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Ischemia clinical trials

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NCT ID: NCT06404229 Not yet recruiting - Clinical trials for Surgery-Complications

Use of CPETarm for Risk Stratification of Patients With CLTI

Start date: May 28, 2024
Phase: N/A
Study type: Interventional

This is a prospective cohort study of patients undergoing surgery for chronic limb threatening ischaemia. Prior to surgery, patients will undergo CardioPulmonary Exercise testing (CPET) using an arm ergometer. Feasibility outcome measures will be recorded at testing and participants will be followed up for a period of up to 5 years to obtain clinical outcome measures.

NCT ID: NCT06403267 Not yet recruiting - Clinical trials for Acute Ischemic Stroke

NoNO-42 Trial in Acute Ischemic Stroke Patients Selected for Thrombolysis With or Without Endovascular Thrombectomy

Start date: May 2024
Phase: Phase 2
Study type: Interventional

ACT-42 is a domain of the ACT-GLOBAL platform (NCT06352632). This trial is a Phase 2b, multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled single-dose adaptive trial. A total of up to 600 male and female participants aged ≥ 45 to ≤ 90 years harboring an acute ischemic stroke who are eligible for an intravenous thrombolytic with or without endovascular thrombectomy therapy will be enrolled within 3 hours of stroke onset/last known well.

NCT ID: NCT06400407 Not yet recruiting - Clinical trials for Stroke, Acute Ischemic

Lesion Network MApping Navigated Continuous Theta-burst STimulation for Motor REcovery in Acute Ischemic Stroke

MASTRE
Start date: May 6, 2024
Phase: Phase 2
Study type: Interventional

This is a multicenter, sham-controlled, double-blind, randomized clinical trial to evaluate the efficacy and safety of lesion network mapping navigated cTBS in improving motor function in patients with acute ischemic stroke at 3-14 days after onset.

NCT ID: NCT06396858 Not yet recruiting - Ischemic Stroke Clinical Trials

Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke

ARCHIMEDES
Start date: July 2024
Phase: Phase 4
Study type: Interventional

The ARCHIMEDES study (Anti-inflammatory and anti-thRombotic therapy with colCHicine and low dose rIvaroxaban for Major adverse cardiovascular Events reDuction in ischEmic Stroke) will be a randomized, double-blind, 2x2 factorial clinical trial, which will include at least 3000 and up to a maximum of 4500 patients with ischemic stroke without indication of oral anticoagulation.

NCT ID: NCT06394180 Not yet recruiting - Clinical trials for Acute Ischemic Stroke

PeRforation EVents During ENdovascular Therapy for Acute Ischemic Stroke

PREVENT
Start date: June 2024
Phase:
Study type: Observational [Patient Registry]

A large, worldwide study called PREVENT is looking at a complication that can happen during a stroke treatment called thrombectomy. This complication is a perforation of a blood vessel. The investigators aim to: 1. Find what factors make this perforation more likely. 2. Understand why the perforation happens by looking closely at images taken during the procedure. 3. Create a simple way to classify these perforations to help doctors decide how to treat them right away. 4. Improve the emergent treatment of vessel perforation to stop the bleeding rapidly. 5. Provide data to guide decision whether thrombectomy should be continued or aborted after the event of vessel perforation. 6. Develop a safer way to perform thrombectomy. Investigators will compare the results collected for patients where perforation happened with those where perforation did not happen.

NCT ID: NCT06388148 Not yet recruiting - Clinical trials for Stroke, Acute Ischemic

Endovascular Treatment for eXtra-Large Ischemic Stroke

XL STROKE-2
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The role of endovascular thrombectomy in patients with extra-large ischemic burden is still unclear. The XL STROKE-2 randomized trial is aiming to investigate the efficacy and safety of mechanical thrombectomy in acute extra-large ischemic stroke patients with large vessel occlusion.

NCT ID: NCT06387147 Not yet recruiting - Clinical trials for Acute Mesenteric Ischemia

ORal Antibiotics In Acute Mesenteric Ischemia

ORIAMI
Start date: September 1, 2024
Phase: Phase 3
Study type: Interventional

Acute mesenteric ischemia (AMI) is a life-threatening condition with an increasing incidence (7-13/100000 PY). The mortality of AMI is associated with the development and extent of transmural intestinal necrosis (IN), ranging from 25% without IN to 75% with IN. Given its potential reversibility, preventing the progression of AMI towards IN is now considered a primary therapeutic goal. Early management of AMI can thus avoid fatal outcomes and prevent lifelong complications such as short bowel syndrome. Following the results of a pilot study showing an improvement in survival and lower resection rates, our team created a first-of-its-kind intestinal stroke center (SURVI unit, Beaujon Hospital, Clichy, France) that provides 24/7 standardized multimodal and multidisciplinary care to AMI patients referred from all hospitals in the Paris region. As no randomized clinical trial has ever been conducted, the treatment offered by SURVI is based on pathophysiological knowledge and observational clinical data. AMI naturally progresses to sepsis, surgical complications, and multi-organ failure, direct consequences of IN. Features of sepsis are reported in up to 90% of AMI patients compared with 3-22% of patients with brain or myocardial ischemia, supporting a specific septic component in AMI. Experimental studies demonstrated reduced translocation and mortality in germ-free animals or after administration of oral antibiotics targeting Gram-negative and anaerobic early bacterial overgrowth and translocation. In a prospective observational study, the investigators recently suggested a protective effect of systematic oral antibiotics in terms of intestinal preservation, yielding a reduced occurrence of IN (HR: 0.16, 95% confidence interval 0.03-0.62). However, the systematic use of oral antibiotics in AMI remains controversial due to the individual and collective risk of increasing the carriage of multi-drug resistant bacterias.

NCT ID: NCT06386874 Not yet recruiting - Ischemic Stroke Clinical Trials

EMAGINE 2.0 - Electromagnetic Field Ischemic Stroke - Novel Subacute Treatment

Start date: July 2024
Phase: N/A
Study type: Interventional

This is a multicenter study that will be conducted at approximately 15 centers. BQ 3.0 is a wearable medical device that produces and delivers non-invasive, extremely-low-intensity and low-frequency, frequency-tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery. The BQ 3.0 system is indicated for adjunctive use in a clinical facility or home setting, in addition to standard-of-care therapies. Up to 45 sessions between days 4 and 90 (±15) after the onset of the index stroke, with up to 5 treatments per week. Each session will last approximately 60 minutes, with stimulation activated for up to 40 minutes, in conjunction with a home-based exercise program. The study will enroll up to 150 adult subjects who will be randomly assigned (1:1 allocation ratio) to either active or sham study intervention using BQ 3.0 system

NCT ID: NCT06386289 Not yet recruiting - Clinical trials for Acute Ischemic Stroke

Safety, Performance of CEREGLIDE 92 Intermediate Catheter in Treatment of Acute Ischemic Stroke

SPLENDID
Start date: September 1, 2024
Phase: N/A
Study type: Interventional

The device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease

NCT ID: NCT06381089 Not yet recruiting - Ischemic Stroke Clinical Trials

Effect Of Robotic Rehabilitation And Vagus Nerve Stimulation In Ischemia Stroke Patients

ERRVNS
Start date: May 10, 2024
Phase: N/A
Study type: Interventional

This study was conducted in patients with ischemic stroke; This study was conducted to examine the effect of robotic rehabilitation and transcutaneous auricular vagal nerve stimulation applied in addition to robotic rehabilitation on the patient's functional level and autonomic nervous system. 40 people over the age of 18 participated in the study. They were randomly divided into two groups: robotic rehabilitation and transcutaneous auricular vagal nerve stimulation applied in addition to robotic rehabilitation. While the robotic rehabilitation group received Lokomat and neurological rehabilitation, the other group received stimulation with the Vagustim device, which is applied non-invasively through the ear, in addition to Lokomat and neurological rehabilitation. Spasticity, autonomic nervous system, walking speed, motor function, quality of life, muscle activity and pain were evaluated in both groups before starting treatment and six weeks after treatment. In the study, significance was evaluated at p<0.05 level.