View clinical trials related to Ischemia.
Filter by:The aim of the RIMINI-Trial is to examine the effect of Ranolazine on ischemic myocardium in acute myocardial ischemia. A pilot-trial by Venkatamaran et al. recently demonstrated, that the area of ischemic myocardium in patients with stable coronary artery disease can be reduced by Ranolazine-treatment2. This effect was shown by significantly reduced areas of atypical or dysfunctional myocardium in SPECT-examinations. The dimension of myocardial damage (i.e. area of ischemic myocardium) is directly related to the rate of complications (i.e. left-ventricular pump failure, malignant arrhythmia) and the grade of Rehabilitation to daily life (i.e. persistent reduced left-ventricular ejection fraction). In patients with stable angina pectoris, Ranolazine is used with beneficial results1. Ranolazine improves diastolic blood flow and therefore microcirculation in the myocardium by reducing diastolic tension (via inhibiting late Na+-Influx and consecutive Ca2+-Overload). Recently published data2 showed that treatment with Ranolazine significantly reduces the ischemic area in chronic damaged myocardium. This is due the effect of improved microcirculation in hibernating myocardium. Early administration of Ranolazine and improvement of microcirculation in patients with acute damaged myocardium (i.e. directly after acute ischemia) should lead to a recruitment and re-uptake of cardiac activity of hibernating myocardium. For the RIMINI-Trial patients are given Ranolazine on top of the guideline-based treatment to reduce the area of acute ischemic myocardium. Patients with unstable angina pectoris and proof of acute cardiac ischemia, proof of myocardial dyskinesia and angina pectoris in the patient history will receive unaltered guideline-based therapy for acute cardiac ischemia5,6. All necessary procedures will be performed to stabilize patients to a hemodynamically compensated state and patients are then transferred to receive cardiac catheterization (angiography and angioplasty if necessary). After patients are stabilized Ranolazine will be given additionally to guideline based medication. The measurement of the ischemic myocardial area will be done via three functional echocardiographies with speckle tracking technique10. A statistical evaluation of ischemic myocardial area before and after treatment with Ranolazine/Placebo will be done after conclusion of the RIMINI-Trial to show the effect of Ranolazine in acute myocardial ischemia.
The objective is to investigate the effect of a comprehensive sexual rehabilitation program, consisting of a psycho-educative component and a physical exercise component. The primary hypothesis is that, a comprehensive sexual rehabilitation program improves sexual function.
Severe atherosclerosis in the leg arteries is termed critical limb ischemia (CLI). This condition gives great suffering for the patients in terms of pain, wounds and often developing gangrene. Untreated, the condition has a high risk of amputation. In Sweden, the majority of the patients are investigated and evaluated for treatment. Treatment is carried out either by traditional open bypass surgery or balloon dilatation technology (endovascular treatment). The latter method is still under development, and studies have shown that the treatment has less local and systemic complications than bypass surgery. It is also shown that the method has a limitation in that the treatment effect is less durable. What is the role of minimally invasive technologies should have in the future is unclear, mainly due to its efficiency and cost-effectiveness compared with bypass surgery are not evaluated. In a prospective observational study we intend study the effectiveness, cost-effectiveness and impact on quality of life in patients undergoing treatment for critical CLI with bypass surgery or endovascular treatment in Västra Götaland Region (VGR). All patients over a period of two years, which undergo treatment for CLI with either of the two methods will be included in the study. Patients will be followed up with regard to the clinical efficacy and health-related quality of life after treatment at, respectively one, 12 and 24 and 60 months. Cumulative care costs are calculated and estimates of cost are made. This study aims to increase knowledge about the role of endovascular treatment of CLI shall have in the future.
This study is a randomized, controlled trial to assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at <6 hours postnatal age with moderate to severe neonatal encephalopathy (NE). The study will enroll infants with signs of NE at 18 NICHD Neonatal Research Network sites, and randomly assign them to either receive hypothermia or participate in a non-cooled control group.
This is a 3-arm, prospective, randomized, double-blind, and controlled clinical study, with 3 months of treatment to evaluate efficacy of DLBS1033 in bleeding profile and clinical outcome in patients with acute ischemic stroke compared with aspirin and clopidogrel, as active controls.
This is a randomized, placebo-controlled, single-center clinical trial investigating the effectiveness of administrating intravenous Cerebrolysin™ (EVER NEURO Pharma, Austria), a preparation of low-molecular weight neurotrophic peptides and free amino acids, in improving the functional outcome of patients suffering from aneurysmal subarachnoid haemorrhage ( SAH). Cerebrolysin™ is a porcine-derived intravenous formulation composed of multiple lipid-soluble active agents that can cross the blood-brain barrier. It is a registered medication in several countries indicated for stroke and Alzheimer's disease. It contains several low molecular weight neuropeptides and free amino acids that possess neuroprotective and neurotrophic properties. It has been proven to arrest or mitigate several crucial steps along the ischemic cascade in preclinical studies. Cerebrolysin™ has been extensively investigated in patients suffering from Alzheimer's disease, brain trauma and ischemic stroke with promising clinical results. It's use in SAH patients has never been investigated and it is believed that it may play a role in improving clinical outcomes. Consecutive patients aged 18 to 70 years-old diagnosed to have spontaneous subarachnoid hemorrhage secondary to a ruptured intracranial aneurysm will be randomly allocated into one of two study arms: (1) to receive intravenous Cerebrolysin™ in additional to standard of care (intervention group) or (2) to receive usual standard of care alone (control group). Permuted-block randomization will be carried out once the eligibility criteria have been fulfilled using a computer system with an allocation list of random order. Instructions on study arm allocation will be contained in sealed envelopes labeled with sequential study numbers. Patients presenting beyond 96 hours after onset of symptoms or if recruitment and randomization cannot be performed within this time period will be excluded. The reason being that post-SAH arterial vasospasm and delayed cerebral ischemia usually occurs four days after aneurysm rupture and lasts for two weeks i.e. 14 days. Should this complication arise before Cerebrolysin™ is administered there would be significant confounding of trial outcome measures . The timing of intervention is in keeping with several landmark clinical studies that have dealt with neuroprotective agents in subarachnoid hemorrhage. Patients in the intervention group will receive in a daily total dose of 30ml of intravenous Cerebrolysin™. The study medication will be administered in three separate 10ml doses (every eight hours) diluted in 0.9% NaCl saline to a total volume of 100 ml as an intravenous infusion over a time period of 15 minutes. An identical amount of 0.9% sodium chloride (NaCl) saline (100 ml) will be used as placebo for patients allocated to the control study group. The total duration of study medication or placebo administration will be 14 days. Cerebrolysin™ is a clear yellow solution. Since it is susceptible to photo-degeneration the preparation after dilution with 0.9% NaCl saline requires masking with a opaque plastic wrap as well as special photo-protective infusion sets. The dilution of the Cerebrolysin™ solution will be performed by ward nursing staff . Subjects in both trial groups will receive identically wrapped preparations so that both the functional outcomes assessor and patient are blind to the study arm allocation. In addition to general demographic data, clinical data including the admission Glasgow Coma Score, severity grading of SAH, hospital stay as well as the extended Glasgow Outcome Score and modified Rankin Score upon discharge, at three months and six months will be prospectively collected. The functional outcomes assessor will be an occupational therapist unaware of the subject's trial group allocation. Hypothesis: compared to patients receiving standard care for the management of aneurysmal subarachnoid hemorrhage alone (control), the additional administration of intravenous Cerebrolysin™ (intervention) within the acute phase of stroke is safe and improves functional outcome at six months after stroke.
Acute ischemic stroke affects roughly 1 in 50,000 children every year and is one of the top ten causes of death in children. Currently, caregivers lay the affected child flat in hopes of increasing blood flow to the brain and reducing the volume of the brain which is damaged. However, there are currently no techniques to measure brain blood flow at the child's bedside and indicate if this treatment is effective. We will probe brain blood volume, oxygen saturation, and flow with red light to determine the efficacy of this intervention.
To evaluate the effect of the dynamic combination therapy on Chinese herbal granule formula (Fangji) based on differentiation of syndromes ("Zhenghou") according to the theory of traditional Chinese medicine for improving the symptoms in the convalescent phase of ischemic stroke, and to establish the pharmacodynamic model of "Zhenghou" according to the results of this trial.
Objective: Demonstrate the safety of early use of dabigatran following TIA/minor stroke. Background: Although aggressive antithrombotic therapy has been shown to reduce the number of new ischemic events following stroke/TIA, this has always been offset by an increase in the risk of hemorrhagic transformation. Dabigatran is much safer than previously tested antithrombotic agents, with respect to intracranial bleeding and therefore offers a unique treatment opportunity in these high-risk patients. TIA/minor stroke represent the largest group of cerebrovascular disease patients. A short-term intervention such as 30 days of dabigatran treatment has the potential for a very large impact from the population health perspective, given the number of patients who may be treated if a benefit can be demonstrated. Study design: This is an open label, single arm study. Patients with TIA/minor stroke (National Institutes of Health Stroke Scale (NIHSS) score </=3) who can be treated within 24 hours of symptom onset will be eligible. All patients will be treated with dabigatran for 30 days. The dose of dabigatran will be determined by age and renal function (patients >80 years old and/or with GFR 30-50 ml/min will received 110 mg bid, and all other patients will receive 150 mg BID).The primary endpoint is symptomatic hemorrhagic transformation. Patients (n=50) with TIA/minor stroke, defined as having a National Institutes of Health Stroke Scale Score of </=3, will undergo an MRI, including diffusion-weighted imaging (DWI), as well as gradient recall echo (GRE) sequences, which will be used to assess for hemorrhagic transformation. Patients will have a repeat MRI examination at 7 and 30 days to assess for hemorrhagic transformation and new lesion development. The primary endpoint of of phase I is symptomatic hemorrhagic transformation, defined as a parenchymal hematoma on the day 7 MRI scan (GRE sequence), associated with clinical worsening (>/=4 point increase in National Institutes of Health Stroke Scale (NIHSS) score). If dabigatran can be used safely in this population, a second phase aimed at demonstrating the rate of new ischemic lesion development following TIA can be reduced with aggressive antithrombotic therapy. A randomized open-label, blinded endpoint evaluation design will be employed. The investigators hypothesize that dabigatran therapy administered within 24 hours of symptom onset will reduce the rate of new ischemic lesions, relative to standard care, one week and 30 days after onset.
This is a 20-week study consisting of a 12-week multicenter, randomized,double-blind adaptive study to compare efficacy and safety of Qizhitongluo Capsule,Naoxintong Capsule and placebo in the recovery phase of ischemic stroke with qi deficiency and blood stasis syndrome, and a 8-week post-treatment safety follow-up.After 312 patients complete 12 weeks of treatment there will be an interim analysis.