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Ischemia clinical trials

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NCT ID: NCT04005989 Withdrawn - Clinical trials for Coronary Artery Disease

Adipose Stromal Cells Injection in the Myocardium for Induction of Revascularization

ADMIRE
Start date: December 1, 2021
Phase: Phase 3
Study type: Interventional

Treatment of ischemic myocardium has been the subject of intense research in recent years and stem cell therapy is one of the great promises. The InCor laboratory has studied cells from different backgrounds as candidates for cell therapy in the context of myocardial infarction. Evidence in preclinical studies of the application of stromal (mesenchymal) adipose tissue (hASC) in the ischemic heart by both the InCor group (in the animal model in rodents and pigs) and others in the literature suggest relevant benefits on the decrease of deterioration post-infarction. More recently it has been demonstrated that it arises mainly from the formation of new vessels due to paracrine factors, which are secreted by the injected cells. There are currently no studies in Brazil in which the safety of injecting different doses of hASC cells into the heart has been particularly evaluated. Recently, two studies have demonstrated the clinical applicability of hASC in patients with peripheral ischemic disease and stroke. Thus, the objective of this work will be to test the hypothesis that the implantation of autologous stromal cells derived from adipose tissue combined with myocardial revascularization surgery in patients with coronary artery disease

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: NCT04005222 Completed - Clinical trials for Anterior Segment Ischemia (Diagnosis)

Effects of Selenium and Melatonin on Ocular Ischemic Syndrome

Start date: May 2014
Phase: Early Phase 1
Study type: Interventional

ABSTRACT: PURPOSE: To determine the effects of selenium, melatonin and selenium + melatonin administered for one month on anterior chamber (AC ) malondialdehyde (MDA) and AC glutathione (GSH) levels in patients with Ocular ischemic syndrome. MATERIAL AND METHODS: Thirtyfive patients were included in the study. Study groups were formed as follows: 1-Control group, 2-Ischemia group 3-Selenium Ischemia group, 4-Melatonin Ischemia group, 5-Selenium + Melatonin + Ischemia group. AC samples were obtained. MDA and GSH levels in AC samples were evaluated. RESULTS : MDA levels were significantly increased in ischemia groups. Selenium and melatonin supplementation resulted in reduction of MDA levels and significant increase in GSH values. DISCUSSION: Increased lipid peroxidation associated with ischemia of the anterior segment has been prevented by selenium and melatonin supplementation. KEYWORDS: Ocular ischemic syndrome, selenium, melatonin, MDA, GSH

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.

NCT ID: NCT04000334 Recruiting - Cardiac Arrest Clinical Trials

Early Transcranial Doppler Goal Directed Therapy After Cardiac Arrest: a Pilot Study

GOODYEAR
Start date: July 29, 2020
Phase: N/A
Study type: Interventional

Hypoxic-ischaemic brain injury (HIBI) is the main cause of death in patients who are comatose after resuscitation from cardiac arrest. Current guidelines recommend to target a mean arterial pressure (MAP) above 65 mmHg to achieve an adequate organ perfusion. Moreover, after cardiac arrest, cerebral autoregulation is dysregulated and cerebral blood flow (CBF) depends on the MAP. A higher blood pressure target could improve cerebral perfusion and HIBI. Transcranial Doppler (TCD) is a non-invasive method to study CBF and its variations induced by MAP. The aim of this study is to test the feasibility of an early-goal directed hemodynamic management with TCD during the first 12 hours after return of spontaneous circulation (ROSC).

NCT ID: NCT03998631 Recruiting - Clinical trials for Thoracic Aortic Aneurysm

Comparison of Carbon Dioxide and Saline Flush to Saline Flush in TEVAR and TAVI Procedures to Reduce Cerebral Ischemia

Start date: July 20, 2019
Phase: Phase 1
Study type: Interventional

Thoracic endovascular repair (TEVAR) and transcatheter aortic valve implantation (TAVI) are standard of care procedures to treat thoracic aortic aneurysm or severe aortic stenosis, respectively. Both procedures have a high risk of stroke and silent infarction. Gas has been detected in the cerebral vasculature during these procedures and associated with DWI positive lesions on MRI. The hypothesis is that air emboli contribute to stroke and silent infarction. The investigators propose addressing air emboli by flushing the device with carbon dioxide prior to flushing with saline. This is a pilot study comparing standard saline flush alone to carbon dioxide flushing with saline flush.

NCT ID: NCT03997292 Withdrawn - Ischemic Stroke Clinical Trials

Intravenous Thrombolysis Registry for Acute Ischemic Stroke in China

Start date: March 1, 2018
Phase:
Study type: Observational

To analyze the real situation of intravenous thrombolysis in acute ischemic stroke in China

NCT ID: NCT03997201 Completed - Clinical trials for Ischemic Heart Disease

Ripple Mapping Guided Ablation of Ischaemic Ventricular Tachycardia.

RIPPLE-VT
Start date: April 18, 2019
Phase: N/A
Study type: Interventional

The Ripple VT-1 Study is a prospective clinical trial that aims to investigate if catheter ablation of ventricular tachycardia in patients with ischaemic heart disease can be effectively performed using Ripple Mapping.

NCT ID: NCT03994822 Completed - Clinical trials for Cardiovascular Diseases

pRESET for Occlusive Stroke Treatment

PROST
Start date: October 4, 2019
Phase: N/A
Study type: Interventional

Compare the safety and effectiveness of pRESET to Solitaire in the treatment of stroke related to large vessel occlusion

NCT ID: NCT03994666 Not yet recruiting - Clinical trials for Critical Limb Ischemia

Cell Therapy in Critical Limb Ischemia

CLI
Start date: September 2019
Phase: Phase 2
Study type: Interventional

Study drug and dosage form : Umbilical cord-derived mesenchymal stem cells (HB-MSC1) Dose and route of administration : 60 × 106 cells or 120 x 106 cells to be injected as 30 individual intramuscular injections, once at V0 within 48 hours to 2 weeks maximum after the revascularization procedure. Comparator, dose and route of administration : Placebo, injected as 30 individual intramuscular injections, once at V2 within 48 hours to 2 weeks maximum after the revascularization procedure. Study centers : 3 centers in France Study objectives : Primary: Evaluation of the feasibility and systemic and local tolerance of an implantation, via intramuscular route, of allogenic HB-MSC1, associated with a revascularization procedure, in patients suffering from critical limb ischemia (CLI). Secondary: Preliminary evaluation of efficacy and dose effect relationship of the MSC implantation in hemodynamic, anatomical and functional terms. Exploratory: Constitution of a serum bank of the patients included in the study for inflammation and auto immunity biomarkers analysis Study design : This will be a multicenter Phase IIa study, consisting in a first, open-label, ascending dose feasibility and safety stage followed by a randomized placebo-controlled feasibility, safety and preliminary efficacy stage.