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Ischemia clinical trials

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NCT ID: NCT02222714 Completed - Ischemic Stroke Clinical Trials

Safety Evaluation of 3K3A-APC in Ischemic Stroke

RHAPSODY
Start date: October 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study was to evaluate the safety, pharmacokinetics (PK) and preliminary efficacy of multiple ascending intravenous doses of 3K3A-APC, a Recombinant Variant of Human activated protein C (APC), in in the treatment of acute ischemic stroke following treatment with recombinant tissue plasminogen activator (tPA), mechanical thrombectomy or both.

NCT ID: NCT02216643 Completed - Stroke Clinical Trials

EndoVascular Treatment With Stent-retriever and/or Thromboaspiration vs. Best Medical Therapy in Acute Ischemic Stroke

RESILIENT
Start date: February 8, 2017
Phase: Phase 3
Study type: Interventional

Prospective, multi-center, randomized, controlled, open, blinded-endpoint trial with a sequential design. The randomization employs a 1:1 ratio of mechanical thrombectomy with stentriever and/or Thromboaspiration versus medical management alone. Randomization will be done under a minimization process using age, baseline NIHSS, use of IV tpa, vessel occlusion site and hospital. To evaluate the hypothesis that mechanical thrombectomy is superior to medical management alone in achieving more favorable outcomes in the distribution of the modified Rankin Scale scores at 90 days in subjects presenting with acute large vessel ischemic stroke <8 hours from symptom onset. Subjects are either ineligible for IV alteplase or have received IV alteplase therapy without recanalization. Sample size is projected to be 690 patients for a difference in treatment effect of 10%.

NCT ID: NCT02212912 Completed - Ischemic Stroke Clinical Trials

Intervention to Bridge the Evidence-based Gap in Stroke Care Quality

GoldenBridge
Start date: August 10, 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate whether a multifaceted quality improvement intervention can improve the adherent rate of individual and composite of evidence-based performance measures for patients with acute ischemic stroke within the first 7 days of symptom onset and reduce the incidence of a new clinical vascular event, disability, and all-cause mortality at discharge and long term clinical outcome.

NCT ID: NCT02212470 Completed - Clinical trials for Cardiovascular Diseases

Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral Artery

PAVENST
Start date: July 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment.

NCT ID: NCT02207283 Completed - Clinical trials for Becker Muscular Dystrophy

PDE5 Inhibition to Alleviate Functional Muscle Ischemia in Becker Muscular Dystrophy

Start date: March 2012
Phase: Phase 4
Study type: Interventional

This study is intended to build on recent findings from our laboratory showing that a single dose of tadalafil (also known as Cialis) restored normal blood flow regulation in men with Becker muscular dystrophy. The investigators now wish to extend these findings by showing that the same dose of tadalafil will also prevent muscle injury and fatigue. Patients will take a single dose of tadalafil prior to exercising. Then doctors will measure whether the patients muscles receive more blood flow and are better protected during exercise.

NCT ID: NCT02198183 Completed - Cerebral Ischemia Clinical Trials

Total Shoulder Arthroplasty Near-infrared Spectroscopy

TSA NIRS
Start date: July 2014
Phase:
Study type: Observational

The purpose of this study is to measure cerebral oxygenation and cardiac output of total shoulder replacement patients undergoing general anesthesia (GA) and positive-pressure ventilation (PPV). We hypothesize that cerebral desaturation occurs frequently during GA with PPV, but is rare during GA and spontaneous ventilation. We also hypothesize that cardiac output usually is well maintained under GA in the sitting position when epinephrine is used, but that decreased cardiac output increases the risk of cerebral desaturation.

NCT ID: NCT02197065 Completed - Inflammation Clinical Trials

Pilot Study of Atorvastatin for Orthopedic Surgery Patients

POST-OP Pilot
Start date: September 2014
Phase: Phase 2
Study type: Interventional

Up to 35% of hip fracture patients have been shown to experience heart injury after surgery, and as many as 10% have a heart attack or die in the three months after surgery. Hip and knee arthroplasty patients are also at risk of cardiovascular complications. Patients who have these complications have higher levels of inflammation postoperatively. Statins (such as atorvastatin/Lipitor) lower cholesterol and also lessen inflammation. Both of these effects are important in preventing heart attacks. Statins have been shown to reduce the risk of heart attacks in non-surgical patients, and to protect from heart attacks in patients having heart surgery. Whether statins can prevent heart attacks in orthopedic patients is not known. In this pilot study the investigators will treat 30 orthopedic surgery patients (hip fracture, hip or knee arthroplasty) with either atorvastatin or placebo (a capsule with no study drug). Patients will start the study drug prior to surgery and take it for 45 days after surgery. Neither the doctors nor the patients will know whether they are taking atorvastatin or placebo. The investigators will look for evidence of inflammation and heart injury after surgery. The investigators hypothesize that atorvastatin will lessen the degree of postoperative inflammation found in these patients. In this study, the investigators will use a very sensitive test of heart injury that can detect problems even when patients have no symptoms. The investigators hypothesize that this test will demonstrate silent heart injury in over 50% of the hip fracture patients and over 30% of arthroplasty patients in our study. The results of this trial will help us to develop a larger study in 1000 hip fracture and joint replacement patients to determine whether atorvastatin protects orthopedic surgery patients from heart injury and other complications of surgery.

NCT ID: NCT02184936 Completed - Ischemic Stroke Clinical Trials

Measuring Collaterals With Multi-phase CT Angiography in Patients With Ischemic Stroke

PRove-IT
Start date: September 2012
Phase: N/A
Study type: Observational

Treatment of acute ischemic stroke (AIS) is aimed at salvaging viable but ischemic brain by opening the occluded artery and restoring anterograde perfusion as quickly as possible. Time saved while making critical decisions correctly is vital in AIS management. Conventional angiography is invasive, resource intensive and not feasible as a fast diagnostic tool. Perfusion CT and MRI are both susceptible to patient motion, need trained personnel to process and take at least 10-30 min to acquire and interpret. The investigators have developed a new imaging tool, multi-phase CT Angiography (CTA), which generates multiple time resolved images of backfilling arteries beyond a blocked artery filled by collaterals. Investigators seek to determine: i) if patients with AIS will have a differential clinical response to early recanalization based on collateral status assessed on multi-phase CTA, ii) if the extent to which collateral assessment on multi-phase CTA resembles perfusion CT in predicting which patients will have good clinical outcome with early recanalization, iii) Identify determinants of variability in native collateral status in patients with acute ischemic stroke. Investigators hypothesize that patients with good and intermediate collaterals on multi-phase CTA achieve good clinical outcome with early recanalization (within 4 hours of baseline imaging); patients with poor collaterals do not do well even with early recanalization. Prove-IT is a prospective multi-center hospital-based cohort study of 500 consecutive patients with acute ischemic stroke presenting within 12 hours of stroke symptom onset with evidence of intracranial occlusion on routine CTA over 3 years. Calgary and seven other comprehensive stroke centers will recruit patients into this study. Primary outcome is defined as a National Institute of Health Stroke Scale (NIHSS) score of 0 to 2 at 24 hours or an 8-point drop in NIHSS score from baseline to 24 hours. Secondary outcomes are a) 90-day modified Rankin Score (mRS) 0-2 or equal to the pre-stroke mRS; b) percent neurologic improvement comparing NIHSS at baseline to 24 hours; c) 90-day NIHSS score 0-2; d) infarct volume on 24 hour imaging and e) parenchymal intracerebral hemorrhage type 1 and 2 (ECASS II criteria) at 24 hrs. Prove-IT looks to establish the ideal imaging selection tool for intra-arterial (IA) and thrombolysis decisions in the setting of AIS which is widely available, and can quickly and reliably detect salvageable brain.

NCT ID: NCT02178904 Completed - Ischemia Clinical Trials

Dual Energy CT for Ischemia Determination Compared to "Gold Standard" Non-Invasive and Invasive Techniques

DECIDE-Gold
Start date: March 2014
Phase:
Study type: Observational

The purpose of this study is determine the diagnostic performance of dual energy computed tomography perfusion for non-invasive assessment of the hemodynamic significance of coronary stenosis, as compared to a direct measurement of fraction flow reserve during cardiac catheterization as a reference standard. The overall objective of the present study is to determine the diagnostic performance of dual energy computed tomography perfusion for non-invasive assessment of the hemodynamic significance of coronary stenosis, as compared to direct measurement of fraction flow reserve during cardiac catheterization as a reference standard.

NCT ID: NCT02178657 Completed - Ischemic Stroke Clinical Trials

Intra-arterial Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke

Start date: April 2015
Phase: Phase 2
Study type: Interventional

This trial aims to test that intra-arterial injection of autologous bone marrow mononuclear cells in acute ischemic stroke patients is safe and improves neurological outcomes.