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NCT ID: NCT00721032 Withdrawn - Clinical trials for Ventricular Tachycardia

Anti-arrhythmic Medication v. MRI-Merge Ablation in the Treatment of Ventricular Tachycardia

Start date: June 2012
Phase: N/A
Study type: Interventional

Ventricular tachycardia (VT) is a morbid arrhythmia responsible for many sudden deaths and ICD shocks. Despite much progress in the treatment of arrhythmia, VT remains a therapeutic challenge. Most patients with VT have an implantable cardioverter defibrillator (ICD) for secondary prevention of sudden cardiac death, however, an ICD merely treats VT, it does not prevent VT. In patients with recurrent VT and ICD shocks, two strategies are available to decrease the burden of VT. The first is antiarrhythmic drugs, and the second is VT ablation. The aim of this study is to compare the efficacy of antiarrhythmic drugs and VT ablation guided by MRI. VT can sometimes be suppressed with antiarrhythmic medications, however, these are often ineffective, and carry a high burden of side effects. Many forms of VT can be cured by selective destruction of critical electrical pathways with catheter ablation. A major limitation in the ablation of VT, however, is the time required to localize scar tissue and important pathways for targeting of lesions. Magnetic resonance imaging can now obtain reliable images of scar location within the ventricles. Recent advances in electroanatomical mapping systems allow operators to import pre-acquired images into the mapping system. The aim of this study is to examine the feasibility of importing historic MRI scar maps of the ventricles into the electroanatomical system and using such images to guide catheter ablation, as compared to antiarrhythmic drug suppression of VT. We suspect that MRI guidance will be especially useful in patients with "unstable" VT, i.e. VT that causes an abrupt drop in blood pressure, and thus cannot be maintained in the electrophysiology (EP) lab for mapping and entertainment purposes. Patients referred for VT ablation have ICDs. Through previously completed animal work (Circulation 2004; 110(5): 475-82) and a human trial (2006 Sep 19;114(12):1277-84) we have demonstrated the safety of MRI in the setting of pacemakers and implantable defibrillators using appropriate precautions. Through careful device programming and using MRI sequences with limited energy exposure (specific absorption rate < 2 W/kg) we will study the pre procedural myocardial anatomy of patients enrolled into this study. The primary endpoint will be lack of VT documented by implantable defibrillator (when present) interrogation or Holter monitoring 6 months post ablation. The secondary endpoints will be comparison of inducible arrhythmia at the end of the procedure, procedure time, comparison of endocardial voltage mapping to scar on delayed enhancement MRI images, and complications in each study arm.

NCT ID: NCT00720616 Withdrawn - Metabolic Syndrome Clinical Trials

Low Dose Growth Hormone Treatment in Subjects With Metabolic Syndrome.

Start date: October 2010
Phase: N/A
Study type: Interventional

Study hypothesis: Low dose growth hormone (GH), through its generation of free 'bioavailable' insulin-like growth factor (IGF)-I, can improve insulin sensitivity and the metabolic profile of subjects with metabolic syndrome. Study aims: The purpose of this study is to determine the mechanism of how low dose GH treatment affects the body's sensitivity to insulin actions and whether this low GH dose can affect the body's handling of steroid hormone levels (cortisol clearance) and fat deposition in subjects with metabolic syndrome. Study design: Subjects that satisfy the criteria of metabolic syndrome (central obesity, treated or untreated high blood pressure, high cholesterol and impaired fasting glucose levels) will be invited to participate in this study. The subjects will be assessed at the initial visit to ascertain their suitability before further participation in the study. If eligible, an equal number of men and women will be randomized (like a flip of a coin) to receive either daily low dose GH or placebo injections first for 12 weeks, before exchanging over for another 12 weeks of treatment after a 4-week washout period. Before, during and after treatment, the subjects will be assessed at frequently with blood tests, scans and fat biopsies. During the study, the subjects will be studied 4 times at the Oregon Clinical and Translational Research Institute (OCTRI). At the first, second and final visit, testing will include scans to measure the amount of whole body fat and fat in the stomach area, muscle, and liver; blood tests to measure levels of cortisol, and fat tissue (taken from a biopsy) analysis to measure the density of insulin-like growth factor-I (a hormone stimulated by growth hormone in the body) in fat; whereas blood tests to examine how well insulin works in the body (insulin sensitivity) will be collected at all visits of the study.

NCT ID: NCT00720395 Withdrawn - Bipolar Disorder Clinical Trials

Identifying Predictors of Bipolar Disorder Relapse During Pregnancy and the Postpartum Period

Start date: August 2005
Phase: N/A
Study type: Observational

This study will evaluate pregnant women who have bipolar disorder to gain a better understanding of risk factors for bipolar disorder relapse during pregnancy and the postpartum period.

NCT ID: NCT00719082 Withdrawn - Balance, Falls Clinical Trials

Fall Prevention:Dynamic Posturographic Measurements in the Geriatric Population

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

Falls are the greatest cause of accidental death in the elderly. There is no normative data on large groups of geriatric subjects specific to their stability scores obtained by computerized dynamic posturography (CDP). CDP is the standard test to obtain stability scores and is utilized as the gold standard in posturographic evaluations and fall prevention Hypotheses: Human stability can be measured by CDP. Increased stability is associated with a lessor probability of falls. Stability decreases as age increases and a normative data collection of stability scores in the geriatric population will allow and promote clinical applications which can be utilized in fall prevention.

NCT ID: NCT00716404 Withdrawn - Clinical trials for Targeted Renal Therapy

Post-Market Observational Study of Intra-Renal Drug Delivery

PROVIDE
Start date: April 2008
Phase: N/A
Study type: Observational

This is a prospective, observational, multi-center study with consecutive enrollment. Up to 1,000 patients will be enrolled. The objective of this post-marketing surveillance study is to collect clinical usage patterns of the Benephit Infusion Systems. As a result, FlowMedica will be able to: 1. Better understand and quantify usage patterns including patient characteristics, adjunctive procedures, and infusion agents. 2. Collect user-interface information and overall customer satisfaction. 3. Monitor post-marketing device performance.

NCT ID: NCT00715715 Withdrawn - Chronic Hepatitis B Clinical Trials

Efficacy Study of Prednisone Priming to Treat Asian Chronic Hepatitis B Patients

Start date: April 2008
Phase: N/A
Study type: Interventional

Patients with chronic hepatitis B constantly produce the virus in the body. The disease of chronic hepatitis B is the body responding to the virus. Use of steroids can adjust this response. After taking steroids, viral production usually increases and liver function tests increase. After stopping steroids, viral production usually decreases. Many studies in the past have studied taking a low dose steroid before treating hepatitis B. Those studies have shown that low dose steroids help your body to clear the virus. The goal of this study is to improve the liver function by slowing viral growth.

NCT ID: NCT00715364 Withdrawn - Stroke Clinical Trials

REGENESIS (US): A Phase IIb Prospective, Randomized, Double-blind, Placebo Controlled Study of NTx™-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients

REGENESIS
Start date: August 2009
Phase: Phase 2
Study type: Interventional

To assess the safety and tolerability of NTx™-265 when given to acute ischemic stroke patients. To assess the neurological outcome in acute ischemic stroke patients treated with NTx™-265, when compared with patients given a placebo control.

NCT ID: NCT00715065 Withdrawn - Syncope Clinical Trials

fMRI in Blood Phobia Syncope

Start date: June 2010
Phase: N/A
Study type: Observational

We plan to study patient who faint in response to the sight of blood and compare them to healthy subjects who do not. We are going to use a special type of MRI scan (functional MRI) to determine if there are differences in brain activation in response to seeing bloody or gory pictures that occur before the fainting occurs.

NCT ID: NCT00713921 Withdrawn - Clinical trials for Urinary Incontinence

Neuropathic Investigation and Anticholinergic Treatment of Bladder Dysfunction in Diabetes and Stroke Patients

Start date: September 15, 2009
Phase: Early Phase 1
Study type: Interventional

Develop and quantify methods for evaluating bladder dysfunction in diabetes and stroke

NCT ID: NCT00712621 Withdrawn - Breast Carcinoma Clinical Trials

Determining Quality of Life in Breast Cancer Patient After Completing Radiation,Chemotherapy,Surgery or Combination

Start date: February 2010
Phase: Phase 2
Study type: Interventional

Rationale: Determining quality of life in breast cancer patient after completing chemotherapy or radiation therapy or surgical procedures or any combination therapy. Intervention includes supportive care in terms of psychological support and moral boosting efforts by counseling breast cancer survivors which may enhance the well-being and quality of life of women who are treated with chemotherapy or radiation therapy or surgical procedures or any given combination therapy. PURPOSE: Randomized clinical trial study to compare the effectiveness of support system and counseling of breast cancer survivors on the well-being of women, who have completed various modes of treatment of breast cancer with the subjects who have no support system. Study Type: Quality of life and survival Study Design: Two arm randomized controlled clinical trial to study quality of life and survival of breast cancer patients after completion of chemotherapy or radiation therapy or surgery or any combination therapy. The stages from I to IV (metastases to other sites of the body) are included.