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Ischemia clinical trials

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NCT ID: NCT04054609 Recruiting - Clinical trials for Critical Limb Ischemia

FAZA PET/MRI in CLI Patients Pre and Post Revascularization

Start date: August 31, 2019
Phase: N/A
Study type: Interventional

Peripheral artery disease is a worldwide problem, leading to high mortality and mobility. Critical limb ischemia (CLI) is associated with high risk of amputation with the subsequent decreased in life quality. Endovascular therapy is now considered the primary treatment option in these patients to improve the vascularity and prevent amputations. In recent years, development of molecular imaging tools are now become available. A recent radio tracer named 18F-Fluoroazomycin Arabinoside (FAZA) its an specific marker of hypoxia in the tissues and has been used in multiples studies. This tracer can be used in PET/MR scan providing a potentially power diagnostic tool in patients with CLI, allowing in one diagnostic study the evaluation of location and degree of hypoxia in the extremity tissues. This diagnostic tool may offer a better assessment pre and post standard of care endovascular treatment for the patients. Moreover, some of the patients treated with endovascular therapy may not have a favorable outcome, without a clear reason explaining this situation. We will try to find some predictor model in the FAZA PET/MR that can explain the different outcomes and may help clinicians choose the best treatment option in specific cases. Thirdly, post processing for optimization of the MR sequences in patients with CLI will be performed at the MR component of the PET. There would thus be great clinical interest in developing non-invasive tools that could provide more accurate diagnostic information compared to traditional tests for these patients population.

NCT ID: NCT04050501 Recruiting - Ischemic Stroke Clinical Trials

Non-invasive Vagus Nerve Stimulation in Acute Ischemic Stroke

NOVIS
Start date: October 9, 2019
Phase: N/A
Study type: Interventional

The main objective of the study will be to investigate whether treatment with non-invasive vagus nerve stimulation (nVNS) on top of best medical practice in acute ischemic stroke patients results in less infarct growth in the penumbra and smaller infarct volumes compared with those of patients not treated with nVNS. The study will be a prospective randomized clinical trial with blinded outcome assessment (PROBE design). 150 patients will be randomized to nVNS with the gammaCore Sapphireâ„¢ device on top of best medical practice versus best medical practice alone (including intravenous thrombolysis and/or thrombectomy if indicated). If patients are randomized to nVNS, two stimulations of two minutes each will be applied in the neck every 15 minutes in the first 3 hours. Thereafter two stimulations will be applied every 8 hours over the next 5 days or until discharge, whichever occurs first. The stimulation side in the neck will be the radiological side of the stroke. The primary endpoint will be the final infarct volume on MRI scan on day 5 of patients treated with nVNS compared with those of patients not treated with VNS.

NCT ID: NCT04038697 Recruiting - Stroke Clinical Trials

Ischemic Conditioning Improves Walking Function Post Stroke

Start date: December 20, 2018
Phase: N/A
Study type: Interventional

This innovative study will address scientific and clinical areas relatively unexplored in chronic stroke that could lead to greater recovery of walking. Ischemic Conditioning (IC) is a non-invasive, simple procedure that improves motor function, exercise performance and cardiovascular function in healthy controls, but it has never been applied to the stroke population. We postulate that IC enhances the recruitment of motoneurons and results in positive neural adaptations, improves vascular endothelial function and peripheral blood flow, and together these improvements result in an increased capacity to exercise and faster walking speed. Future studies will examine the effects of IC and traditional therapy at different time points of recovery post stroke, durability of IC, molecular mechanisms of neural and cardiovascular adaptation and the efficacy compared with other adjuncts.

NCT ID: NCT04038125 Recruiting - Clinical trials for Diabetic Retinopathy

Increase in Capillary Plexus Density Level Following the Use of Ozurdex for the Treatment of DME

ICOD
Start date: August 22, 2019
Phase: Phase 4
Study type: Interventional

The objective of this study is to test the hypothesis that following the use of intravitreal dexamethasone implant for the treatment of DME, there will be an observable increase in the capillary density plexus as denoted by the quantitative assessment of the superficial capillary plexus on OCTA, as well as a decrease in size of the foveal avascular zone (FAZ).

NCT ID: NCT04035746 Recruiting - Stroke, Ischemic Clinical Trials

Microcirculation and Plasticity After Stroke

IMPreST
Start date: October 7, 2019
Phase:
Study type: Observational

Reperfusion is the main goal of early medical interventions after stroke, such as thrombolysis and thrombectomy. Recanalization works only if applied early - the earlier the better, but with a statistical cutoff of 4.5 hours where risk of hemorrhage outweighs the benefit. Recently, this cutoff has been put into perspective using standardized perfusion measurements by magnetic resonance imaging (MRI) or computed tomography (CT). Two trials have shown that revascularization is beneficial up to 24 hours after stroke onset if patient selection is based on perfusion imaging. This suggests interindividual differences in the temporal evolution of an infarction. One explanation for interindividual differences is the variability of the collateral blood supply to the brain, which in turn can maintain different perfusion pressures around the infarct core, also called the penumbra region. Insufficient recruitment of these collateral pathways is an independent negative predictor of poor outcome; the insufficiency may in part be explained by insufficient dilatation of arterioles ("low dilator reserve"). So far, interventions to improve collateral perfusion, e.g., induced hypertension, have not demonstrated effectiveness, likely because our understanding of collateral perfusion, demand-dependent dilatation of arteries (cerebrovascular reserve, CVR) and their effect on microcirculation is insufficient. Functional recovery after a brain lesion is based on plasticity. Plasticity involves the creation of new synapses, fibers (axons and dendrites) and lasting modification to synaptic strength as well as the formation and migration of new neurons. In the cortex surrounding an infarct, plasticity is facilitated by ischemia via modification of gene expression, i.e. a certain time window after stroke, and is stimulated by activity and training. Tissue microcirculatory status and perfusion surrounding the stroke lesion may play a role in the formation of this plasticity. The investigators will analyze the contributions of pre-existing vascular networks, the impact of stroke-affected vessels, timing and degree of recanalization success, brain excitability, and short-term intra-cortical inhibition to better understand how these factors relate to functional recovery after stroke.

NCT ID: NCT04027244 Recruiting - Clinical trials for Coronary Artery Disease

Leg Ischaemia Management Collaboration

LIMb
Start date: May 10, 2019
Phase:
Study type: Observational

Single-centre prospective cohort study of patients presenting with severe limb ischaemia (SLI). The primary outcome measure will be 12 month major amputation rate. A historical cohort of patients identified retrospectively will be the comparitor group used to assess the impact of a newly-established rapid-access limb salvage clinic. Primary aim: - Determine the proportion of patients with SLI undergoing major lower limb amputation within 12 months of presentation. Secondary aims: - Assess clinically important short-, medium- and long-term outcomes in those undergoing and not undergoing amputation - Prevalence and degree of frailty and cognitive impairment - Pevalence and degree of cardiac disease (detected by stress MRI) - Establish a biobank for future biomarker analysis - Investigate the role of frailty and cognitive assessments, cardiac MRI and biomarkers in risk-stratification of patients with SLI

NCT ID: NCT04014621 Recruiting - Ischemic Stroke Clinical Trials

Augmenting Cerebral Blood Flow to Preserve the Penumbra Trial

ImpACT-P
Start date: October 20, 2019
Phase: N/A
Study type: Interventional

The primary objective of the study is to demonstrate that SPG (Sphenopalatine Ganglion) stimulation started within 6 hours from stroke onset slows the expansion of the infarct core volume in acute ischemic stroke.

NCT ID: NCT04010955 Recruiting - Atrial Fibrillation Clinical Trials

Adding Antiplatelet During Edoxaban Treatment in Stroke Patients With Non-valvular Atrial Fibrillation (ADD-ON)

(ADD-ON)
Start date: October 1, 2019
Phase:
Study type: Observational [Patient Registry]

This study aims to compare the effectiveness and safety regarding treatment with standard anticoagulant only or adding antiplatelet to anticoagulant in patients with non-valvular atrial fibrillation and significant atherosclerosis including extracranial, intracranial, coronary or peripheral artery.

NCT ID: NCT04005469 Recruiting - Clinical trials for Delayed Graft Function

Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation

Start date: November 13, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The objectives of this study are to test the preliminary safety and efficacy of a two-day peri-operative course of treprostinil in reducing ischemia-reperfusion injury in adult patients receiving a deceased donor kidney transplantation. Treprostinil, a prostacyclin analog, is expected to facilitate the restoration of blood supply to the revascularized kidney graft via its vasodilatory actions, well characterized protective effects, and longer elimination half-life. These properties and actions of treprostinil make it a strong drug candidate to reduce kidney graft dysfunction during kidney transplantation. An anticipated 20 participants undergoing deceased donor kidney transplant will be hospitalized and intensively monitored during an entire two-day Treatment Phase. An IV infusion using a dedicated central venous line will be used to administer treprostinil commencing approximately 2-3 hours before transplantation of the kidney graft and will continue for approximately 48 hours after completion of the transplant surgery. The primary endpoints include the safety and efficacy of treprostinil, with secondary endpoints including the evaluation of both biochemical and clinical endpoints post-transplantation.

NCT ID: NCT04001049 Recruiting - Hyperglycemia Clinical Trials

Glycemic Variability: Prognostic Impact on Acute Ischemic Stroke

GLIAS-III
Start date: June 30, 2020
Phase:
Study type: Observational

This is a multicenter observational clinical study in patients with acute ischemic stroke. The main objective is to evaluate the impact of glycemic variability (GV) on stroke outcome (mortality, functional recovery) of patients with acute ischemic stroke. Glycemic variability will be assessed using a subcutaneous device for continuous glycaemia motorization during 96 hours; also capillar glycaemia will be measured every 6 hours.