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Arteritis clinical trials

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NCT ID: NCT00361192 Recruiting - Temporal Arteritis Clinical Trials

Sensitivity and Specificity of Color Doppler Directed Temporal Artery Biopsy as Compared to Standard Random Biopsy in the Diagnosis of Temporal Arteritis

Start date: August 2006
Phase: Phase 0
Study type: Interventional

Introduction Temporal arteritis (TA) is the most common primary vasculitis in the adult population. TA is a systemic multi-organ disease but primarily involves the cranial arteries, especially the temporal artery. The signs and symptoms of the disease are variable and therefore the differential diagnosis is often difficult. The annual incidence of the disease in the population above the age of 50 in Jerusalem is about 10 per 100,000. Diagnosis is based on the clinical findings and confirmed by biopsy of the temporal artery, positive for histologic findings of arteritis. Though the biopsy procedure is minor and can be accomplished under local anesthesia, it is not without morbidity. Along with minor pain, more serious complications - facial nerve injury, ptosis, stroke, and local necrosis of skin - have been reported. A negative biopsy does not completely rule out the diagnosis of TA because of the segmental nature of the inflammation. Even if one removes an appropriate length of artery (usually 1-2 cm) the possibility exists that an involved segment may not have been included and the biopsy will be reported as normal. It has recently been reported that color Doppler ultrasonography can be used to diagnose TA. Arterial inflammation causing peri-vascular edema appearing as a "dark halo" and segmental stenosis of the temporal artery are characteristic ultrasound findings suggestive of TA. If there is no dark halo sign, a diagnosis of TA cannot be supported and temporal artery biopsy can be avoided in most of these patients. The presence of the dark halo sign has a positive predictive value of only 50%. As noted above the disease is characterized by segmental involvement of the artery and to avoid a false negative biopsy, excision of up to 3cm of the artery has been recommended, thereby increasing the morbidity, and leading patients to refuse the procedure. Use of ultrasound-guided biopsy of the artery may dramatically raise the sensitivity and specificity of the biopsy and reduce the requirement for excising long segments of artery. Objective The objective of this study is to examine the use of ultrasound-guided biopsy of the temporal artery in the diagnosis of TA. Ultrasound-guided biopsy will be compared to the standard random biopsy generally in use. Appropriate statistical methods will be employed. Methods The Vascular Laboratory in Shaare Zedek Medical Center performs approximately 200 Doppler ultrasound studies of the temporal artery each year at the request of community-based physicians. Some of these patients are then also referred for biopsy of the temporal artery at various surgical facilities in the city. In collaboration with the referring physician, the patients will be offered a combined diagnostic Doppler ultrasound and guided biopsy on the basis of clinical guidelines and according to the ultrasound findings as described below. Patients suffering from signs and symptoms consistent with TA and who have not undergone previous temporal artery biopsy will be included. Patients suffering from isolated polymyalgia rheumatica will be excluded. Patients who are already undergoing steroid treatment will be excluded. Patients with an ultrasound study that is positive for the dark halo sign will be divided into two groups on a random basis after obtaining informed consent. One group will undergo ultrasound-guided biopsy, while the other will undergo biopsy as is the standard practice in our institution - a 1-2cm length of temporal artery will be excised from the preauricular area. If the ultrasound is negative, no biopsy will be done in the setting of this study. It is expected that about 50 patients will be accrued during the 6-month study period. Differences in outcome will be analyzed using Fishers exact test. Approval from the Helsinki committee of Shaare Zedek Medical Center has been requested.

NCT ID: NCT00315497 Completed - Temporal Arteritis Clinical Trials

Determining Disease Activity Biomarkers in Individuals With Giant Cell Arteritis

Start date: April 2006
Phase:
Study type: Observational

Giant cell arteritis (GCA), also known as temporal arteritis, is a disease that usually only occurs in older adults. GCA causes inflammation of blood vessels, or vasculitis. In order to properly treat this disease, it is critical that the level of disease activity can be determined over the course of the disease. The purpose of this study is to determine new biological markers, or biomarkers, that may be used to assess the severity of disease in people with GCA.

NCT ID: NCT00315471 Completed - Clinical trials for Takayasu's Arteritis

Determining Disease Activity Biomarkers in Individuals With Takayasu's Arteritis

Start date: April 2006
Phase:
Study type: Observational

Takayasu's arteritis is a rare disorder that causes swelling and damage to the large arteries in the body, such as the aorta. In order to ensure proper treatment, measuring disease activity is critical. The purpose of this study is to establish new biological markers (biomarkers) to assess the severity of disease in people with Takayasu's arteritis.

NCT ID: NCT00305539 Completed - Clinical trials for Giant Cell Arteritis

HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis

Start date: May 2006
Phase: Phase 3
Study type: Interventional

Hypothesis: In giant cell arteritis (GCA), a short initial treatment with anti-TNF may allow a faster decrease of steroids dosage and therefore avoid some of the adverse events of steroids.

NCT ID: NCT00221806 Recruiting - Arteritis Clinical Trials

Comparison of Two Under Knee Lower Limb Bypass Types:Endothelialised Prosthesis Versus Autologous Vein Graft

Start date: June 2004
Phase: Phase 2
Study type: Interventional

The aim of this project is to improve the hemocompatibility of vascular prosthesis with a complete covering of its endoluminal surface with autologous endothelial cells. The objective is to obtain a better bypass permeability with arterial prosthesis replacing low diameter vessels in lower limbs

NCT ID: NCT00221715 Completed - Diabetes Clinical Trials

Comparison of Two Lower Limb Bypass Types : Prosthesis Versus Autologous Vein

REVA
Start date: July 2002
Phase: N/A
Study type: Interventional

When medical treatments fail, critical ischemia of the lower limb often leads to surgery, i.e. above knee femoro popliteal bypass. This bypass can be performed either with DACRON or PTFE prosthesis or with the autologous saphenous vein. Both technics are used but they have not been compared regarding bypass permeability and limb salvage. Thus, this study will compare the permeability rate of above knee femoro popliteal surgery whether performed with autologous vein versus prosthesis

NCT ID: NCT00076726 Terminated - Clinical trials for Giant Cell Arteritis

A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Giant Cell Arteritis

Start date: November 2003
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy (effectiveness) of Infliximab (Remicade) in patients with Giant Cell Arteritis. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.

NCT ID: NCT00006055 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases

Start date: March 2000
Phase: N/A
Study type: Interventional

OBJECTIVES: I. Determine whether there is prompt engraftment after autologous peripheral blood stem cell transplantation using filgrastim (G-CSF) mobilization in patients with life threatening autoimmune diseases. II. Determine the kinetics of T- and B-cell immune reconstitution after a combination of timed plasmapheresis, high dose cyclophosphamide and total lymphoid irradiation, and posttransplant immunosuppression with cyclosporine in these patients. III. Determine whether this treatment regimen beneficially influences the clinical course of these patients.

NCT ID: NCT00004686 Completed - Clinical trials for Giant Cell Arteritis

Phase II Randomized Study of Glucocorticoids With or Without Methotrexate for Treatment of Giant Cell Arteritis

Start date: February 1994
Phase: Phase 2
Study type: Interventional

OBJECTIVES: I. Compare the long term outcomes in patients with giant cell arteritis after glucocorticoid treatment with or without methotrexate. II. Compare remission relapse rates in these patients after glucocorticoid therapy with or without methotrexate. III. Determine whether adjunctive use of methotrexate lowers cumulative dose and duration of glucocorticoid therapy and whether there is less treatment related morbidity and mortality. IV. Demonstrate the feasibility of long term, double blind, placebo controlled, randomized, multicenter trials for treatment of systemic vasculitides.