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Ischemia clinical trials

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NCT ID: NCT02151877 Completed - Clinical trials for Ischemia/Reperfusion Injury After Neonatal Cardiac Surgery

Efficacy of Nitric Oxide Administration in Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass

Start date: July 2014
Phase: N/A
Study type: Interventional

Around 7500 neonates born yearly in the United States have complex congenital heart disease that require surgical repair in the first few days of life. The complexity of the surgical repair requires long periods of cardiopulmonary bypass (CPB) and the use of intermittent periods of low flow or complete circulatory arrest. The immature neonatal vital organs are more prone to the complications of the cardiopulmonary bypass circulation, namely ischemia/reperfusion (I/R) injury and systemic inflammatory response. Inhaled nitric oxide (NO) is used frequently in neonates for the treatment of pulmonary hypertension, Additionally, many studies have shown that NO has an anti-inflammatory effect by reducing I/R injury and endothelial dysfunction. The purpose of this pilot study is to assess the efficacy of NO administration via the CPB circuit in attenuating the CPB induced I/R injury and systemic inflammatory reaction in neonates undergoing repair of complex congenital heart defects. Specific goals will be to demonstrate that NO use via CPB will: - Decrease markers of I/R injury and systemic inflammatory response. - Decrease platelet activation leading to reduced postoperative bleeding and transfusion requirements. - Decrease postoperative organ dysfunction, and hence decrease operative mortality and postoperative morbidity. Twelve neonates undergoing repair of complex congenital heart defects will receive NO via the CPB circuit, for the duration of surgery. They will be compared to a control group of 12 similar patients. Serum levels of different ischemic reperfusion injury and inflammatory markers will be measured at different time points after surgery and will be correlated with different end organ function tests and clinical course in the postoperative period. The results will be compared between the two groups to try to determine the clinical benefit of NO administration through CPB circuit.

NCT ID: NCT02150252 Recruiting - Ischemic Stroke Clinical Trials

Evaluate the Efficacy of Bu-Yang- Huan-Wu Tang(BYHWT)on Ischemic Stroke

Start date: May 2014
Phase: Phase 2
Study type: Interventional

- Clinical trial; Ischemic stroke; Bu-Yang-Huan-Wu Tang (BYHWT); Gait parameter; Quality of life Stroke is the third of ten causing death disease constantly, and it also is third of consuming healthy insurance budget. There is 17,000 peoples disable due to stroke every year in Taiwan. Although ischemic stroke patient may use t-PA intravenously treatment within 3 hrs after stroke onset in modern medicine, and no others method may effect to treat ischemic stroke patients, thus, the study about stroke is an important issue. Bu-Yang- Huan-Wu Tang (BYHWT) has been became a main stream for the treatment of stroke after Qing dynasty Wang Qing-Ren theory that is BYHWT may treat stroke due to pattern of qi stagnation and blood stasis in traditional Chinese medicine. A number of researches report that BYHWT can reduce blood viscosity, anti-inflammation, enhancing neuronal regeneration and angiogenesis, but above-mentioned about BYHWT limit in the level of animal study and the scientific evidence is insufficiency in human trial. Therefore, the purpose of the present study was to investigate the therapeutic effect of BYHWT treating ischemic stroke by using a strict clinical trial. - We designed a randomized, double blind, placebo-controlled study to assess the therapeutic effect of BYHWT treating ischemic stroke. The study expects to finish the assessment of 120 patients with ischemic stroke in three years. The study divided into: 1) control group, receive placebo-BYHWT 3.0 g TID every day for continuously 6 weeks except ordinary medical care; 2) treatment group, the method is identical control group, but receive BYHWY. The main outcome was according to the changes of gait parameter including Speed, Cadence, Strike length, Gait cycle and Double support; and secondary outcome including the changes of Functional independence measurement scores and Barthel index scores, Ten Meters Walk Test, Short Physical Performance Batter, Berg Balance Test and WHO quality of life-brief (Taiwan Brief). - We predict the results of the present can provide scientific evidence to proof BYHWT can improve neurological deficit and also can improve quality of life in patients with ischemic stroke.

NCT ID: NCT02149316 Completed - Heart Failure Clinical Trials

Remote Ischemic Preconditioning With Postconditioning in Heart Transplantation Surgery

Start date: February 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether remote ischemic preconditioning with postconditioning (RIPC+RIPostC) reduces myocardial injury and improves clinical outcomes in heart transplantation surgery.

NCT ID: NCT02145897 Recruiting - Clinical trials for Critical Limb Ischemia

To Evaluate the Safety and Efficacy of IM and IV Administration of Autologous ADMSCs for Treatment of CLI

Start date: August 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Various preclinical animal studies have shown the potential of stem cells in re-vascularising ischemic limbs and promoting collateral vessel formation. SVF have the potential to facilitate the formation of new blood vessels and skeletal muscle. Early pilot clinical studies indicate that stem-cell transplantation is feasible and may have beneficial effects in CLI. Injury or inflammation is a prerequisite for the participation of circulating stem cells to home and differentiate on to this microenvironment. The increased vascular permeability and expression of adhesion proteins like integrin assist in stem cell homing. The migratory capacity of stem cells is dependent on natural growth factors such as vascular endothelial growth factor (VEGF), Stromal cell derived factor (SDFI) and stem cell factor (SCF). The expression of VEGF, SDFI and SCF is highly unregulated in the hypoxic muscular tissue and is responsible for the recruitment of the stem cells to assist in the repair mechanism and consequent improvement in limb function. In addition to the above regenerating potential of SVF, they have several advantages; they can be easily isolated without further culturing it. Most importantly SVF have shown to have significantly highest expression of pluripotent markers similar to that of human embryonic stem cells and yet they are non-tumorogenic and safe. MSCs are having angiogenic activity and hence may be excellent source to develop neo-vasculature and hence could be explored for their therapeutic potential for treating Critical Limb Ischemia. MSC's also display membrane-bound and insoluble secreted molecules involved with cell attachment to neighbouring cells and to the extra cellular matrix19 Adipose derived Stromal vascular fraction and Mesenchymal Stem Cells has been found in preclinical studies to be safe and effective. The current Phase I/II study of adipose derived stromal vascular fraction and Mesenchymal stem cells is conducted with the broad objective of establishing safety and efficacy.

NCT ID: NCT02145845 Completed - Clinical trials for Peripheral Arterial Disease

Pilot Safety Study of Injectable SIS for Critical Limb Ischemia

CLIC
Start date: April 2014
Phase: N/A
Study type: Interventional

This study is intended to collect safety and effectiveness data on the Cook Injectable Small Intestinal Submucosa (SIS)

NCT ID: NCT02144831 Withdrawn - Clinical trials for Transient Ischemic Attacks

The Middle East Dual Anti-platelet Treatment in Acute Transient Ischemic Attack

MENA-TIA
Start date: July 2014
Phase: Phase 4
Study type: Interventional

The primary goal of the research is to determine if 10 days of dual anti-platelet treatment is as effective as 30 days of similar treatment in the prevention of stroke, myocardial ischemia (MI) and death in patients with TIAs and minor stroke.

NCT ID: NCT02144610 Terminated - Clinical trials for Critical Limb Ischemia

Efficacy and Safety of AMG0001 in Subjects With Critical Limb Ischemia

AGILITY
Start date: November 12, 2014
Phase: Phase 3
Study type: Interventional

Study to Evaluate the Efficacy and Safety of AMG0001 in Subjects with Critical Limb Ischemia.

NCT ID: NCT02144090 Completed - Chest Pain Clinical Trials

Opsens Optowire for Fractional Flow Reserve - The O2 Pilot Study

O2
Start date: May 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the usability and safety of the Opsens OptoWire and Optomonitor in measuring fractional flow reserve (FFR) in patients with coronary artery disease who are undergoing a coronary angiogram.

NCT ID: NCT02141932 Completed - Stroke Clinical Trials

Pocket-size Cardiovascular Ultrasound in Stroke

Start date: September 2014
Phase: N/A
Study type: Interventional

Among patients admitted with cerebral ischemia (stroke and transitory ischemic attack (TIA)) it is important to reveal the underlying cause of the disease. In special it is important to reveal if carotid artery stenosis is present as such a finding will directly influence on treatment and follow-up. For the diagnosis of carotid artery stenosis due to atherosclerosis ultrasound examinations is the cornerstone, but computer tomography and magnetic resonance imaging may be better in some cases. Development of high quality pocket-sized ultrasound scanners has allowed for semi quantitatively bed-side assessment of the carotid arteries and the heart. The investigators aim to study the feasibility and reliability of bed-side assessment of the carotid arteries and the heart by pocket-sized ultrasound scanners and the clinical influence of this examination when performed by experienced users. The investigators hypothesize that a significant proportion of this patient population can be clarified bed-side with no need of further imaging procedures for the assessment of the carotid arteries and the heart.

NCT ID: NCT02140931 Suspended - Clinical trials for Critical Limb Ischemia

Assessment of Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients With Critical Limb Ischemia

Start date: August 2014
Phase: Phase 2
Study type: Interventional

A randomized, double-blind placebo controlled study to determine the safety and efficacy of Angiogenic Cell Precursors (ACPs) in relieving symptoms of Critical Limb Ischemia in patients treated with standard of care and with no surgical revascularization option. It is assumed that the ACP-treated group will have a lower amputation and death rate as compared to the placebo group. Other hemodynamic, imaging and clinical parameters will also be compared between the two groups. Quality of life assessments will also be performed.