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Constriction, Pathologic clinical trials

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NCT ID: NCT02101619 Completed - Aortic Stenosis Clinical Trials

Assessment of Myocardial Tissue Damage in Aortic Stenosis

Start date: August 2013
Phase: N/A
Study type: Observational

Aortic stenosis (AS) is the most common valve disease in the United States and most common indication for valve replacement surgery. Anatomical and hemodynamic severity of AS is insufficient for elucidating patients' prognosis. Therefore, the decision about the optimal timing of surgical intervention remains critical. However, the changes in structure and electrical activity of the cardiac muscle can be assessed by noninvasive imaging and electrocardiography (ECG). Degenerative myocardial changes characterized by fibrosis or collagen deposits are frequently observed in AS patients and have a negative impact on patient outcomes. In this project, our objective is to determine whether echocardiographic image analysis of integrated backscatter (IB), which can express changes in myocardial tissue composition (amount of fibrosis) based on its ultrasound reflectivity, global left ventricular (LV) load as measured by Zva, and ECG analysis of the duration of the QRS interval have a role in risk stratification for AS patients and to apply those methods to identify which patients would benefit from surgical intervention. The investigators hypothesize that 1) the severity of myocardial damage can discriminate the prognosis in patients with AS, and 2) IB, Zva, and QRS interval can be diagnostic measures of the severity of myocardial damage. The investigators will measure the severity of myocardial fibrosis using MRI (reference) in 50 patients and will test the diagnostic significance of IB (testing method). Zva, QRS duration, and conventional echocardiographic measures will also be tested for diagnosing severity of myocardial fibrosis.

NCT ID: NCT02093520 Completed - Clinical trials for Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

The MiDAS ENCORE Study

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

Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor.

NCT ID: NCT02089945 Completed - Aortic Stenosis Clinical Trials

Pilot Study of Cognitive and Functional Outcomes Following TAVI

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

Narrowing of the aortic valve in the heart, known as severe aortic stenosis, can impede blood delivery and is associated with poor quality of life and death. In the elderly with considerable medical burden, a relatively new non-invasive valve replacement technique called Transcatheter Aortic Valve Implantation (TAVI) can be used instead of open-heart surgery. However, long term changes in cognition after TAVI remain unclear and previous studies have suggested an increased risk of cognitive decline in patients following the surgical procedure. In this pilot study, the investigators will characterize changes in cognition, physical capacity, overall quality of life and neuropsychiatric symptoms (depression and apathy) over 6 months after TAVI.

NCT ID: NCT02079038 Completed - Clinical trials for Lumbar Spinal Stenosis

The STEPS - Totalis™ Trial

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

The purpose of this study is to determine safety and effectiveness, as measured by changes in pain, disability, patient satisfaction, and claudicatory symptoms, at 6 months following treatment with the Totalis™ Direct Decompression System or Sham Comparator Surgical Procedure in patients with lumbar spinal stenosis

NCT ID: NCT02076711 Completed - Aortic Stenosis Clinical Trials

Myocardial Efficiency of the Left Ventricle in Asymptomatic Patients With Aortic Valve Stenosis - a Prognostic Marker and a Target for Intervention?

MELVAS
Start date: June 2013
Phase: Phase 2
Study type: Interventional

Background - Aortic valve stenosis (AS) is the most common heart valve disease among adults in the Western world with a prevalence of 3 % in people older than 75 years of age. AS usually deteriorates over time leading to heart failure, with high mortality if aortic valve replacement (AVR) is not performed. Thus optimal timing of AVR is crucial, but can be challenging. Increasing life expectancy in our society will augment the therapeutic and socio economic impact of AS disease on our health care system. Therefore, new techniques for monitoring asymptomatic AS patients are needed. A potential approach is monitoring of LV myocardial efficiency (mechanical work/oxygen consumption). These measures have been suggested to be involved in the progression of non-valvular heart failure and closely related to prognosis, but never applied in a larger population of patients with AS. At present there are no recognized pharmacological treatments of AS. It is known that beta-blocker treatment in non-valvular systolic heart failure reduce heart rate, improves LV myocardial efficiency and reduces mortality. However, in patients with AS, the effects of beta-blockers are unknown. Hypotheses - Treatment with the beta-blocker metoprolol succinate in patients with asymptomatic moderate to severe AS has beneficial effects on LV myocardial oxidative metabolism, myocardial efficiency and contractile function. Objectives - To investigate if beta-blocker treatment in patients with moderate to severe, asymptomatic AS has beneficial effects on LV myocardial efficiency, contractile function and physical performance. Design - A randomized double blind placebo controlled intervention trial. 40 patients with asymptomatic AS will be randomized to either per oral metoprolol succinate (N = 20) or placebo (N= 20) for 22 weeks. Primary objective - Changes in myocardial efficiency Secondary objectives - Myocardial oxygen consumption, Myocardial perfusion at rest, LV myocardial function, LVmass, Aortic valve area and transaortic valve velocities, 6 minute walking distance, N-terminal prohormone of brain natriuretic peptide, Quality of life (estimated by Minnesota living with heart failure questionnaire), LV wall stress Methods - Patients will undergo echocardiography (resting and exercise), [11C]acetate PET and cardiac magnetic resonance imaging.

NCT ID: NCT02069847 Completed - Clinical trials for Esophageal Stricture

Prospective Evaluation of Budesonide for Prevention of Esophageal Strictures After Endotherapy

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

Surgery has been historically the mainstay treatment for advanced pre-malignant lesions and early esophageal cancers. However, esophagectomy is associated with significant morbidity and mortality. With the advance of therapeutic endoscopy, there has been a growing interest and application of endoscopic resection and mucosal ablative techniques for the treatment of these diseases. Esophageal stricture (ES) formation has become an increasingly recognized complication of extensive endoscopic mucosal ablation and/or resection. The resultant symptomatic stricture development can significantly impair a patient's quality of life. Endoscopic therapy of esophageal strictures with balloon dilation and/or local steroid injection is invasive, costly, and associated with the potential risk of perforation. Recently, oral corticosteroids have been introduced for the prevention of esophageal stricture after endoscopic submucosal dissection. Budesonide is a synthetic steroid with topical anti-inflammatory properties and high first-pass metabolism; thus, potentially less systemic absorption and side effects. Hypothesis: Oral budesonide prevents esophageal stricture formation in patients who underwent radical endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for advanced premalignant esophageal lesions or superficial esophageal cancers.

NCT ID: NCT02066623 Completed - Clinical trials for Coronary Artery Stenosis

Observational Study to Evaluate Short and Long-term Safety of the ABSORB Scaffold

GABI-R
Start date: November 8, 2013
Phase:
Study type: Observational [Patient Registry]

The German-Austrian ABSORB Register shall provide an analysis of acute and long-term safety as well as therapy outcomes of the ABSORB (trade mark) bioresorbable vascular scaffold system in patients suffering from coronary artery disease.

NCT ID: NCT02063035 Completed - Clinical trials for Lumbar Spinal Stenosis

Effectiveness Study of the Drug Tranexamic Acid to Reduce Post-surgery Blood Loss in Spinal Surgery

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

Hypothesis: Topical application of Tranexamic acid into the surgical wound during spine surgery will decrease the overall blood loss post-operatively. This reduction in blood loss will reduce the need for transfusion. In addition it will also significantly reduce the cost of the surgical procedure. Specific Aim 1: The goal of this study is to quantitatively assess whether topical application of tranexamic acid placed into the surgical wound during lumbar spine surgery will decrease post-operative blood loss, thus lowering the need for blood transfusions. By reducing the number of transfusions participants can avoid the well-known complications associated with them. The investigators do not plan on measuring serum tranexamic acid levels. Several meta-analyses and level I studies have shown that intravenous (IV) administration of tranexamic acid is effective in reducing postoperative blood loss and the need for transfusion.

NCT ID: NCT02049203 Completed - Clinical trials for Aortic Valve Stenosis

Safety of Ataciguat in Patients With Moderate Calcific Aortic Valve Stenosis

Start date: January 2014
Phase: Phase 1
Study type: Interventional

This study will determine whether Ataciguat (HMR1766) is well-tolerated in patients with mild to moderate calcific aortic valve stenosis. The primary focus of these studies will be on changes in blood pressure and orthostatic tolerance (i.e., ability to stand up without passing out), and determining whether treatment with Ataciguat results in significant reductions in blood pressure in this patient population.

NCT ID: NCT02041117 Completed - Clinical trials for Intracranial Arterial Stenosis

Resuvastatin Treatment for Symptomatic Middle Cerebral Artery Stenosis Based on High-resolution Magnetic Resonance Imaging

REALM
Start date: February 24, 2014
Phase: Phase 4
Study type: Interventional

1. It is a multicenter, open-label, sing arm study to evaluate the effects of treatment of Rosuvastatin 10-20mg in volume and morphology of atherosclerotic plague by reducing LDL-C level to or less than 70mg/dl. 2. Ischemic stroke patients will be enrolled within 1 month after stroke onset. 3. Patients will be visited at 0m, 1m, 3m, 6m, 9m, 12m, 18m and 24m.