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Vascular Diseases clinical trials

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NCT ID: NCT01417910 Completed - Vascular Diseases Clinical Trials

Predictors of Post Operative Outcome in Peripheral Vascular Surgical Patients

Start date: September 2011
Phase: N/A
Study type: Observational

Over 3000 people each year undergo bypass operations to their lower limbs, and these operations carry significant risks with approximately 1 in 20 of these people dying in hospital, and another 1 in 20 having a heart attack. Assessment of these patients in order to stratify their risk of both dying and having significant complications aid in improving their care, enable better utilisation of scarce critical care resources, and allow us to give patients better information on which to base consent. Aims The aims of the project are to assess the feasibility of exercise testing this group of patients both with cycle and arm exercise, and to identify markers of outcome in this group. Methodology This is a prospective observational study designed to test the hypothesis that a combination of cardiopulmonary exercise testing and blood tests provides prognostic value on outcome measures after surgery for lower limb revascularisation Subjects will have 2 exercise tests, one arm and one cycle, prior to surgery at their preoperative assessment appointment. From these tests we will measure how much work patients can do, how much oxygen they are able to use, and when the heart is unable to deliver enough oxygen to the cells. In addition they will have blood samples taken prior to the operation (brain natriuretic peptide), and on days 1 and 3 (troponin I) after the operation to look at cardiac markers of damage. This data will be used to see if we can predict those patients that have both short and long term complications, and also to see whether the different forms of exercise testing are comparable, or if one type is superior. Expected outcomes We expect that through a combination of exercise testing and blood test we will be able to identify patients at increased risk of complications after surgery. We also expect to find that arm exercise will be a more feasible and informative test that cycle exercise.

NCT ID: NCT01413139 Completed - Clinical trials for Peripheral Vascular Disease

4-EVER : a Trial Investigating the Safety of 4F Endovascular Treatment of Infra-Inguinal Arterial Stenotic Disease

4-EVER
Start date: July 2010
Phase: Phase 4
Study type: Interventional

The objective of this clinical investigation is to evaluate puncture site complication rate as well as the short- and long-term (up to 24 months) outcome of treatment by means of Astron Pulsar / Astron Pulsar-18 stent implantation in symptomatic (Rutherford 2-4) femoro-popliteal arterial stenotic or occlusive lesions, using 4F compatible devices of BIOTRONIK and without the use of a closure device. The hypothesis is that the primary patency at 12 months is non-inferior to the primary patency obtained in the Durability study (72.2%).

NCT ID: NCT01404767 Terminated - Hypertension Clinical Trials

Tight Hemodynamic Control in Patients Who Are Chronically on Metoprolol

Start date: April 2011
Phase: Phase 4
Study type: Interventional

This study proposes to assess the effect of the standard of care, which is continuation of the pre op beta blocker dose into the post operative period compared to the administration of esmolol titrated to a pre determined target HR. The primary outcome will compare postoperative plasma levels of metoprolol in 2 cohorts in a group who has been continued on metoprolol (administrated via a nasogastric tube in NPO patients) to a group who has been withdrawn from metoprolol but given an esmolol infusion titrated to HR. Secondary outcomes will compare a) the hemodynamic responses, documenting the incidence of unplanned hypotension and bradycardia and b) to compare the effects of Heart rate to the incidence of myocardial ischemia, arrhythmias, delirium and infarction.

NCT ID: NCT01404078 Completed - Clinical trials for Type 2 Diabetes Mellitus

Study to Compare 2 Doses of Polycap Versus Single Dose of Polycap With or Without Pottasium

TIPSK
Start date: April 2010
Phase: N/A
Study type: Interventional

This is a randomized double blind 2x2 factorial controlled trial to evaluate efficacy tolerability of low strength Polycap versus two doses of low strength Polycap in patients with stable cardiovascular disease in reducing blood pressure and LDL. To evaluate the tolerability and safety of low dose potassium supplementation compared to placebo in patients with stable cardiovascular disease. Approximately 500 patients are planned to be randomized.

NCT ID: NCT01403142 Completed - Clinical trials for Cardiac Allograft Vasculopathy

Optical Coherence Tomography (OCT) to Evaluate Cardiac Allograft Vasculopathy (CAV) in Patient's Post Heart Transplant

OCTCAV
Start date: August 18, 2011
Phase: N/A
Study type: Observational

Cardiac allograft vasculopathy (CAV) is a unique form of accelerated plaque formation seen in the coronary arteries of patients who have received heart transplantation. It is a major cause of morbidity and mortality in patients after heart transplant. Little progress has been made in characterizing this disease process, with more sophisticated imaging allowing for more detailed analysis of CAV, superior stratification of transplant recipients is possible and earlier interventions can be performed if necessary to prevent mortality and graft loss. Optical Coherence Tomography (OCT) is a novel imaging modality with much higher resolution then Intra-Vascular Ultrasound (IVUS). This study will involve examining patients post-heart transplant using this high-resolution imaging modality. It is currently the standard care for patients post-heart transplant to receive annual coronary angiograms with close follow up. Patients will be imaged using OCT at the time of their routine annual angiogram, and will be re-imaged one year later at the time of the next annual angiogram or earlier if clinically indicated. The study goal is to better characterize CAV in vivo with OCT imaging and to try to identify patterns of the disease, including intra-coronary risk assessment.

NCT ID: NCT01396525 Completed - Clinical trials for Peripheral Vascular Disease

Trial to Evaluate the Safety & Efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery

MOBILITY OE
Start date: March 2009
Phase: Phase 3
Study type: Interventional

To determine the safety and efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native common iliac artery and/or native external iliac artery.

NCT ID: NCT01386216 Completed - Clinical trials for Critical Limb Ischemia (CLI)

Safety Study of Bone Marrow Cell Concentrate Prepared Using the Magellan System to Treat Critical Limb Ischemia (CLI)

CLI
Start date: April 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety of administration of marrow-derived autologous hematopoietic stem cells (HSC) concentrate and platelet-rich plasma (PRP) gel for the treatment of Critical Limb Ischemia (CLI).

NCT ID: NCT01360151 Recruiting - Clinical trials for Polypoidal Choroidal Vasculopathy

Aqueous Humor Level of Cytokines in Polypoidal Choroidal Vasculopathy and Change of Cytokines After Photodynamic Therapy

Start date: February 2011
Phase: N/A
Study type: Interventional

This is a prospective, comparative control analysis. The investigators want to evaluate the aqueous humor levels of vascular endothelial growth factor in polypoidal choroidal vasculopathy and the effect of photodynamic therapy and combination treatment of photodynamic therapy and Lucentis (Ranibizumab)on the level of vascular endothelial growth factor.

NCT ID: NCT01358630 Recruiting - Periodontitis Clinical Trials

Vascular and Periodontal Disease - Microbial, Genetic and Histological Causalities

Start date: October 2008
Phase: N/A
Study type: Observational

The purpose of this study is to analyze genetic polymorphisms in genes encoding pro-inflammatory cytokines, and study the genetic predisposition to chronic periodontitis (CP) in combination with atherosclerotic cardiovascular (ACD) and aneurysmal diseases. The investigators will also try to identify oral bacteria in atherosclerotic plaques and aneurysmal walls and thrombus. Histological analyses of atherosclerotic plaques and aneurysmal wall will be performed.

NCT ID: NCT01355406 Completed - Clinical trials for Cardiovascular Diseases

Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System

OPEN
Start date: September 16, 2011
Phase: N/A
Study type: Interventional

This is a clinical study of a new self-expanding stent (FlexStent®) designed specifically to cope with the extreme demands of the superficial femoral artery (SFA)/proximal popliteal artery. The arteries are often abbreviated as femoropopliteal. The intent of this study is to demonstrate that the FlexStent® Femoropopliteal Self-Expanding Stent System is safe and effective for the treatment of patients with peripheral arterial disease. Specifically, the FlexStent® shall meet or exceed the proposed safety and efficacy performance goals established for Femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease.