-ground gait training. In this multicentric RCT, 162 stroke patients will be enrolled and randomly assigned to the Experimental Group (EG) or to the Control Group (CG). Patients will conduct at least 12 one-hour-sessions (about 3 times/ week) of Ekso™ (EG) or traditional over-ground (CG) gait rehabilitation. Clinical evaluations (lower limb Modified Ashworth Scale- MAS; Motricity Index - MI; Trunk Control Test - TCT; Functional Ambulation Classification - FAC; 10-meter walking test - 10mwt; 6-minute walking test - 6mwt; Walking Handicap Scale - WHS; Time Up and Go - TUG) will be administered to patients at the beginning (T1) and at the end (T2) of the training period. The primary outcome is the distance performed during the 6mwt. A follow up study at 1 month (T3) and at 3 months (T4) after T2 will be conducted.

NCT ID: NCT03317639 Completed - Acute Stroke Clinical Trials

Improving In-hospital Stroke Service Utilisation in China

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

A cluster randomised controlled trial will be conducted, using hospital as randomisation unit. Hospitals in Zhejiang Province, China, will be randomised into two arms (1:1): an intervention arm and a control arm. Hospitals in the intervention arm will receive a multi-components intervention based on the Behaviour Change Wheel model, whereas hospitals in the control arm will receive no intervention and maintain existing care. The randomisation will be conducted after one-year baseline data collection. The following baseline data will be used for randomisation match: hospital classification, beds in stroke centre, thrombolysis patient number, and percentage of patients receiving thrombolysis within 60 minutes of stroke onset. Hospitals with no stroke centre or with <20 cases received thrombolysis per year will be excluded from the study. The primary outcome will be difference between intervention arm and control arm in the percentage of patients receiving thrombolysis within 60 minutes of stroke onset on the follow-up stage (post-intervention).

NCT ID: NCT03297827 Completed - Ischemic Stroke Clinical Trials

Cytokine Registry Database of Stroke Patients

CRISP
Start date: May 15, 2019
Phase:
Study type: Observational [Patient Registry]

Various molecules (cytokines: interleukins, interferons and neural proteins) found in human and animal blood are reported to be elevated in acute stroke (Ischemic and hemorrhagic). Cytokines can be pro-inflammatory or anti-inflammatory. There are studies confirming level changes in serum of humans in the setting of several rheumatologic and cardiovascular diseases. As new molecular markers (cytokines and neural tissue markers) are established in scientific literature, stroke scientists are interested to evaluate the role of these in the pathophysiology of stroke. Investigators intend to study the role of these molecules in the development of stroke. Acute stroke treatment has advanced considerably in the last 10 years with the establishment of comprehensive stroke centers and approval of neuro-interventional techniques. However, the molecular advancement in stroke pathogenesis has yet to reach a milestone in the world of stroke treatment. In our opinion, creating a database of acute stroke patients containing all pertinent medical demographics and clinical information along with the laboratory data, molecular levels of pertinent cytokines/neural factors from consenting patients, will help us define and delineate the most relevant molecules that are altered in acute stroke patients and can help us further improve us understanding of the role of these in acute stroke and thereby hopefully help in the improvement of our understanding and management of stroke. Moreover, analyzing the cytokines in stroke and ICH patients would help understand their role in the acute phase, which may become potential therapeutic adjuncts for tPA and endovascular thrombectomy.

NCT ID: NCT03284463 Completed - Acute Stroke Clinical Trials

Safety and Efficacy of Glibenclamide Combined With Rt-PA in Acute Cerebral Embolism

SE-GRACE
Start date: January 1, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This study is designed to evaluate the safety and efficacy of oral glibenclamide in acute ischemic stroke patients who under intravenous rt-PA thrombolysis.

NCT ID: NCT03281590 Completed - Stroke Clinical Trials

Stroke and Cerebrovascular Diseases Registry

Start date: September 6, 2017
Phase:
Study type: Observational [Patient Registry]

This is a single institutional registry database for the patients with stroke and cerebrovascular diseases. Stroke is the fifth leading cause of death in the United States. Despite extensive research, most of the patients die or suffer from varying degree of post-stroke disabilities due to neurologic deficits. This registry aims to understand the disease and examine the disease dynamics in the local community.

NCT ID: NCT03210051 Completed - Acute Stroke Clinical Trials

Remote Ischemic Conditioning Paired With Endovascular Treatment for Acute Ischemic Stroke (REVISE-1)

Start date: July 7, 2017
Phase: Phase 1
Study type: Interventional

Currently, early reperfusion is considered as the most effective therapy for the treatment of acute ischemic stroke (AIS). Over the past 20 years, intravenous tissue plasminogen activator (IV tPA) has been demonstrated to be the only effective therapy for AIS. More recently, several large randomized clinical trials have concluded the superiority of endovascular mechanical thrombectomy for AIS. Furthermore, with the development of materials and techniques, the occluded artery can be recanalized with high percentage (60%-90%), and the rate of recanalization is still being improved. A great number of AIS patients are now eligible for revascularization therapy and there should be a good prognosis of AIS after recanalizing the occluded artery using mechanical thrombectomy. However, things are never as simple as wished to be. The rate of patients with functional independence is less than 50% and over 15% patients died at 3 months post thrombectomy. The discrepancy between the functional outcome and recanalization rates encourage researchers to explore strategies that further improving the functional outcome of AIS patients. Remote ischemic conditioning has been demonstrated to reduce cerebral infarct size in mouse model of focal cerebral ischemia. And clinical researches demonstrated the protective effects of remote ischemic conditioning in AIS patient treated with IV tPA,. However, whether remote ischemic conditioning is safe and effective in protecting patients with large-vessel ischemic stroke and undergoing endovascular treatment is still unknown.

NCT ID: NCT03160677 Completed - Blood Pressure Clinical Trials

Blood Pressure Target in Acute Stroke to Reduce hemorrhaGe After Endovascular Therapy

BP-TARGET
Start date: June 21, 2017
Phase: N/A
Study type: Interventional

A randomized, multicenter study comparing two strategies: 1 / standard management of systolic blood pressure according to international recommendations (systolic blood pressure <185 mm Hg) versus 2 / intensive blood pressure management Systolic with a target <130 mm Hg.

NCT ID: NCT03048292 Completed - Acute Stroke Clinical Trials

New York City Mobile Interventional Stroke Team

NYC MIST
Start date: June 2016
Phase:
Study type: Observational

Endovascular treatment has recently become the recommended therapy for acute stroke after the publication of five randomized trials (MR CLEAN1, ESCAPE2, EXTEND IA3, SWIFT PRIME4, REVASCAT5) in 2015 that demonstrate its efficacy. Hospitals need to adapt to these updated stroke care guidelines, and many hospitals are not appropriately equipped for neurointerventional procedures. Decreased time to treatment is associated with favorable clinical outcomes, and best practices to optimize workflow between comprehensive stroke centers and secondary hospitals have become an important area of study. This prospective study is being conducted on acute stroke cases within the Mount Sinai Health System from 1 June 2016 up until 31 December 2018. The researchers would like to evaluate how variable methods of interventional service delivery for acute stroke affect clinical measures and outcomes. More specifically, the researchers are conducting this study in order to determine whether outcomes of neurointervention for large vessel occlusion in stroke, for patients presenting to and receiving treatment at a comprehensive stroke center, will be superior to that delivered by a mobilized intervention team at a central satellite hospital. In particular, the hypothesis is that factors affecting outcome include presentation to secondary hospital, delays with transfer including traffic conditions and time of day, and the acquisition of complex imaging within secondary hospitals.

NCT ID: NCT03036020 Completed - Clinical trials for Traumatic Brain Injury

The Norwegian Acute Stroke Prehospital Project

NASPP
Start date: October 2014
Phase: N/A
Study type: Interventional

The main aim of the NASPP study is to assess the efficacy and safety of the prehospital diagnosis of stroke using the Norwegian stroke ambulance concept. NASPP aims to demonstrate that anesthesiologists trained in pre-hospital critical care may perform acute stroke diagnostics by clinical assessment and CT scan interpretation and integrating these skills in the already existing organizational frame of the Norwegian prehospital EMS system. NASPP will systematically explore the Norwegian model of prehospital acute stroke diagnostics prior to the implementation of prehospital thrombolytic stroke treatment. NASSP will equip a regular ambulance staffed with a specially trained anesthesiologist and a specialized nurse. NASPP will perform the clinical part of the study in close co-operation with Østfold Hospital, Fredrikstad.